Trial Outcomes & Findings for Immunogenicity and Safety Study of Infanrix Hexa in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery (NCT NCT02422264)
NCT ID: NCT02422264
Last Updated: 2019-07-09
Results Overview
Vaccine response to the PT, FHA and PRN antigens, is defined as the appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations lower than (\<) the cut-off value of the assay), or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations greater than or equal to (≥) the cut-off value of the assay). Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, 2.187 IU/mL for anti-PRN.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
601 participants
Primary outcome timeframe
1 month after the last dose of the primary vaccination
Results posted on
2019-07-09
Participant Flow
Participant milestones
| Measure |
dTpa Group
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Overall Study
STARTED
|
296
|
305
|
|
Overall Study
COMPLETED
|
291
|
301
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
dTpa Group
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Overall Study
Serious Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Migrated/moved from study area
|
3
|
1
|
|
Overall Study
Subject vaccinated outside of the study
|
0
|
1
|
Baseline Characteristics
Immunogenicity and Safety Study of Infanrix Hexa in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
Baseline characteristics by cohort
| Measure |
dTpa Group
n=296 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=305 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Total
n=601 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.7 Weeks
STANDARD_DEVIATION 1.6 • n=99 Participants
|
8.9 Weeks
STANDARD_DEVIATION 1.8 • n=107 Participants
|
8.8 Weeks
STANDARD_DEVIATION 1.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=99 Participants
|
144 Participants
n=107 Participants
|
285 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
155 Participants
n=99 Participants
|
161 Participants
n=107 Participants
|
316 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African Heritage / African American
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White - Arabic / North African Heritage
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian / European Heritage
|
268 Participants
n=99 Participants
|
285 Participants
n=107 Participants
|
553 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Mixed origin
|
18 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 month after the last dose of the primary vaccinationPopulation: The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the Totally vaccinated cohort (TVC) who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component
Vaccine response to the PT, FHA and PRN antigens, is defined as the appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations lower than (\<) the cut-off value of the assay), or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations greater than or equal to (≥) the cut-off value of the assay). Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, 2.187 IU/mL for anti-PRN.
Outcome measures
| Measure |
dTpa Group
n=240 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=251 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Number of Subjects With Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens
anti-PT antibody
|
185 Participants
|
249 Participants
|
|
Number of Subjects With Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens
anti-FHA antibody
|
95 Participants
|
238 Participants
|
|
Number of Subjects With Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens
anti-PRN antibody
|
90 Participants
|
225 Participants
|
PRIMARY outcome
Timeframe: 1 month after the last dose of the primary vaccinationPopulation: The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.
A seroprotected subject is a subject whose antibody concentration/titre was ≥ the level defining clinical protection, of 0.1 International Units per milliliter (IU/mL).
Outcome measures
| Measure |
dTpa Group
n=266 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=271 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off
anti-D antibody
|
264 Participants
|
271 Participants
|
|
Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off
anti-T antibody
|
266 Participants
|
271 Participants
|
PRIMARY outcome
Timeframe: 1 month after the last dose of the primary vaccinationPopulation: The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.
A seroprotected subject is a subject whose antibody concentration/titre was ≥ to the level defining clinical protection, of 10 micro International Units per milliliter (mIU/mL).
Outcome measures
| Measure |
dTpa Group
n=253 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=263 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Number of Seroprotected Subjects With Anti Hepatitis B (Anti-HBs) Antibody Concentration Above or Equal to the Assay Cut-off
|
251 Participants
|
259 Participants
|
PRIMARY outcome
Timeframe: 1 month after the last dose of the primary vaccinationPopulation: The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.
A seroprotected subject is a subject whose antibody titre was ≥ the level defining clinical protection, of 8 ED50.
Outcome measures
| Measure |
dTpa Group
n=241 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=245 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Number of Seroprotected Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentration Above or Equal to 8
anti-Polio 1 antibody
|
233 Participants
|
242 Participants
|
|
Number of Seroprotected Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentration Above or Equal to 8
anti-Polio 2 antibody
|
239 Participants
|
235 Participants
|
|
Number of Seroprotected Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentration Above or Equal to 8
anti-Polio 3 antibody
|
228 Participants
|
236 Participants
|
PRIMARY outcome
Timeframe: 1 month after the last dose of the primary vaccinationPopulation: The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.
A seroprotected subject is a subject whose antibody concentration/titre was ≥ the level defining clinical protection, of 0.15 micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
dTpa Group
n=266 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=271 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Number of Seroprotected Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Above or Equal to the Assay Cut-off
|
255 Participants
|
256 Participants
|
SECONDARY outcome
Timeframe: Before the first dose of Infanrix hexaPopulation: The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.
A seroprotected subject is a subject whose antibody concentration was ≥ the level defining clinical protection, of 0.1 IU/mL.
Outcome measures
| Measure |
dTpa Group
n=242 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=253 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off.
anti-D antibody
|
200 Participants
|
110 Participants
|
|
Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off.
anti-T antibody
|
240 Participants
|
225 Participants
|
SECONDARY outcome
Timeframe: Before the first dose of Infanrix hexaPopulation: The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.
Antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in IU/mL.
Outcome measures
| Measure |
dTpa Group
n=242 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=253 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Anti-D and Anti-T Antibody Concentrations
anti-D antibody
|
0.423 IU/mL
Interval 0.354 to 0.506
|
0.089 IU/mL
Interval 0.076 to 0.103
|
|
Anti-D and Anti-T Antibody Concentrations
anti-T antibody
|
2.152 IU/mL
Interval 1.925 to 2.406
|
0.378 IU/mL
Interval 0.33 to 0.434
|
SECONDARY outcome
Timeframe: Before the first dose of Infanrix hexaPopulation: The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.
A seropositive subject is a subject whose antibody concentration is ≥ the assay cut-off defined. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA,2.187 IU/mL for anti-PRN
Outcome measures
| Measure |
dTpa Group
n=242 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=253 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off.
anti-PT antibody
|
218 Participants
|
88 Participants
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off.
anti-FHA antibody
|
242 Participants
|
210 Participants
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off.
anti-PRN antibody
|
231 Participants
|
151 Participants
|
SECONDARY outcome
Timeframe: Before the first dose of Infanrix hexaPopulation: The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.
Anti-PT, anti-FHA and anti-PRN antibody concentrations were expressed as GMCs and measured in IU/mL.
Outcome measures
| Measure |
dTpa Group
n=242 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=253 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
anti-PT antibody
|
11.9 IU/ml
Interval 10.3 to 13.6
|
2.2 IU/ml
Interval 2.0 to 2.5
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
anti-FHA antibody
|
88.3 IU/ml
Interval 77.7 to 100.4
|
6.6 IU/ml
Interval 5.7 to 7.7
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
anti-PRN antibody
|
70.5 IU/ml
Interval 56.1 to 88.5
|
4.5 IU/ml
Interval 3.7 to 5.4
|
SECONDARY outcome
Timeframe: 1 month after the last dose of the primary vaccinationPopulation: The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.
Antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in IU/mL.
Outcome measures
| Measure |
dTpa Group
n=266 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=271 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Anti-D and Anti-T Antibody Concentrations
anti-D antibody
|
1.747 IU/ml
Interval 1.598 to 1.91
|
2.746 IU/ml
Interval 2.502 to 3.015
|
|
Anti-D and Anti-T Antibody Concentrations
anti-T antibody
|
2.347 IU/ml
Interval 2.135 to 2.582
|
2.278 IU/ml
Interval 2.069 to 2.508
|
SECONDARY outcome
Timeframe: 1 month after the last dose of the primary vaccinationPopulation: The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.
Anti-Polio type 1, 2 and 3 antibody titers were expressed as geometric mean titers (GMT).
Outcome measures
| Measure |
dTpa Group
n=241 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=245 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Anti-Polio Type 1, 2 and 3 Antibody Titers
anti-Polio 1 antibody
|
432.1 Titers
Interval 351.8 to 530.9
|
489.9 Titers
Interval 402.6 to 596.0
|
|
Anti-Polio Type 1, 2 and 3 Antibody Titers
anti-Polio 2 antibody
|
424.6 Titers
Interval 342.7 to 526.2
|
388.4 Titers
Interval 306.3 to 492.6
|
|
Anti-Polio Type 1, 2 and 3 Antibody Titers
anti-Polio 3 antibody
|
730.6 Titers
Interval 596.5 to 894.9
|
775.6 Titers
Interval 645.9 to 931.3
|
SECONDARY outcome
Timeframe: 1 month after the last dose of the primary vaccinationPopulation: The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.
Anti-HBs antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in mIU/mL.
Outcome measures
| Measure |
dTpa Group
n=253 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=263 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Anti-HBs Antibody Concentrations
|
1322.8 mIU/ml
Interval 1116.7 to 1567.0
|
1339.2 mIU/ml
Interval 1132.8 to 1583.3
|
SECONDARY outcome
Timeframe: 1 month after the last dose of the primary vaccinationPopulation: The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.
Anti-PRP antibody concentrations were expressed as GMCs and measured in µg/mL.
Outcome measures
| Measure |
dTpa Group
n=266 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=271 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Anti-PRP Antibody Concentrations
|
1.862 µg/mL
Interval 1.554 to 2.231
|
1.717 µg/mL
Interval 1.428 to 2.064
|
SECONDARY outcome
Timeframe: 1 month after the last dose of the primary vaccinationPopulation: The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.
Anti-PT, anti-FHA, anti-PRN antibody concentrations were expressed as GMCs and measured in IU/mL.
Outcome measures
| Measure |
dTpa Group
n=266 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=271 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
anti-PT antibody
|
32.7 IU/mL
Interval 30.2 to 35.3
|
54.7 IU/mL
Interval 51.0 to 58.6
|
|
Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
anti-FHA antibody
|
68.5 IU/mL
Interval 63.5 to 73.9
|
103.5 IU/mL
Interval 95.6 to 112.1
|
|
Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
anti-PRN antibody
|
60.5 IU/mL
Interval 54.2 to 67.6
|
92.0 IU/mL
Interval 81.6 to 103.6
|
SECONDARY outcome
Timeframe: 1 month after the last dose of the primary vaccinationPopulation: The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.
Assessed anti-pneumococcal serotypes were (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F), expressed as GMCs and measured in µg/mL.
Outcome measures
| Measure |
dTpa Group
n=232 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=237 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Anti-pneumococcal Antibody Concentrations
anti-PnPS 23F antibody
|
0.86 µg/mL
Interval 0.74 to 0.99
|
1.02 µg/mL
Interval 0.88 to 1.17
|
|
Anti-pneumococcal Antibody Concentrations
anti-PnPS 1 antibody
|
1.61 µg/mL
Interval 1.43 to 1.8
|
1.92 µg/mL
Interval 1.73 to 2.14
|
|
Anti-pneumococcal Antibody Concentrations
anti-PnPS 3 antibody
|
0.54 µg/mL
Interval 0.49 to 0.6
|
0.60 µg/mL
Interval 0.55 to 0.67
|
|
Anti-pneumococcal Antibody Concentrations
anti-PnPS 4 antibody
|
1.20 µg/mL
Interval 1.07 to 1.35
|
1.56 µg/mL
Interval 1.4 to 1.75
|
|
Anti-pneumococcal Antibody Concentrations
anti-PnPS 5 antibody
|
1.09 µg/mL
Interval 0.96 to 1.24
|
1.27 µg/mL
Interval 1.13 to 1.43
|
|
Anti-pneumococcal Antibody Concentrations
anti-PnPS 6A antibody
|
2.16 µg/mL
Interval 1.89 to 2.47
|
2.59 µg/mL
Interval 2.27 to 2.95
|
|
Anti-pneumococcal Antibody Concentrations
anti-PnPS 6B antibody
|
1.37 µg/mL
Interval 1.12 to 1.68
|
1.44 µg/mL
Interval 1.2 to 1.73
|
|
Anti-pneumococcal Antibody Concentrations
anti-PnPS 7F antibody
|
2.39 µg/mL
Interval 2.15 to 2.65
|
2.67 µg/mL
Interval 2.43 to 2.93
|
|
Anti-pneumococcal Antibody Concentrations
anti-PnPS 9V antibody
|
1.33 µg/mL
Interval 1.19 to 1.5
|
1.64 µg/mL
Interval 1.47 to 1.83
|
|
Anti-pneumococcal Antibody Concentrations
anti-PnPS 14 antibody
|
5.70 µg/mL
Interval 4.99 to 6.52
|
6.57 µg/mL
Interval 5.71 to 7.56
|
|
Anti-pneumococcal Antibody Concentrations
anti-PnPS 18C antibody
|
1.61 µg/mL
Interval 1.42 to 1.82
|
1.79 µg/mL
Interval 1.59 to 2.01
|
|
Anti-pneumococcal Antibody Concentrations
anti-PnPS 19A antibody
|
1.61 µg/mL
Interval 1.43 to 1.82
|
2.01 µg/mL
Interval 1.78 to 2.27
|
|
Anti-pneumococcal Antibody Concentrations
anti-PnPS 19F antibody
|
2.57 µg/mL
Interval 2.35 to 2.82
|
3.24 µg/mL
Interval 2.92 to 3.6
|
SECONDARY outcome
Timeframe: 1 month after the last dose of the primary vaccinationPopulation: The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.
A seropositive subject is a subject whose antibody concentration is ≥ the assay cut-off defined. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA,2.187 IU/mL for anti-PRN
Outcome measures
| Measure |
dTpa Group
n=266 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=271 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Number of Subjects With Anti-PT, Anti-FHA, Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off.
anti-FHA antibody
|
266 Participants
|
271 Participants
|
|
Number of Subjects With Anti-PT, Anti-FHA, Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off.
anti-PRN antibody
|
266 Participants
|
269 Participants
|
|
Number of Subjects With Anti-PT, Anti-FHA, Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off.
anti-PT antibody
|
266 Participants
|
271 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-Day 3) follow-up period after each vaccinationPopulation: The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and for those with at least 1 vaccine administration documented.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Solicited local symptoms were assessed by each and across dose.
Outcome measures
| Measure |
dTpa Group
n=294 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=303 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling, Across Doses
|
157 Participants
|
168 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Pain, Dose 1
|
120 Participants
|
120 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness, Dose 1
|
128 Participants
|
116 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling, Dose 1
|
81 Participants
|
87 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Pain, Dose 2
|
109 Participants
|
101 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness, Dose 2
|
139 Participants
|
139 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling, Dose 2
|
98 Participants
|
95 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Pain, Dose 3
|
85 Participants
|
94 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness, Dose 3
|
122 Participants
|
134 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling, Dose 3
|
77 Participants
|
109 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Pain, Across Doses
|
175 Participants
|
184 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness, Across Doses
|
205 Participants
|
203 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-Day 3) follow-up period after each vaccinationPopulation: The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and for those with at least 1 vaccine administration documented.
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and fever \[defined as axillary route temperature ≥ 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Solicited general symptoms were assessed by each and across dose.
Outcome measures
| Measure |
dTpa Group
n=294 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=303 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Number of Subjects With Solicited General Symptoms
Any Drowsiness, Dose 1
|
166 Participants
|
174 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Irritability / Fussiness, Dose 1
|
187 Participants
|
191 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Irritability / Fussiness, Dose 3
|
142 Participants
|
161 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Drowsiness, Across Doses
|
216 Participants
|
232 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Loss of Appetite, Dose 1
|
85 Participants
|
94 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Temperature/(Axillary) (≥37.5°C), Dose 1
|
64 Participants
|
69 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Drowsiness, Dose 2
|
142 Participants
|
149 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Irritability / Fussiness, Dose 2
|
182 Participants
|
194 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Loss of Appetite, Dose 2
|
69 Participants
|
94 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Temperature/(Axillary) (≥37.5°C), Dose 2
|
62 Participants
|
76 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Drowsiness, Dose 3
|
99 Participants
|
104 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Loss of Appetite, Dose 3
|
64 Participants
|
63 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Temperature/(Axillary) (≥37.5°C), Dose 3
|
52 Participants
|
47 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Irritability/Fussiness, Across Doses
|
255 Participants
|
257 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Loss of appetite, Across Doses
|
142 Participants
|
157 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Temperature/(Axillary) (≥37.5°C), Across Doses
|
125 Participants
|
126 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (days 0-30) follow-up period after each vaccinationPopulation: The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and for those with at least 1 vaccine administration documented.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
dTpa Group
n=296 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=305 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events
|
161 Participants
|
173 Participants
|
SECONDARY outcome
Timeframe: From Day 0, prior to vaccination until the study end, at Month 3 or 5 (depending on vaccination schedule of the country)Population: The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and for those with at least 1 vaccine administration documented.
SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Outcome measures
| Measure |
dTpa Group
n=296 Participants
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=305 Participants
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
7 Participants
|
17 Participants
|
Adverse Events
dTpa Group
Serious events: 7 serious events
Other events: 292 other events
Deaths: 0 deaths
Control Group
Serious events: 17 serious events
Other events: 294 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
dTpa Group
n=296 participants at risk
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=305 participants at risk
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Congenital cytomegalovirus infection
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Congenital, familial and genetic disorders
Craniosynostosis
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Congenital, familial and genetic disorders
Dandy-walker syndrome
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Congenital, familial and genetic disorders
Ear malformation
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Congenital, familial and genetic disorders
Microcephaly
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Immune system disorders
Milk allergy
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Bronchiolitis
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
1.3%
4/305 • Number of events 5 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Candida infection
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Superinfection bacterial
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Urinary tract infection
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Viral infection
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Nervous system disorders
Altered state of consciousness
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
Other adverse events
| Measure |
dTpa Group
n=296 participants at risk
Infants born to mothers belonging to the Boostrix Group in study NCT02377349 \[DTPA (BOOSTRIX)-047\] i.e. who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
Control Group
n=305 participants at risk
Infants born to mothers belonging to the Control group in study NCT02377349 \[DTPA (BOOSTRIX)-047\], i.e. who received a single dose of placebo during pregnancy and a dose of Boostrix immediately post-delivery. All infants in this group received Infanrix hexa co-administered with Prevenar 13 according to the routine national immunisation schedule.
|
|---|---|---|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Constipation
|
2.7%
8/296 • Number of events 9 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
3.0%
9/305 • Number of events 10 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
8/296 • Number of events 8 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.66%
2/305 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Flatulence
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.7%
8/296 • Number of events 8 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
2.0%
6/305 • Number of events 6 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Gingival pain
|
1.4%
4/296 • Number of events 5 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.98%
3/305 • Number of events 3 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Infantile colic
|
0.68%
2/296 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.66%
2/305 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Mucous stools
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Odynophagia
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Sandifer's syndrome
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Teething
|
4.7%
14/296 • Number of events 21 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
4.6%
14/305 • Number of events 16 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Congenital, familial and genetic disorders
Congenital torticollis
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Eye disorders
Dacryostenosis acquired
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.66%
2/305 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Eye disorders
Eye discharge
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.66%
2/305 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Eye disorders
Eye irritation
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Eye disorders
Eye swelling
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Eye disorders
Pupils unequal
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Toothache
|
0.68%
2/296 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
6/296 • Number of events 6 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
1.3%
4/305 • Number of events 4 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
General disorders
Influenza like illness
|
1.0%
3/296 • Number of events 3 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
General disorders
Injection site bruising
|
0.68%
2/296 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.66%
2/305 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
General disorders
Injection site induration
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
General disorders
Injection site mass
|
1.0%
3/296 • Number of events 4 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
General disorders
Injection site nodule
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
General disorders
Injection site swelling
|
53.0%
157/296 • Number of events 256 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
55.4%
169/305 • Number of events 292 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
General disorders
Pyrexia
|
44.9%
133/296 • Number of events 203 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
45.6%
139/305 • Number of events 208 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
General disorders
Thirst
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
General disorders
Vaccination site erythema
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.66%
2/305 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
General disorders
Vaccination site pain
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
General disorders
Vaccination site swelling
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Immune system disorders
Milk allergy
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.66%
2/305 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Adenoiditis
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Bronchiolitis
|
1.7%
5/296 • Number of events 5 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
3.6%
11/305 • Number of events 12 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Bronchitis
|
1.4%
4/296 • Number of events 4 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
1.6%
5/305 • Number of events 6 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Candida infection
|
0.68%
2/296 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Candida nappy rash
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Conjunctivitis
|
2.0%
6/296 • Number of events 6 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
4.3%
13/305 • Number of events 14 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Ear infection
|
2.0%
6/296 • Number of events 6 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
3.3%
10/305 • Number of events 12 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Erythema infectiosum
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Exanthema subitum
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.98%
3/305 • Number of events 3 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Eye infection
|
0.34%
1/296 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Fungal skin infection
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Furuncle
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Gastroenteritis
|
1.7%
5/296 • Number of events 5 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
2.6%
8/305 • Number of events 8 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Gastroenteritis viral
|
1.0%
3/296 • Number of events 3 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.66%
2/305 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Impetigo
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Influenza
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Laryngitis
|
1.0%
3/296 • Number of events 3 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.98%
3/305 • Number of events 3 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Nail infection
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Nasopharyngitis
|
6.8%
20/296 • Number of events 21 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
4.9%
15/305 • Number of events 17 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Oral candidiasis
|
1.4%
4/296 • Number of events 4 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.66%
2/305 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Otitis media
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.98%
3/305 • Number of events 3 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Otitis media acute
|
1.0%
3/296 • Number of events 3 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.66%
2/305 • Number of events 3 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Pharyngitis
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Respiratory tract infection
|
1.4%
4/296 • Number of events 5 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
3.0%
9/305 • Number of events 12 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Respiratory tract infection viral
|
1.4%
4/296 • Number of events 4 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
2.6%
8/305 • Number of events 8 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Rhinitis
|
0.68%
2/296 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
2.6%
8/305 • Number of events 8 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Tonsillitis
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.2%
36/296 • Number of events 41 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
10.5%
32/305 • Number of events 38 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
3/296 • Number of events 3 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.66%
2/305 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Varicella
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Viral infection
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Viral rash
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.66%
2/305 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Injury, poisoning and procedural complications
Bite
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.68%
2/296 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Investigations
Body temperature increased
|
0.68%
2/296 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.66%
2/305 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
48.0%
142/296 • Number of events 219 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
51.5%
157/305 • Number of events 252 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Musculoskeletal and connective tissue disorders
Head deformity
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Musculoskeletal and connective tissue disorders
Positional plagiocephaly
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.68%
2/296 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infantile haemangioma
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Nervous system disorders
Aphonia
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Nervous system disorders
External hydrocephalus
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Musculoskeletal and connective tissue disorders
Epiphysiolysis
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Psychiatric disorders
Irritability
|
0.68%
2/296 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.98%
3/305 • Number of events 3 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Reproductive system and breast disorders
Genital labial adhesions
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
6/296 • Number of events 6 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
4.3%
13/305 • Number of events 14 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
2.0%
6/305 • Number of events 6 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.0%
3/296 • Number of events 3 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
1.6%
5/305 • Number of events 5 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
2.6%
8/305 • Number of events 8 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.4%
4/296 • Number of events 4 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
2.0%
6/305 • Number of events 7 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
1.0%
3/296 • Number of events 3 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
1.3%
4/305 • Number of events 4 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.7%
5/296 • Number of events 5 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
1.6%
5/305 • Number of events 5 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
4/296 • Number of events 4 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
3.0%
9/305 • Number of events 9 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.66%
2/305 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.68%
2/296 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.66%
2/305 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.34%
1/296 • Number of events 2 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Vascular disorders
Pallor
|
0.00%
0/296 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.33%
1/305 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Vascular disorders
Peripheral coldness
|
0.34%
1/296 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
0.00%
0/305 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
General disorders
Injection site erythema
|
69.3%
205/296 • Number of events 389 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
66.6%
203/305 • Number of events 389 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
General disorders
Injection site pain
|
59.1%
175/296 • Number of events 314 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
60.3%
184/305 • Number of events 315 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
General disorders
Irritability postvaccinal
|
86.1%
255/296 • Number of events 511 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
84.3%
257/305 • Number of events 546 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
|
Nervous system disorders
Somnolence
|
73.0%
216/296 • Number of events 407 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
76.1%
232/305 • Number of events 427 • Solicited symptoms were collected during the 4-day (Day 0-Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (days 0-30) follow-up period after each vaccination. SAEs were collected from Day 0 to Month 3 or 5.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER