Trial Outcomes & Findings for Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study (NCT NCT03918629)
NCT ID: NCT03918629
Last Updated: 2024-01-10
Results Overview
Adjusted GMCs and 2-sided 95% confidence intervals (CIs) of toxin A and toxin B specific neutralizing antibody levels were calculated by exponentiating the least square (LS) means and the corresponding CIs based on analysis of logarithmically transformed concentrations using a linear regression model with terms of baseline concentration (log scale) and vaccine group. EIP at Month 7 (EI7): all enrolled participants who received all 3 doses of investigational product; had blood drawn for assay testing within 28 to 47 days after visit 4; had valid and determinate assay results for either toxin A or B for the specified analysis at Month 7; had no major protocol deviations.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1994 participants
Primary outcome timeframe
Month 7
Results posted on
2024-01-10
Participant Flow
2160 participants signed the inform consent form (ICF).166 participants were screen failures who did not meet criteria and were not enrolled. 1994 participants were randomized, and 1991 participants received study treatment.
Participant milestones
| Measure |
2-Dose Clostridium Difficile Vaccine
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
3-Dose Clostridium Difficile Vaccine
Participants were randomized to receive 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
|---|---|---|
|
Overall Study
STARTED
|
996
|
998
|
|
Overall Study
Vaccinated With Dose 1
|
994
|
997
|
|
Overall Study
Vaccinated With Dose 2
|
961
|
964
|
|
Overall Study
Vaccinated With Dose 3
|
897
|
917
|
|
Overall Study
COMPLETED
|
863
|
880
|
|
Overall Study
NOT COMPLETED
|
133
|
118
|
Reasons for withdrawal
| Measure |
2-Dose Clostridium Difficile Vaccine
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
3-Dose Clostridium Difficile Vaccine
Participants were randomized to receive 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
|---|---|---|
|
Overall Study
Adverse Event
|
19
|
20
|
|
Overall Study
Death
|
14
|
7
|
|
Overall Study
Lost to Follow-up
|
36
|
28
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
7
|
4
|
|
Overall Study
Withdrawal by Subject
|
47
|
47
|
|
Overall Study
Other
|
7
|
11
|
|
Overall Study
Randomized but not vaccinated
|
2
|
1
|
Baseline Characteristics
Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study
Baseline characteristics by cohort
| Measure |
2-Dose Clostridium Difficile Vaccine
n=994 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
3-Dose Clostridium Difficile Vaccine
n=997 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
Total
n=1991 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.8 Years
STANDARD_DEVIATION 7.6 • n=99 Participants
|
67.8 Years
STANDARD_DEVIATION 7.5 • n=107 Participants
|
67.8 Years
STANDARD_DEVIATION 7.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
583 Participants
n=99 Participants
|
598 Participants
n=107 Participants
|
1181 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
411 Participants
n=99 Participants
|
399 Participants
n=107 Participants
|
810 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
113 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
202 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
869 Participants
n=99 Participants
|
889 Participants
n=107 Participants
|
1758 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
88 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
178 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
893 Participants
n=99 Participants
|
892 Participants
n=107 Participants
|
1785 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Month 7Population: EI7 population. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies participants with valid and determinate assay results for the specified assay at both baseline and the given sampling time point.
Adjusted GMCs and 2-sided 95% confidence intervals (CIs) of toxin A and toxin B specific neutralizing antibody levels were calculated by exponentiating the least square (LS) means and the corresponding CIs based on analysis of logarithmically transformed concentrations using a linear regression model with terms of baseline concentration (log scale) and vaccine group. EIP at Month 7 (EI7): all enrolled participants who received all 3 doses of investigational product; had blood drawn for assay testing within 28 to 47 days after visit 4; had valid and determinate assay results for either toxin A or B for the specified analysis at Month 7; had no major protocol deviations.
Outcome measures
| Measure |
2-Dose Clostridium Difficile Vaccine
n=795 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
3-Dose Clostridium Difficile Vaccine
n=812 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
|---|---|---|
|
Adjusted Geometric Mean Concentration (GMC) of Clostridium Difficile Toxin A and Toxin B Specific Neutralizing Antibodies at Month 7 for Evaluable Immunogenicity Population (EIP)
Toxin A
|
693.0 Neutralization units per milliliter
Interval 646.5 to 742.9
|
845.7 Neutralization units per milliliter
Interval 789.5 to 906.0
|
|
Adjusted Geometric Mean Concentration (GMC) of Clostridium Difficile Toxin A and Toxin B Specific Neutralizing Antibodies at Month 7 for Evaluable Immunogenicity Population (EIP)
Toxin B
|
4166.2 Neutralization units per milliliter
Interval 3759.7 to 4616.7
|
7342.9 Neutralization units per milliliter
Interval 6633.1 to 8128.5
|
PRIMARY outcome
Timeframe: Month 7Population: EI7 population. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies participants with valid and determinate assay results for the specified assay at both baseline and the given sampling time point.
Seroresponse was defined as at least a 4-fold rise from the baseline neutralizing antibody level following vaccination. 95% CI was based on Clopper-Pearson method. EI7: all enrolled participants who received all 3 doses of investigational product; had blood drawn for assay testing within 28 to 47 days after visit 4; had valid and determinate assay results for either toxin A or B for the specified analysis at Month 7; had no major protocol deviations.
Outcome measures
| Measure |
2-Dose Clostridium Difficile Vaccine
n=795 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
3-Dose Clostridium Difficile Vaccine
n=812 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
|---|---|---|
|
Percentage of Participants Achieving Seroresponse for Clostridium Difficile Toxin A and Toxin B at Month 7 for EIP
Toxin A
|
32.2 Percentage of participants
Interval 28.9 to 35.5
|
33.9 Percentage of participants
Interval 30.6 to 37.3
|
|
Percentage of Participants Achieving Seroresponse for Clostridium Difficile Toxin A and Toxin B at Month 7 for EIP
Toxin B
|
56.7 Percentage of participants
Interval 53.1 to 60.2
|
73.5 Percentage of participants
Interval 70.3 to 76.5
|
PRIMARY outcome
Timeframe: Up to 7 days after Dose 1 of investigational product at Month 0Population: Safety analysis set included all participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Local reactions included pain at injection site, redness and swelling. These were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit= 0.5 centimeter (cm). Redness and swelling were graded as mild: 2.5-5.0 cm, moderate: greater than (\>) 5.0-10.0 cm, severe: \>10.0 cm, potentially life threatening: necrosis or exfoliative dermatitis for redness, or necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, potentially life threatening: emergency room visit or hospitalization. The maximum severity was defined as highest grading of each local reaction through 7 days of vaccination.
Outcome measures
| Measure |
2-Dose Clostridium Difficile Vaccine
n=983 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
3-Dose Clostridium Difficile Vaccine
n=988 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
|---|---|---|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 1
Pain at injection site: Mild
|
19.1 Percentage of participants
Interval 16.7 to 21.7
|
17.5 Percentage of participants
Interval 15.2 to 20.0
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 1
Pain at injection site: Moderate
|
1.2 Percentage of participants
Interval 0.6 to 2.1
|
2.6 Percentage of participants
Interval 1.7 to 3.8
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 1
Pain at injection site: Severe
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.1 Percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 1
Pain at injection site: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 1
Redness: Mild
|
0.9 Percentage of participants
Interval 0.4 to 1.7
|
0.6 Percentage of participants
Interval 0.2 to 1.3
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 1
Redness: Moderate
|
0.2 Percentage of participants
Interval 0.0 to 0.7
|
0.6 Percentage of participants
Interval 0.2 to 1.3
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 1
Redness: Severe
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 1
Redness: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 1
Swelling: Mild
|
1.9 Percentage of participants
Interval 1.2 to 3.0
|
1.6 Percentage of participants
Interval 0.9 to 2.6
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 1
Swelling: Moderate
|
0.7 Percentage of participants
Interval 0.3 to 1.5
|
0.8 Percentage of participants
Interval 0.4 to 1.6
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 1
Swelling: Severe
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.1 Percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 1
Swelling: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
PRIMARY outcome
Timeframe: Up to 7 days after Dose 2 of investigational product at Month 1Population: Safety analysis set included all participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Local reactions included pain at injection site, redness and swelling. These were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit= 0.5 cm. Redness and swelling were graded as mild: 2.5-5.0 cm, moderate: \>5.0-10.0 cm, severe: \>10.0 cm, potentially life threatening: necrosis or exfoliative dermatitis for redness, or necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, potentially life threatening: emergency room visit or hospitalization. The maximum severity was defined as highest grading of each local reaction through 7 days of vaccination.
Outcome measures
| Measure |
2-Dose Clostridium Difficile Vaccine
n=937 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
3-Dose Clostridium Difficile Vaccine
n=940 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
|---|---|---|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 2
Pain at injection site: Mild
|
5.4 Percentage of participants
Interval 4.1 to 7.1
|
24.0 Percentage of participants
Interval 21.3 to 26.9
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 2
Pain at injection site: Moderate
|
0.4 Percentage of participants
Interval 0.1 to 1.1
|
4.0 Percentage of participants
Interval 2.9 to 5.5
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 2
Pain at injection site: Severe
|
0.2 Percentage of participants
Interval 0.0 to 0.8
|
0.4 Percentage of participants
Interval 0.1 to 1.1
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 2
Pain at injection site: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 2
Redness: Mild
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
2.3 Percentage of participants
Interval 1.5 to 3.5
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 2
Redness: Moderate
|
0.2 Percentage of participants
Interval 0.0 to 0.8
|
1.6 Percentage of participants
Interval 0.9 to 2.6
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 2
Redness: Severe
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.5 Percentage of participants
Interval 0.2 to 1.2
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 2
Redness: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 2
Swelling: Mild
|
0.6 Percentage of participants
Interval 0.2 to 1.4
|
3.5 Percentage of participants
Interval 2.4 to 4.9
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 2
Swelling: Moderate
|
0.3 Percentage of participants
Interval 0.1 to 0.9
|
3.2 Percentage of participants
Interval 2.2 to 4.5
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 2
Swelling: Severe
|
0.1 Percentage of participants
Interval 0.0 to 0.6
|
0.5 Percentage of participants
Interval 0.2 to 1.2
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 2
Swelling: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
PRIMARY outcome
Timeframe: Up to 7 days after Dose 3 of investigational product at Month 6Population: Safety analysis set included all participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Local reactions included pain at injection site, redness and swelling. These were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit= 0.5 cm. Redness and swelling were graded as mild: 2.5-5.0 cm, moderate: \>5.0-10.0 cm, severe: \>10.0 cm, potentially life threatening: necrosis or exfoliative dermatitis for redness, or necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, potentially life threatening: emergency room visit or hospitalization. The maximum severity was defined as highest grading of each local reaction through 7 days of vaccination.
Outcome measures
| Measure |
2-Dose Clostridium Difficile Vaccine
n=869 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
3-Dose Clostridium Difficile Vaccine
n=894 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
|---|---|---|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 3
Pain at injection site: Mild
|
23.7 Percentage of participants
Interval 20.9 to 26.7
|
23.5 Percentage of participants
Interval 20.7 to 26.4
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 3
Pain at injection site: Moderate
|
5.2 Percentage of participants
Interval 3.8 to 6.9
|
4.9 Percentage of participants
Interval 3.6 to 6.6
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 3
Pain at injection site: Severe
|
0.2 Percentage of participants
Interval 0.0 to 0.8
|
0.1 Percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 3
Pain at injection site: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 3
Redness: Mild
|
2.5 Percentage of participants
Interval 1.6 to 3.8
|
2.8 Percentage of participants
Interval 1.8 to 4.1
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 3
Redness: Moderate
|
2.2 Percentage of participants
Interval 1.3 to 3.4
|
2.1 Percentage of participants
Interval 1.3 to 3.3
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 3
Redness: Severe
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.3 Percentage of participants
Interval 0.1 to 1.0
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 3
Redness: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 3
Swelling: Mild
|
3.3 Percentage of participants
Interval 2.2 to 4.8
|
4.8 Percentage of participants
Interval 3.5 to 6.4
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 3
Swelling: Moderate
|
3.3 Percentage of participants
Interval 2.2 to 4.8
|
2.6 Percentage of participants
Interval 1.6 to 3.8
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 3
Swelling: Severe
|
0.2 Percentage of participants
Interval 0.0 to 0.8
|
0.3 Percentage of participants
Interval 0.1 to 1.0
|
|
Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 3
Swelling: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
PRIMARY outcome
Timeframe: Up to 7 days after Dose 1 of investigational product at Month 0Population: Safety analysis set included all participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild (38.0 to 38.4 degree \[deg\] Celsius \[C\]), moderate (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C) and potentially life threatening (\>40.0 deg C). Fatigue, headache, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily routine activity and potentially life threatening: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h, severe: required intravenous hydration and potentially life threatening: emergency room visit or hospitalization for hypotensive shock. The maximum severity was defined as highest grading of each systemic event through 7 days of vaccination.
Outcome measures
| Measure |
2-Dose Clostridium Difficile Vaccine
n=983 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
3-Dose Clostridium Difficile Vaccine
n=988 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
|---|---|---|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Fever: 38.0-38.4 deg C
|
0.5 Percentage of participants
Interval 0.2 to 1.2
|
0.9 Percentage of participants
Interval 0.4 to 1.7
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Fever: 38.5-38.9 deg C
|
0.2 Percentage of participants
Interval 0.0 to 0.7
|
0.1 Percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Fever: 39.0-40.0 deg C
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.1 Percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Fever: >40.0 deg C
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Fatigue: Mild
|
11.3 Percentage of participants
Interval 9.4 to 13.4
|
14.1 Percentage of participants
Interval 12.0 to 16.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Fatigue: Moderate
|
14.6 Percentage of participants
Interval 12.5 to 17.0
|
15.5 Percentage of participants
Interval 13.3 to 17.9
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Fatigue: Severe
|
1.9 Percentage of participants
Interval 1.2 to 3.0
|
1.8 Percentage of participants
Interval 1.1 to 2.9
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Fatigue: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Headache: Mild
|
13.5 Percentage of participants
Interval 11.5 to 15.8
|
14.5 Percentage of participants
Interval 12.3 to 16.8
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Headache: Moderate
|
7.5 Percentage of participants
Interval 6.0 to 9.4
|
8.2 Percentage of participants
Interval 6.6 to 10.1
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Headache: Severe
|
0.4 Percentage of participants
Interval 0.1 to 1.0
|
0.4 Percentage of participants
Interval 0.1 to 1.0
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Headache: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Joint pain: Mild
|
4.9 Percentage of participants
Interval 3.6 to 6.4
|
5.2 Percentage of participants
Interval 3.9 to 6.7
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Joint pain: Moderate
|
5.6 Percentage of participants
Interval 4.2 to 7.2
|
5.2 Percentage of participants
Interval 3.9 to 6.7
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Joint pain: Severe
|
0.6 Percentage of participants
Interval 0.2 to 1.3
|
0.1 Percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Joint pain: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Muscle pain: Mild
|
5.6 Percentage of participants
Interval 4.2 to 7.2
|
5.1 Percentage of participants
Interval 3.8 to 6.6
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Muscle pain: Moderate
|
6.5 Percentage of participants
Interval 5.0 to 8.2
|
7.4 Percentage of participants
Interval 5.8 to 9.2
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Muscle pain: Severe
|
1.0 Percentage of participants
Interval 0.5 to 1.9
|
0.5 Percentage of participants
Interval 0.2 to 1.2
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Muscle pain: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Vomiting: Mild
|
1.2 Percentage of participants
Interval 0.6 to 2.1
|
1.9 Percentage of participants
Interval 1.2 to 3.0
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Vomiting: Moderate
|
0.2 Percentage of participants
Interval 0.0 to 0.7
|
0.4 Percentage of participants
Interval 0.1 to 1.0
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Vomiting: Severe
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1
Vomiting: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
PRIMARY outcome
Timeframe: Up to 7 days after Dose 2 of investigational product at Month 1Population: Safety analysis set included all participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild (38.0 to 38.4 deg C), moderate (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C) and potentially life threatening (\>40.0 deg C). Fatigue, headache, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily routine activity and potentially life threatening: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: \>2 times in 24h, severe: required intravenous hydration and potentially life threatening: emergency room visit or hospitalization for hypotensive shock. The maximum severity was defined as highest grading of each systemic event through 7 days of vaccination.
Outcome measures
| Measure |
2-Dose Clostridium Difficile Vaccine
n=937 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
3-Dose Clostridium Difficile Vaccine
n=940 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
|---|---|---|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Fever: 38.0-38.4 deg C
|
0.6 Percentage of participants
Interval 0.2 to 1.4
|
0.3 Percentage of participants
Interval 0.1 to 0.9
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Fever: 38.5-38.9 deg C
|
0.3 Percentage of participants
Interval 0.1 to 0.9
|
0.3 Percentage of participants
Interval 0.1 to 0.9
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Fever: 39.0-40.0 deg C
|
0.1 Percentage of participants
Interval 0.0 to 0.6
|
0.2 Percentage of participants
Interval 0.0 to 0.8
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Fever: >40.0 deg C
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Fatigue: Mild
|
9.5 Percentage of participants
Interval 7.7 to 11.6
|
12.1 Percentage of participants
Interval 10.1 to 14.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Fatigue: Moderate
|
11.2 Percentage of participants
Interval 9.3 to 13.4
|
12.6 Percentage of participants
Interval 10.5 to 14.8
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Fatigue: Severe
|
1.3 Percentage of participants
Interval 0.7 to 2.2
|
1.6 Percentage of participants
Interval 0.9 to 2.6
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Fatigue: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Headache: Mild
|
9.8 Percentage of participants
Interval 8.0 to 11.9
|
10.9 Percentage of participants
Interval 8.9 to 13.0
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Headache: Moderate
|
6.1 Percentage of participants
Interval 4.6 to 7.8
|
7.8 Percentage of participants
Interval 6.1 to 9.7
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Headache: Severe
|
0.7 Percentage of participants
Interval 0.3 to 1.5
|
0.7 Percentage of participants
Interval 0.3 to 1.5
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Headache: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Joint pain: Mild
|
2.0 Percentage of participants
Interval 1.2 to 3.1
|
2.6 Percentage of participants
Interval 1.6 to 3.8
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Joint pain: Moderate
|
4.8 Percentage of participants
Interval 3.5 to 6.4
|
5.6 Percentage of participants
Interval 4.3 to 7.3
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Joint pain: Severe
|
0.6 Percentage of participants
Interval 0.2 to 1.4
|
1.0 Percentage of participants
Interval 0.4 to 1.8
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Joint pain: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Muscle pain: Mild
|
3.2 Percentage of participants
Interval 2.2 to 4.5
|
3.6 Percentage of participants
Interval 2.5 to 5.0
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Muscle pain: Moderate
|
5.2 Percentage of participants
Interval 3.9 to 6.9
|
7.7 Percentage of participants
Interval 6.0 to 9.5
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Muscle pain: Severe
|
0.6 Percentage of participants
Interval 0.2 to 1.4
|
0.7 Percentage of participants
Interval 0.3 to 1.5
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Muscle pain: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Vomiting: Mild
|
0.9 Percentage of participants
Interval 0.4 to 1.7
|
0.9 Percentage of participants
Interval 0.4 to 1.7
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Vomiting: Moderate
|
0.5 Percentage of participants
Interval 0.2 to 1.2
|
0.4 Percentage of participants
Interval 0.1 to 1.1
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Vomiting: Severe
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2
Vomiting: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
PRIMARY outcome
Timeframe: Up to 7 days after Dose 3 of investigational product at Month 6Population: Safety analysis set included all participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild (38.0 to 38.4 deg C), moderate (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C) and potentially life threatening (\>40.0 deg C). Fatigue, headache, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily routine activity and potentially life threatening: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: \>2 times in 24h, severe: required intravenous hydration and potentially life threatening: emergency room visit or hospitalization for hypotensive shock. The maximum severity was defined as highest grading of each systemic event through 7 days of vaccination.
Outcome measures
| Measure |
2-Dose Clostridium Difficile Vaccine
n=869 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
3-Dose Clostridium Difficile Vaccine
n=894 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
|---|---|---|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Muscle pain: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Vomiting: Severe
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Vomiting: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Fever: 38.0-38.4 deg C
|
0.3 Percentage of participants
Interval 0.1 to 1.0
|
0.1 Percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Fever: 38.5-38.9 deg C
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.1 Percentage of participants
Interval 0.0 to 0.6
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Fever: 39.0-40.0 deg C
|
0.3 Percentage of participants
Interval 0.1 to 1.0
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Fever: >40.0 deg C
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Fatigue: Mild
|
9.1 Percentage of participants
Interval 7.3 to 11.2
|
9.6 Percentage of participants
Interval 7.8 to 11.7
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Fatigue: Moderate
|
11.3 Percentage of participants
Interval 9.3 to 13.6
|
13.1 Percentage of participants
Interval 10.9 to 15.5
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Fatigue: Severe
|
1.6 Percentage of participants
Interval 0.9 to 2.7
|
0.9 Percentage of participants
Interval 0.4 to 1.8
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Fatigue: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Headache: Mild
|
11.5 Percentage of participants
Interval 9.5 to 13.8
|
12.8 Percentage of participants
Interval 10.6 to 15.1
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Headache: Moderate
|
7.6 Percentage of participants
Interval 5.9 to 9.6
|
5.1 Percentage of participants
Interval 3.8 to 6.8
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Headache: Severe
|
0.7 Percentage of participants
Interval 0.3 to 1.5
|
0.7 Percentage of participants
Interval 0.2 to 1.5
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Headache: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Joint pain: Mild
|
2.9 Percentage of participants
Interval 1.9 to 4.2
|
2.6 Percentage of participants
Interval 1.6 to 3.8
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Joint pain: Moderate
|
5.2 Percentage of participants
Interval 3.8 to 6.9
|
3.6 Percentage of participants
Interval 2.5 to 5.0
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Joint pain: Severe
|
0.3 Percentage of participants
Interval 0.1 to 1.0
|
0.2 Percentage of participants
Interval 0.0 to 0.8
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Joint pain: Potentially life threatening
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
0.0 Percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Muscle pain: Mild
|
5.5 Percentage of participants
Interval 4.1 to 7.3
|
4.8 Percentage of participants
Interval 3.5 to 6.4
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Muscle pain: Moderate
|
6.2 Percentage of participants
Interval 4.7 to 8.0
|
4.9 Percentage of participants
Interval 3.6 to 6.6
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Muscle pain: Severe
|
0.1 Percentage of participants
Interval 0.0 to 0.6
|
0.3 Percentage of participants
Interval 0.1 to 1.0
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Vomiting: Mild
|
1.2 Percentage of participants
Interval 0.6 to 2.1
|
1.5 Percentage of participants
Interval 0.8 to 2.5
|
|
Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3
Vomiting: Moderate
|
0.5 Percentage of participants
Interval 0.1 to 1.2
|
0.2 Percentage of participants
Interval 0.0 to 0.8
|
PRIMARY outcome
Timeframe: From day of first dose up to 1 month after last dose (up to Month 7)Population: Safety analysis set included all participants who received at least 1 dose of the investigational product.
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Percentage of participants with any AEs (both serious and all non-serious AEs) and non-serious AEs through 1 month after last study vaccination were reported in this outcome measure. Only AEs and non-SAEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
2-Dose Clostridium Difficile Vaccine
n=994 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
3-Dose Clostridium Difficile Vaccine
n=997 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
|---|---|---|
|
Percentage of Participants With Adverse Events Through 1 Month After Last Study Vaccination
Any AEs
|
47.7 Percentage of participants
|
49.7 Percentage of participants
|
|
Percentage of Participants With Adverse Events Through 1 Month After Last Study Vaccination
Non-Serious AEs
|
44.8 Percentage of participants
|
46.8 Percentage of participants
|
PRIMARY outcome
Timeframe: From day of first dose up to 6 months after last dose (up to Month 12)Population: Safety analysis set included all participants who received at least 1 dose of the investigational product.
SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
2-Dose Clostridium Difficile Vaccine
n=994 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
3-Dose Clostridium Difficile Vaccine
n=997 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) Through 6 Months After Last Study Vaccination
|
14.2 Percentage of participants
|
13.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Month 12Population: EI12 population. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies participants with valid and determinate assay results for the specified assay at both baseline and the given sampling time point.
Adjusted GMCs and 2-sided 95% CIs of toxin A and toxin B specific neutralizing antibody levels were calculated by exponentiating the LS means and the corresponding CIs based on analysis of logarithmically transformed concentrations using a linear regression model with terms of baseline concentration (log scale) and vaccine group. EI12: all enrolled participants who received all 3 doses of investigational product; had blood drawn for assay testing within 165 to 200 days after visit 4; had valid and determinate assay results for either toxin A or B for the specified analysis at Month 12; had no major protocol deviations.
Outcome measures
| Measure |
2-Dose Clostridium Difficile Vaccine
n=801 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
3-Dose Clostridium Difficile Vaccine
n=825 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
|---|---|---|
|
Adjusted Geometric Mean Concentration for Clostridium Difficile Toxin A and Toxin B Specific Neutralizing Antibody at Month 12 for EIP
Toxin A
|
327.5 Neutralization units per milliliter
Interval 307.9 to 348.3
|
375.5 Neutralization units per milliliter
Interval 353.4 to 399.1
|
|
Adjusted Geometric Mean Concentration for Clostridium Difficile Toxin A and Toxin B Specific Neutralizing Antibody at Month 12 for EIP
Toxin B
|
2230.8 Neutralization units per milliliter
Interval 2033.9 to 2446.7
|
3149.8 Neutralization units per milliliter
Interval 2875.5 to 3450.1
|
SECONDARY outcome
Timeframe: Month 12Population: EI12 population. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies participants with valid and determinate assay results for the specified assay at both baseline and the given sampling time point.
Seroresponse was defined as at least a 4-fold rise from the baseline neutralizing antibody following vaccination. 95% CI was based on Clopper-Pearson method. EI12: all enrolled participants who received all 3 doses of investigational product; had blood drawn for assay testing within 165 to 200 days after visit 4; had valid and determinate assay results for either toxin A or B for the specified analysis at Month 12; had no major protocol deviations.
Outcome measures
| Measure |
2-Dose Clostridium Difficile Vaccine
n=801 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
3-Dose Clostridium Difficile Vaccine
n=825 Participants
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
|---|---|---|
|
Percentage of Participants Achieving Seroresponse for Clostridium Difficile Toxin A and Toxin B at Month 12 for EIP
Toxin A
|
7.8 Percentage of participants
Interval 6.0 to 9.8
|
8.8 Percentage of participants
Interval 6.9 to 10.9
|
|
Percentage of Participants Achieving Seroresponse for Clostridium Difficile Toxin A and Toxin B at Month 12 for EIP
Toxin B
|
40.0 Percentage of participants
Interval 36.5 to 43.4
|
50.2 Percentage of participants
Interval 46.8 to 53.7
|
Adverse Events
2-Dose Clostridium Difficile Vaccine
Serious events: 141 serious events
Other events: 721 other events
Deaths: 15 deaths
3-Dose Clostridium Difficile Vaccine
Serious events: 136 serious events
Other events: 751 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
2-Dose Clostridium Difficile Vaccine
n=994 participants at risk
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
3-Dose Clostridium Difficile Vaccine
n=997 participants at risk
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.40%
4/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Cardiac disorders
Angina unstable
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Cardiac disorders
Atrial fibrillation
|
0.70%
7/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.30%
3/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Cardiac disorders
Bradycardia
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.20%
2/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Cardiac disorders
Cardiac arrest
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.60%
6/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.80%
8/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Cardiac disorders
Cardiogenic shock
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Cardiac disorders
Cardiomegaly
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Cardiac disorders
Coronary artery disease
|
0.50%
5/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.20%
2/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Cardiac disorders
Myocardial infarction
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Congenital, familial and genetic disorders
Familial amyloidosis
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.20%
2/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Duodenal vascular ectasia
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Gastritis
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Haematemesis
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Nausea
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.20%
2/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.30%
3/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
General disorders
Asthenia
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
General disorders
Chest pain
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.80%
8/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
General disorders
Death
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.20%
2/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Hepatobiliary disorders
Cholangitis
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Bronchitis
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
COVID-19
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.30%
3/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Cellulitis
|
0.40%
4/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.90%
9/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Clostridium difficile infection
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Diverticulitis
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.20%
2/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Epididymitis
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Escherichia infection
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Herpes zoster
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Influenza
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Metapneumovirus pneumonia
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Pneumonia
|
0.40%
4/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
1.0%
10/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Pneumonia bacterial
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Pneumonia influenzal
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Pneumonia viral
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Pyelonephritis acute
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Sepsis
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.70%
7/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Septic shock
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.30%
3/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Urinary tract infection
|
0.40%
4/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.40%
4/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Urosepsis
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.20%
2/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Fall
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.20%
2/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Gastrointestinal procedural complication
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Post procedural hypotension
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.30%
3/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.30%
3/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.20%
2/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer stage I
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.20%
2/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Bell's palsy
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Brain injury
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.30%
3/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.30%
3/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Intracranial mass
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Ischaemic stroke
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.20%
2/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Lacunar infarction
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.30%
3/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Nerve compression
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Presyncope
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Seizure
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.20%
2/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Somnolence
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Syncope
|
0.60%
6/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Transient global amnesia
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.30%
3/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Tremor
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Product Issues
Device dislocation
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Product Issues
Device occlusion
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Psychiatric disorders
Behaviour disorder
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Psychiatric disorders
Depression
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.20%
2/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Psychiatric disorders
Homicidal ideation
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Psychiatric disorders
Mental status changes
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Psychiatric disorders
Suicidal behaviour
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.20%
2/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.70%
7/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Renal and urinary disorders
Hypertensive nephropathy
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Renal and urinary disorders
Renal failure
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Renal and urinary disorders
Renal tubular acidosis
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.60%
6/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.80%
8/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.70%
7/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.20%
2/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.20%
2/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.40%
4/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Surgical and medical procedures
Multiple drug therapy
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Surgical and medical procedures
Oesophagogastric fundoplasty
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Vascular disorders
Aortic stenosis
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Vascular disorders
Deep vein thrombosis
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.30%
3/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Vascular disorders
Hypertension
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Vascular disorders
Hypotension
|
0.20%
2/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.00%
0/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Vascular disorders
Shock
|
0.10%
1/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.10%
1/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
Other adverse events
| Measure |
2-Dose Clostridium Difficile Vaccine
n=994 participants at risk
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
3-Dose Clostridium Difficile Vaccine
n=997 participants at risk
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
18/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
2.1%
21/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
12/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
1.4%
14/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Gastrointestinal disorders
Vomiting (VOMITING)
|
3.7%
37/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
4.5%
45/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
General disorders
Fatigue
|
1.3%
13/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.50%
5/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
General disorders
Fatigue (FATIGUE)
|
42.9%
426/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
46.2%
461/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
General disorders
Injection site erythema (REDNESS)
|
5.3%
53/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
8.5%
85/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
General disorders
Injection site pain (PAIN)
|
38.0%
378/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
44.1%
440/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
General disorders
Injection site swelling (SWELLING)
|
8.0%
80/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
12.9%
129/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
General disorders
Pyrexia (FEVER)
|
2.3%
23/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
1.9%
19/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Bronchitis
|
1.9%
19/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
0.90%
9/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Cellulitis
|
1.2%
12/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
1.2%
12/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
15/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
1.8%
18/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Sinusitis
|
2.0%
20/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
2.5%
25/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.4%
44/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
4.0%
40/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
38/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
4.1%
41/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Injury, poisoning and procedural complications
Fall
|
3.8%
38/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
3.8%
38/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.3%
23/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
2.4%
24/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
19.3%
192/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
18.4%
183/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
15/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
1.4%
14/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
23.4%
233/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
24.6%
245/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Headache
|
0.80%
8/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
1.8%
18/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Nervous system disorders
Headache (HEADACHE)
|
36.1%
359/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
38.9%
388/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
|
Vascular disorders
Hypertension
|
1.1%
11/994 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
1.4%
14/997 • Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
|
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