Trial Outcomes & Findings for Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years (NCT NCT00761631)
NCT ID: NCT00761631
Last Updated: 2026-07-21
Results Overview
Percentage of participants achieving world health organization (WHO) predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on observed proportion of participants.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1200 participants
Primary outcome timeframe
28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2
Results posted on
2026-07-21
Participant Flow
Participants were stratified by age group. Group 1 included participants aged greater than (\>) 15 months to less than (\<) 2 years. Group 2 included participants aged greater than or equal to (\>=) 2 to \<5 years. Group 3 included participants aged \>=5 to \<10 years. Group 4 included participants aged \>=10 to \<18 years.
Participant milestones
| Measure |
13vPnC Group 1 (Cohort 1)
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7-valent pneumococcal conjugate vaccine (7vPnC). Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 2 (Cohort 1)
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 1 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 2 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 3
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
|
13vPnC Group 4
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
126
|
181
|
176
|
119
|
299
|
299
|
|
Overall Study
Vaccinated Dose 1
|
124
|
179
|
175
|
118
|
294
|
298
|
|
Overall Study
Vaccinated Dose 2
|
112
|
0
|
165
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
111
|
174
|
160
|
116
|
277
|
294
|
|
Overall Study
NOT COMPLETED
|
15
|
7
|
16
|
3
|
22
|
5
|
Reasons for withdrawal
| Measure |
13vPnC Group 1 (Cohort 1)
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7-valent pneumococcal conjugate vaccine (7vPnC). Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 2 (Cohort 1)
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 1 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 2 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 3
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
|
13vPnC Group 4
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
|
|---|---|---|---|---|---|---|
|
Overall Study
Parent/legal guardian request
|
8
|
3
|
8
|
0
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
7
|
1
|
6
|
1
|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
1
|
5
|
1
|
|
Overall Study
Randomized, not treated
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Failed to return
|
1
|
0
|
1
|
1
|
5
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years
Baseline characteristics by cohort
| Measure |
13vPnC Group 1 (Cohort 1 and 2)
n=302 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to and after protocol amendment to increase sample size (Cohort 1 and Cohort 2, combined)
|
13vPnC Group 2 (Cohort 1 and 2)
n=300 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to and after protocol amendment to increase sample size (Cohort 1 and Cohort 2, combined)
|
13vPnC Group 3
n=299 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
|
13vPnC Group 4
n=299 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
|
Total
n=1200 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
>15 months to <2 years
|
302 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
302 Participants
n=568 Participants
|
|
Age, Customized
>=2 years to <5 years
|
0 Participants
n=9 Participants
|
300 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
300 Participants
n=568 Participants
|
|
Age, Customized
>=5 years to <10 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
299 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
299 Participants
n=568 Participants
|
|
Age, Customized
>10 years to <18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
299 Participants
n=265 Participants
|
299 Participants
n=568 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=9 Participants
|
139 Participants
n=27 Participants
|
155 Participants
n=267 Participants
|
136 Participants
n=265 Participants
|
578 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
154 Participants
n=9 Participants
|
161 Participants
n=27 Participants
|
144 Participants
n=267 Participants
|
163 Participants
n=265 Participants
|
622 Participants
n=568 Participants
|
PRIMARY outcome
Timeframe: 28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2Population: Evaluable Immunogenicity Population (EIP): all participants who met all inclusion criteria, received all assigned doses of study vaccine, had at least 1 valid and determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis and no major protocol violations.
Percentage of participants achieving world health organization (WHO) predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on observed proportion of participants.
Outcome measures
| Measure |
13vPnC Group 1 (Cohort 1)
n=109 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 2 (Cohort 1)
n=175 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 1 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 2 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 3
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
|
13vPnC Group 4
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Common serotypes - serotype 4
|
98.2 Percentage of participants
Interval 93.5 to 99.8
|
100.0 Percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Common serotypes - serotype 6B
|
100.0 Percentage of participants
Interval 96.7 to 100.0
|
100.0 Percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Common serotypes - serotype 9V
|
100.0 Percentage of participants
Interval 96.7 to 100.0
|
100.0 Percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Common serotypes - serotype 14
|
100.0 Percentage of participants
Interval 96.7 to 100.0
|
100.0 Percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Common serotypes - serotype 18C
|
100.0 Percentage of participants
Interval 96.7 to 100.0
|
100.0 Percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Common serotypes - serotype 19F
|
100.0 Percentage of participants
Interval 96.7 to 100.0
|
100.0 Percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Common serotypes - serotype 23F
|
99.1 Percentage of participants
Interval 95.0 to 100.0
|
100.0 Percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Additional serotypes - serotype 1
|
100.0 Percentage of participants
Interval 96.7 to 100.0
|
98.9 Percentage of participants
Interval 95.9 to 99.9
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Additional serotypes - serotype 3
|
94.5 Percentage of participants
Interval 88.4 to 98.0
|
92.0 Percentage of participants
Interval 86.9 to 95.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Additional serotypes - serotype 5
|
100.0 Percentage of participants
Interval 96.7 to 100.0
|
98.9 Percentage of participants
Interval 95.9 to 99.9
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Additional serotypes - serotype 6A
|
100.0 Percentage of participants
Interval 96.7 to 100.0
|
100.0 Percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Additional serotypes - serotype 7F
|
100.0 Percentage of participants
Interval 96.7 to 100.0
|
100.0 Percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Additional serotypes - serotype 19A
|
100.0 Percentage of participants
Interval 96.7 to 100.0
|
100.0 Percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 to 42 days after dose 1 for Group 3Population: EIP: participants who met all inclusion criteria, received all assigned doses of study vaccine;had at least 1 valid, determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis;no major protocol violations. N (number of participants analyzed)=participants with determinate antibody concentration.
Antibody GMC for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for after dose 1 blood draw.
Outcome measures
| Measure |
13vPnC Group 1 (Cohort 1)
n=171 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 2 (Cohort 1)
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 1 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 2 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 3
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
|
13vPnC Group 4
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
Additional serotypes - serotype 1
|
3.57 mcg/mL
Interval 3.05 to 4.18
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
Common serotypes - serotype 4
|
8.45 mcg/mL
Interval 7.24 to 9.87
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
Common serotypes - serotype 6B
|
53.56 mcg/mL
Interval 45.48 to 63.07
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
Common serotypes - serotype 9V
|
9.51 mcg/mL
Interval 8.38 to 10.78
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
Common serotypes - serotype 14
|
29.36 mcg/mL
Interval 24.78 to 34.78
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
Common serotypes - serotype 18C
|
8.23 mcg/mL
Interval 7.13 to 9.51
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
Common serotypes - serotype 19F
|
17.58 mcg/mL
Interval 14.95 to 20.67
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
Common serotypes - serotype 23F
|
11.26 mcg/mL
Interval 9.79 to 12.95
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
Additional serotypes - serotype 3
|
2.38 mcg/mL
Interval 2.07 to 2.74
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
Additional serotypes - serotype 5
|
5.52 mcg/mL
Interval 4.82 to 6.32
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
Additional serotypes - serotype 6A
|
21.51 mcg/mL
Interval 18.15 to 25.51
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
Additional serotypes - serotype 7F
|
6.24 mcg/mL
Interval 5.49 to 7.08
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
Additional serotypes - serotype 19A
|
17.18 mcg/mL
Interval 15.01 to 19.67
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 to 42 days after dose 1 for Group 3 and 4Population: EIP: participants who met all inclusion criteria, received all assigned doses of study vaccine;had at least 1 valid, determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis;no major protocol violations. N (number of participants analyzed)=participants with a determinate antibody titer.
Serotype-specific OPA GMTs for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for after dose 1 blood draw.
Outcome measures
| Measure |
13vPnC Group 1 (Cohort 1)
n=189 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 2 (Cohort 1)
n=181 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 1 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 2 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 3
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
|
13vPnC Group 4
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
|
|---|---|---|---|---|---|---|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
Common serotypes - serotype 4
|
6912 titer
Interval 6101.2 to 7831.4
|
4629 titer
Interval 4017.2 to 5334.3
|
—
|
—
|
—
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
Common serotypes - serotype 6B
|
14224 titer
Interval 12316.4 to 16427.3
|
14996 titer
Interval 13164.1 to 17083.1
|
—
|
—
|
—
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
Common serotypes - serotype 9V
|
4485 titer
Interval 4001.1 to 5027.5
|
4733 titer
Interval 4203.3 to 5328.4
|
—
|
—
|
—
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
Common serotypes - serotype 14
|
6894 titer
Interval 6028.3 to 7884.0
|
4759 titer
Interval 4120.4 to 5497.0
|
—
|
—
|
—
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
Common serotypes - serotype 18C
|
6263 titer
Interval 5436.4 to 7215.1
|
8815 titer
Interval 7738.2 to 10041.0
|
—
|
—
|
—
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
Common serotypes - serotype 19F
|
2280 titer
Interval 1949.4 to 2667.6
|
1559 titer
Interval 1293.3 to 1878.9
|
—
|
—
|
—
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
Common serotypes - serotype 23F
|
3808 titer
Interval 3354.7 to 4322.6
|
3245 titer
Interval 2818.8 to 3735.5
|
—
|
—
|
—
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
Additional serotypes - serotype 1
|
319 titer
Interval 271.2 to 376.0
|
187 titer
Interval 160.4 to 218.6
|
—
|
—
|
—
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
Additional serotypes - serotype 3
|
114 titer
Interval 100.4 to 129.4
|
202 titer
Interval 180.9 to 226.3
|
—
|
—
|
—
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
Additional serotypes - serotype 5
|
336 titer
Interval 270.3 to 417.6
|
491 titer
Interval 426.3 to 565.3
|
—
|
—
|
—
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
Additional serotypes - serotype 6A
|
9928 titer
Interval 8457.0 to 11654.8
|
7514 titer
Interval 6350.8 to 8890.7
|
—
|
—
|
—
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
Additional serotypes - serotype 7F
|
6584 titer
Interval 5829.4 to 7435.5
|
10334 titer
Interval 9099.0 to 11736.8
|
—
|
—
|
—
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
Additional serotypes - serotype 19A
|
1276 titer
Interval 1131.7 to 1439.0
|
1180 titer
Interval 1047.5 to 1329.4
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the day of dose 1 (Day 1) to Day 7 after dose 1Population: Dose 1 Safety Population: all participants who received the first dose of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm).
Outcome measures
| Measure |
13vPnC Group 1 (Cohort 1)
n=110 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 2 (Cohort 1)
n=158 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 1 (Cohort 2)
n=151 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 2 (Cohort 2)
n=102 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 3
n=270 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
|
13vPnC Group 4
n=285 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1
Tenderness Any (n=108,155, 148,102,265,283)
|
50.9 Percentage of participants
|
61.9 Percentage of participants
|
45.3 Percentage of participants
|
62.7 Percentage of participants
|
86.8 Percentage of participants
|
89.0 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1
Tenderness Significant (n=92,141,133,92,221,242)
|
7.6 Percentage of participants
|
10.6 Percentage of participants
|
5.3 Percentage of participants
|
13.0 Percentage of participants
|
19.5 Percentage of participants
|
43.8 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1
Swelling Any (n=97,144,142,90,226,233)
|
25.8 Percentage of participants
|
22.2 Percentage of participants
|
17.6 Percentage of participants
|
20.0 Percentage of participants
|
37.6 Percentage of participants
|
36.9 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1
Swelling Mild (n=94,143,141,89,220,221)
|
21.3 Percentage of participants
|
20.3 Percentage of participants
|
14.2 Percentage of participants
|
13.5 Percentage of participants
|
21.8 Percentage of participants
|
22.6 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1
Swelling Moderate (n=94,141,135,89,219,226)
|
9.6 Percentage of participants
|
5.7 Percentage of participants
|
7.4 Percentage of participants
|
11.2 Percentage of participants
|
21.9 Percentage of participants
|
21.2 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1
Swelling Severe (n=90,138,131,88,211,214)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
1.1 Percentage of participants
|
3.3 Percentage of participants
|
1.9 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1
Redness Any (n=103,149,143,91,233,232)
|
39.8 Percentage of participants
|
34.9 Percentage of participants
|
18.9 Percentage of participants
|
36.3 Percentage of participants
|
42.9 Percentage of participants
|
30.2 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1
Redness Mild (n=99,146,143,90,226,226)
|
31.3 Percentage of participants
|
31.5 Percentage of participants
|
16.8 Percentage of participants
|
31.1 Percentage of participants
|
27.9 Percentage of participants
|
21.2 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1
Redness Moderate (n=94,142,135,89,218,221)
|
12.8 Percentage of participants
|
9.9 Percentage of participants
|
5.9 Percentage of participants
|
14.6 Percentage of participants
|
22.0 Percentage of participants
|
14.0 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1
Redness Severe (n=90,138,131,88,212,213)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.8 Percentage of participants
|
1.1 Percentage of participants
|
3.3 Percentage of participants
|
1.9 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the day of dose 2 (Day 1) to Day 7 of dose 2Population: Dose 2 Safety Population: all participants who received 2 doses of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm).
Outcome measures
| Measure |
13vPnC Group 1 (Cohort 1)
n=90 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 2 (Cohort 1)
n=131 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 1 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 2 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 3
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
|
13vPnC Group 4
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2
Tenderness Any (n=87, 125)
|
57.5 Percentage of participants
|
55.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2
Tenderness Significant (n=68, 101)
|
8.8 Percentage of participants
|
9.9 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2
Swelling Any (n=73, 105)
|
23.3 Percentage of participants
|
17.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2
Swelling Mild (n=72, 104)
|
22.2 Percentage of participants
|
15.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2
Swelling Moderate (n=69, 102)
|
2.9 Percentage of participants
|
7.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2
Swelling Severe (n=68, 98)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2
Redness Any (n=76, 110)
|
35.5 Percentage of participants
|
23.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2
Redness Mild (n=74, 108)
|
33.8 Percentage of participants
|
18.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2
Redness Moderate (n=70, 100)
|
7.1 Percentage of participants
|
6.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2
Redness Severe (n=68, 98)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the day of dose 1 (Day 1) to Day 7 of dose 1Population: Dose 1 Safety Population: all participants who received the first dose of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.
Systemic events (any fever \>=38 degrees \[deg\] Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary.
Outcome measures
| Measure |
13vPnC Group 1 (Cohort 1)
n=112 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 2 (Cohort 1)
n=157 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 1 (Cohort 2)
n=165 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 2 (Cohort 2)
n=107 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 3
n=250 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
|
13vPnC Group 4
n=253 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1
Fever >=38 to <=39 degC(n=92,138,137,90,212,214)
|
16.3 Percentage of participants
|
5.1 Percentage of participants
|
17.5 Percentage of participants
|
14.4 Percentage of participants
|
4.2 Percentage of participants
|
5.1 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1
Fever >39 but <=40 degC(n=90,138,130,89,212,212)
|
4.4 Percentage of participants
|
0.7 Percentage of participants
|
4.6 Percentage of participants
|
3.4 Percentage of participants
|
2.4 Percentage of participants
|
0.5 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1
Fever >40 degC (n=90,138,130,88,210,212)
|
0.0 Percentage of participants
|
0.7 Percentage of participants
|
0.0 Percentage of participants
|
1.1 Percentage of participants
|
0.5 Percentage of participants
|
0.5 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1
Decreased appetite (n=99,149,146,94,227,223)
|
42.4 Percentage of participants
|
24.8 Percentage of participants
|
39.7 Percentage of participants
|
34.0 Percentage of participants
|
22.9 Percentage of participants
|
22.9 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1
Irritability (n=108,151,156,102,234,234)
|
60.2 Percentage of participants
|
39.7 Percentage of participants
|
72.4 Percentage of participants
|
52.0 Percentage of participants
|
31.2 Percentage of participants
|
25.2 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1
Increased sleep (n=98,145,146,97,226,229)
|
32.7 Percentage of participants
|
15.9 Percentage of participants
|
37.0 Percentage of participants
|
23.7 Percentage of participants
|
21.2 Percentage of participants
|
26.6 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1
Decreased sleep (n=97,143,140,91,212,224)
|
22.7 Percentage of participants
|
14.0 Percentage of participants
|
32.1 Percentage of participants
|
18.7 Percentage of participants
|
5.7 Percentage of participants
|
18.8 Percentage of participants
|
|
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1
Hives (urticaria) (n=90,139,131,88,213,214)
|
1.1 Percentage of participants
|
0.7 Percentage of participants
|
1.5 Percentage of participants
|
4.5 Percentage of participants
|
1.9 Percentage of participants
|
1.4 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the day of dose 2 (Day 1) to Day 7 of dose 2Population: Dose 2 Safety Population: all participants who received 2 doses of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.
Systemic events (any fever \>=38 deg C, decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may have been represented in more than 1 category. Percentage of participants = number of participants reporting specified systemic event divided by number of participants reporting yes for at least 1 day or no for all days.
Outcome measures
| Measure |
13vPnC Group 1 (Cohort 1)
n=91 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 2 (Cohort 1)
n=137 Participants
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 1 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 2 (Cohort 2)
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 3
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
|
13vPnC Group 4
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2
Fever >=38 but <=39 degC (n=70,101)
|
14.3 Percentage of participants
|
11.9 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2
Fever >39 but <=40 degC (n=68, 100)
|
4.4 Percentage of participants
|
2.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2
Fever >40 degC (n=68, 98)
|
0.0 Percentage of participants
|
1.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2
Decreased appetite (n=77, 113)
|
40.3 Percentage of participants
|
34.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2
Irritability (n=86, 126)
|
65.1 Percentage of participants
|
61.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2
Increased sleep (n=75, 109)
|
29.3 Percentage of participants
|
23.9 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2
Decreased sleep (n=77, 112)
|
28.6 Percentage of participants
|
26.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2
Hives (urticaria) (n=68, 98)
|
2.9 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
—
|
Adverse Events
13vPnC Group 1 (Cohort 1) Dose 1
Serious events: 0 serious events
Other events: 112 other events
Deaths: 0 deaths
13vPnC Group 1 (Cohort 1) Dose 2
Serious events: 2 serious events
Other events: 91 other events
Deaths: 0 deaths
13vPnC Group 2 (Cohort 1) Dose 1
Serious events: 1 serious events
Other events: 158 other events
Deaths: 0 deaths
13vPnC Group 1 (Cohort 2) Dose 1
Serious events: 1 serious events
Other events: 165 other events
Deaths: 0 deaths
13vPnC Group 1 (Cohort 2) Dose 2
Serious events: 4 serious events
Other events: 137 other events
Deaths: 0 deaths
13vPnC Group 2 (Cohort 2) Dose 1
Serious events: 0 serious events
Other events: 107 other events
Deaths: 0 deaths
6-Month Follow-up 13vPnC Group 1 (Cohort 1 and 2)
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
6-Month Follow-up 13vPnC Group 2 (Cohort 1 and 2)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
13vPnC Group 3
Serious events: 1 serious events
Other events: 242 other events
Deaths: 0 deaths
6-Month Follow-up 13vPnC Group 3
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
13vPnC Group 4
Serious events: 0 serious events
Other events: 258 other events
Deaths: 0 deaths
6-Month Follow-up 13vPnC Group 4
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC Group 1 (Cohort 1) Dose 1
n=124 participants at risk
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 1 (Cohort 1) Dose 2
n=112 participants at risk
13vPnC (0.5mL dose) administered intramuscularly anytime from Day 56 to Day 70. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 2 (Cohort 1) Dose 1
n=179 participants at risk
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 1 (Cohort 2) Dose 1
n=175 participants at risk
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 1 (Cohort 2) Dose 2
n=165 participants at risk
13vPnC (0.5mL dose) administered intramuscularly anytime from Day 56 to Day 70. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 2 (Cohort 2) Dose 1
n=118 participants at risk
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
6-Month Follow-up 13vPnC Group 1 (Cohort 1 and 2)
n=299 participants at risk
6-month follow-up telephone contact for participants in Group 1 (Cohort 1 and 2).
|
6-Month Follow-up 13vPnC Group 2 (Cohort 1 and 2)
n=297 participants at risk
6-month follow-up telephone contact for participants in Group 2 (Cohort 1 and 2).
|
13vPnC Group 3
n=294 participants at risk
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
|
6-Month Follow-up 13vPnC Group 3
n=294 participants at risk
6-month follow-up telephone contact for participants in Group 3.
|
13vPnC Group 4
n=298 participants at risk
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
|
6-Month Follow-up 13vPnC Group 4
n=298 participants at risk
6 -Month Follow-up Telephone Contact for participants in Group 4.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
1/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
1/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.33%
1/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.33%
1/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.33%
1/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.33%
1/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
Other adverse events
| Measure |
13vPnC Group 1 (Cohort 1) Dose 1
n=124 participants at risk
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 1 (Cohort 1) Dose 2
n=112 participants at risk
13vPnC (0.5mL dose) administered intramuscularly anytime from Day 56 to Day 70. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 2 (Cohort 1) Dose 1
n=179 participants at risk
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
|
13vPnC Group 1 (Cohort 2) Dose 1
n=175 participants at risk
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 1 (Cohort 2) Dose 2
n=165 participants at risk
13vPnC (0.5mL dose) administered intramuscularly anytime from Day 56 to Day 70. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
13vPnC Group 2 (Cohort 2) Dose 1
n=118 participants at risk
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
|
6-Month Follow-up 13vPnC Group 1 (Cohort 1 and 2)
n=299 participants at risk
6-month follow-up telephone contact for participants in Group 1 (Cohort 1 and 2).
|
6-Month Follow-up 13vPnC Group 2 (Cohort 1 and 2)
n=297 participants at risk
6-month follow-up telephone contact for participants in Group 2 (Cohort 1 and 2).
|
13vPnC Group 3
n=294 participants at risk
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
|
6-Month Follow-up 13vPnC Group 3
n=294 participants at risk
6-month follow-up telephone contact for participants in Group 3.
|
13vPnC Group 4
n=298 participants at risk
13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
|
6-Month Follow-up 13vPnC Group 4
n=298 participants at risk
6 -Month Follow-up Telephone Contact for participants in Group 4.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Ear infection
|
1.6%
2/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Gastroenteritis viral
|
1.6%
2/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.68%
2/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.7%
3/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bronchitis
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
1/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.7%
3/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bronchiolitis
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Eye infection
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Impetigo
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Influenza
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.7%
2/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.0%
3/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.7%
5/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Lice infestation
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Otitis media chronic
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Paronychia
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pneumonia viral
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Subcutaneous abscess
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Skin infection
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
1/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
1/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
1/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.0%
6/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Intertrigo candida
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Otitis externa
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.85%
1/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.67%
2/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Urethritis
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Viral rash
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Cellulitis streptococcal
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Coxsackie viral infection
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Erythema infectiosum
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.2%
2/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
1/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
1/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.85%
1/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Redness (mild)
|
31.3%
31/99 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
33.8%
25/74 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
31.5%
46/146 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
16.8%
24/143 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
18.5%
20/108 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
31.1%
28/90 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
27.9%
63/226 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
21.2%
48/226 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Investigations
Cardiac murmur
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Metabolism and nutrition disorders
Anorexia
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.85%
1/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Headache
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
1/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.7%
2/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.0%
3/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
3.4%
10/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Speech disorder developmental
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Breath holding
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Asperger's disorder
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.85%
1/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.85%
1/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Reproductive system and breast disorders
Penile adhesion
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
5/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
3.9%
7/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
3.4%
6/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.2%
7/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.5%
3/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
3.4%
10/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.7%
5/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.0%
5/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.8%
2/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.2%
4/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.9%
5/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.4%
4/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.5%
3/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.6%
2/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
1/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
1/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.2%
2/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.85%
1/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.0%
3/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.2%
4/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.5%
3/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.68%
2/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.67%
2/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
1/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.7%
5/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
1/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.33%
1/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.85%
1/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.68%
2/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Conjunctivitis
|
1.6%
2/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
3.6%
4/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.8%
3/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.68%
2/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
3.4%
6/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
2/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.8%
2/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.9%
5/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.85%
1/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.8%
2/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.85%
1/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.33%
1/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.6%
2/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.81%
1/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Tenderness (any)
|
50.9%
55/108 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
57.5%
50/87 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
61.9%
96/155 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
45.3%
67/148 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
55.2%
69/125 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
62.7%
64/102 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
86.8%
230/265 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
89.0%
252/283 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Tenderness (significant)
|
7.6%
7/92 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
8.8%
6/68 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
10.6%
15/141 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
5.3%
7/133 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
9.9%
10/101 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
13.0%
12/92 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
19.5%
43/221 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
43.8%
106/242 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Swelling (any)
|
25.8%
25/97 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
23.3%
17/73 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
22.2%
32/144 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
17.6%
25/142 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
17.1%
18/105 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
20.0%
18/90 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
37.6%
85/226 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
36.9%
86/233 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Swelling (mild)
|
21.3%
20/94 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
22.2%
16/72 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
20.3%
29/143 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
14.2%
20/141 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
15.4%
16/104 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
13.5%
12/89 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
21.8%
48/220 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
22.6%
50/221 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Swelling (moderate)
|
9.6%
9/94 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.9%
2/69 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
5.7%
8/141 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
7.4%
10/135 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
7.8%
8/102 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
11.2%
10/89 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
21.9%
48/219 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
21.2%
48/226 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Swelling (severe)
|
0.00%
0/90 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/68 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/138 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/131 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/98 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
1/88 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
3.3%
7/211 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.9%
4/214 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Redness (any)
|
39.8%
41/103 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
35.5%
27/76 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
34.9%
52/149 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
18.9%
27/143 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
23.6%
26/110 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
36.3%
33/91 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
42.9%
100/233 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
30.2%
70/232 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
1/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.7%
3/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Hypermetropia
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.85%
1/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Eye swelling
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
6/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.2%
4/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
3.4%
6/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.8%
3/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.7%
2/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.0%
3/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
7/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
1/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.8%
3/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.5%
3/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.7%
8/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.3%
4/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.2%
2/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
1/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.85%
1/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Teething
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Duodenogastric reflux
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Pyrexia
|
4.0%
5/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.7%
3/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.7%
3/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.0%
7/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
3.0%
5/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
3.4%
4/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.4%
7/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.0%
3/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Influenza like illness
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site reaction
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.85%
1/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site pruritus
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
1/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Otitis media
|
12.1%
15/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.5%
5/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
6.7%
12/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
6.9%
12/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
6.7%
11/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.85%
1/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.0%
3/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.67%
2/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
9/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
8.0%
9/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.7%
3/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
8.6%
15/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
8.5%
14/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.85%
1/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.68%
2/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.0%
3/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
4/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
1/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.0%
7/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.2%
2/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.5%
3/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.0%
3/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.0%
3/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Sinusitis
|
2.4%
3/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.7%
3/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.2%
4/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.3%
4/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.7%
2/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.0%
3/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.7%
5/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Rhinitis
|
2.4%
3/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.6%
8/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.8%
3/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Otitis media acute
|
2.4%
3/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.57%
1/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Viral infection
|
1.6%
2/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.8%
5/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.3%
4/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.8%
3/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.5%
3/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.0%
3/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.3%
4/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Croup infectious
|
1.6%
2/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.89%
1/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.0%
7/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.85%
1/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Gastroenteritis
|
1.6%
2/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pharyngitis
|
1.6%
2/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
1/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.61%
1/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.5%
3/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.68%
2/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.7%
5/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Redness (moderate)
|
12.8%
12/94 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
7.1%
5/70 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
9.9%
14/142 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
5.9%
8/135 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
6.0%
6/100 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
14.6%
13/89 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
22.0%
48/218 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
14.0%
31/221 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Redness (severe)
|
0.00%
0/90 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/68 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/138 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.76%
1/131 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/98 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
1/88 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
3.3%
7/212 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.9%
4/213 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fever >=38 degreesC but <=39 degreesC
|
16.3%
15/92 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
14.3%
10/70 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
5.1%
7/138 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
17.5%
24/137 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
11.9%
12/101 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
14.4%
13/90 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.2%
9/212 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
5.1%
11/214 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fever >39 degreesC but <=40 degreesC
|
4.4%
4/90 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.4%
3/68 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.72%
1/138 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.6%
6/130 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.0%
2/100 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
3.4%
3/89 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.4%
5/212 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/212 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fever >40 degreesC
|
0.00%
0/90 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/68 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.72%
1/138 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/130 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.0%
1/98 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
1/88 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.48%
1/210 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/212 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Decreased appetite
|
42.4%
42/99 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
40.3%
31/77 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
24.8%
37/149 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
39.7%
58/146 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
34.5%
39/113 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
34.0%
32/94 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
22.9%
52/227 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
22.9%
51/223 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Irritability
|
60.2%
65/108 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
65.1%
56/86 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
39.7%
60/151 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
72.4%
113/156 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
61.1%
77/126 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
52.0%
53/102 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
31.2%
73/234 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
25.2%
59/234 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Increased sleep
|
32.7%
32/98 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
29.3%
22/75 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
15.9%
23/145 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
37.0%
54/146 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
23.9%
26/109 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
23.7%
23/97 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
21.2%
48/226 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
26.6%
61/229 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Decreased sleep
|
22.7%
22/97 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
28.6%
22/77 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
14.0%
20/143 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
32.1%
45/140 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
26.8%
30/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
18.7%
17/91 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
5.7%
12/212 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
18.8%
42/224 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Hives (urticaria)
|
1.1%
1/90 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.9%
2/68 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.72%
1/139 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.5%
2/131 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/98 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.5%
4/88 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.9%
4/213 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.4%
3/214 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.0%
3/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Dermatophytosis
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.67%
2/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Syncope
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.67%
2/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Myopia
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Uvulitis
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Chills
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.67%
2/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Pain
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.67%
2/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site pain
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Furuncle
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Investigations
Heart rate decreased
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.67%
2/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Migraine
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Depression
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.67%
2/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Acanthosis nigricans
|
0.00%
0/124 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/112 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/175 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/165 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/118 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/299 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/297 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/294 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.34%
1/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/298 • Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER