Trial Outcomes & Findings for Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014 (NCT NCT00614614)
NCT ID: NCT00614614
Last Updated: 2018-09-21
Results Overview
The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1558 participants
Primary outcome timeframe
One month post vaccination at 12-15 months of age (Month 11)
Results posted on
2018-09-21
Participant Flow
A total of 1558 subjects (1276 in the Menhibrix 1 Group and 282 in ActHIB- Infanrix Group) were enrolled; however, 4 of these subjects never received vaccine. Thus, 1554 subjects (1272 in the Menhibrix 1 Group and 282 in ActHIB- Infanrix Group) were vaccinated during primary vaccination phase.
Participant milestones
| Measure |
Menhibrix 1 Group
Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during the Primary Vaccination Phase. For the Booster Vaccination Phase, subjects were re-randomized and received either 1 dose of Nimenrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) \[Nimenrix 1 Group\] or a fourth dose of Menhibrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) \[Menhibrix 2 Group\], or 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine (at 15-18 months of age) \[Nimenrix 2 Group\].
|
ActHIB- Infanrix Group
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|---|
|
Primary Vaccination Phase
STARTED
|
1272
|
282
|
0
|
0
|
0
|
|
Primary Vaccination Phase
COMPLETED
|
1182
|
265
|
0
|
0
|
0
|
|
Primary Vaccination Phase
NOT COMPLETED
|
90
|
17
|
0
|
0
|
0
|
|
Booster Vaccination Phase
STARTED
|
0
|
233
|
432
|
229
|
409
|
|
Booster Vaccination Phase
COMPLETED
|
0
|
227
|
405
|
210
|
396
|
|
Booster Vaccination Phase
NOT COMPLETED
|
0
|
6
|
27
|
19
|
13
|
Reasons for withdrawal
| Measure |
Menhibrix 1 Group
Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during the Primary Vaccination Phase. For the Booster Vaccination Phase, subjects were re-randomized and received either 1 dose of Nimenrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) \[Nimenrix 1 Group\] or a fourth dose of Menhibrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) \[Menhibrix 2 Group\], or 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine (at 15-18 months of age) \[Nimenrix 2 Group\].
|
ActHIB- Infanrix Group
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|---|
|
Primary Vaccination Phase
Adverse Event
|
6
|
0
|
0
|
0
|
0
|
|
Primary Vaccination Phase
Withdrawal by Subject
|
45
|
6
|
0
|
0
|
0
|
|
Primary Vaccination Phase
Lost to Follow-up
|
26
|
8
|
0
|
0
|
0
|
|
Primary Vaccination Phase
Protocol Violation
|
9
|
3
|
0
|
0
|
0
|
|
Primary Vaccination Phase
Other
|
4
|
0
|
0
|
0
|
0
|
|
Booster Vaccination Phase
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
|
Booster Vaccination Phase
Withdrawal by Subject
|
0
|
0
|
4
|
3
|
4
|
|
Booster Vaccination Phase
Lost to Follow-up
|
0
|
5
|
17
|
10
|
8
|
|
Booster Vaccination Phase
Protocol Violation
|
0
|
0
|
2
|
3
|
0
|
|
Booster Vaccination Phase
Other
|
0
|
1
|
3
|
2
|
1
|
Baseline Characteristics
Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014
Baseline characteristics by cohort
| Measure |
Menhibrix 1 Group
n=1272 Participants
Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
|
ActHIB- Infanrix Group
n=282 Participants
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Total
n=1554 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.6 Weeks
STANDARD_DEVIATION 1.25 • n=5 Participants
|
8.7 Weeks
STANDARD_DEVIATION 1.25 • n=7 Participants
|
8.6 Weeks
STANDARD_DEVIATION 1.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
606 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
756 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
666 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
798 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African heritage / African American
|
135 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan native
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian heritage
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian heritage
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese heritage
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian heritage
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic / North African heritage
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian / European heritage
|
974 Participants
n=5 Participants
|
223 Participants
n=7 Participants
|
1197 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unspecified
|
127 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One month post vaccination at 12-15 months of age (Month 11)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.
The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Outcome measures
| Measure |
ActHIB- Infanrix Group
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=291 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group
hSBA-MenA
|
—
|
254 Participants
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group
hSBA-MenC
|
—
|
286 Participants
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group
hSBA-MenW-135
|
—
|
270 Participants
|
—
|
—
|
|
Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group
hSBA-MenY
|
—
|
291 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: One month post vaccination at 15-18 months of age (Month 14)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.
The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Outcome measures
| Measure |
ActHIB- Infanrix Group
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=303 Participants
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group
hSBA-MenA
|
—
|
—
|
—
|
248 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group
hSBA-MenC
|
—
|
—
|
—
|
293 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group
hSBA-MenW-135
|
—
|
—
|
—
|
279 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group
hSBA-MenY
|
—
|
—
|
—
|
303 Participants
|
PRIMARY outcome
Timeframe: One month post vaccination at 12-15 months of age (Month 11)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.
Antibody titers were expressed as Geometric mean titers (GMTs)
Outcome measures
| Measure |
ActHIB- Infanrix Group
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=291 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group
hSBA-MenY
|
—
|
4800.9 titer
Interval 4162.0 to 5537.9
|
—
|
—
|
|
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group
hSBA-MenC
|
—
|
3845.0 titer
Interval 3310.8 to 4465.4
|
—
|
—
|
PRIMARY outcome
Timeframe: One month post vaccination at 15-18 months of age (Month 14)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.
Antibody titers were expressed as Geometric mean titers (GMTs)
Outcome measures
| Measure |
ActHIB- Infanrix Group
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=303 Participants
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group
hSBA-MenC
|
—
|
—
|
—
|
7230.5 titer
Interval 6244.1 to 8372.8
|
|
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group
hSBA-MenY
|
—
|
—
|
—
|
7487.6 titer
Interval 6604.4 to 8488.9
|
PRIMARY outcome
Timeframe: One month post vaccination at 15-18 months of age (Month 14)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. It was performed on the Nimenrix 2 and ActHIB- Infanrix Group.
The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).
Outcome measures
| Measure |
ActHIB- Infanrix Group
n=146 Participants
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=254 Participants
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group
Anti-D
|
146 Participants
|
—
|
—
|
253 Participants
|
|
Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group
Anti-T
|
145 Participants
|
—
|
—
|
253 Participants
|
PRIMARY outcome
Timeframe: One month post vaccination at 12-15 months of age (Month 11)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Menhibrix 2 Group.
Antibody titers were expressed as Geometric mean titers (GMTs)
Outcome measures
| Measure |
ActHIB- Infanrix Group
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
n=157 Participants
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group
hSBA-MenC
|
—
|
—
|
2676.1 titer
Interval 2131.8 to 3359.5
|
—
|
|
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group
hSBA-MenY
|
—
|
—
|
2227.7 titer
Interval 1881.9 to 2637.0
|
—
|
PRIMARY outcome
Timeframe: One month post vaccination at 12-15 months of age (Month 11)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Menhibrix 2 Group.
The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Outcome measures
| Measure |
ActHIB- Infanrix Group
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
n=157 Participants
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Menhibrix 2 Group
hSBA-MenC
|
—
|
—
|
155 Participants
|
—
|
|
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Menhibrix 2 Group
hSBA-MenY
|
—
|
—
|
157 Participants
|
—
|
PRIMARY outcome
Timeframe: One month after vaccination at 15-18 months of age (Month 14)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on Nimenrix 2 and ActHIB- Infanrix Group.
Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)
Outcome measures
| Measure |
ActHIB- Infanrix Group
n=146 Participants
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=254 Participants
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group
Anti-PT
|
91.0 EL.U/mL
Interval 81.7 to 101.4
|
—
|
—
|
67.7 EL.U/mL
Interval 62.0 to 73.9
|
|
Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group
Anti-FHA
|
422.9 EL.U/mL
Interval 369.0 to 484.6
|
—
|
—
|
353.2 EL.U/mL
Interval 320.8 to 388.9
|
|
Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group
Anti-PRN
|
315.1 EL.U/mL
Interval 274.2 to 362.1
|
—
|
—
|
189.2 EL.U/mL
Interval 167.2 to 214.1
|
SECONDARY outcome
Timeframe: One month after vaccination at 12-15 months of age (Month 11)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.
The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4
Outcome measures
| Measure |
ActHIB- Infanrix Group
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=291 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
n=157 Participants
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group
hSBA-MenC
|
—
|
286 Participants
|
155 Participants
|
—
|
|
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group
hSBA-MenY
|
—
|
291 Participants
|
157 Participants
|
—
|
SECONDARY outcome
Timeframe: One month after vaccination at 12-15 months of age (Month 11)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.
The cut-off values assessed for hSBA-MenA and hSBA-MenW-135 were greater than or equal to (≥) 1:4
Outcome measures
| Measure |
ActHIB- Infanrix Group
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=273 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects With hSBA-MenA and hSBA MenW-135 Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group
hSBA-MenA
|
—
|
256 Participants
|
—
|
—
|
|
Number of Subjects With hSBA-MenA and hSBA MenW-135 Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group
hSBA-MenW-135
|
—
|
270 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after vaccination at 12-15 months of age (Month 11)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.
Antibody titers were expressed as Geometric mean titers (GMTs)
Outcome measures
| Measure |
ActHIB- Infanrix Group
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=273 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group
hSBA-MenA
|
—
|
94.8 titer
Interval 84.1 to 106.9
|
—
|
—
|
|
Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group
hSBA-MenW-135
|
—
|
923.9 titer
Interval 776.0 to 1099.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to vaccination at 15-18 months of age (Month 13)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.
Antibody titers were expressed as Geometric mean titers (GMTs)
Outcome measures
| Measure |
ActHIB- Infanrix Group
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=268 Participants
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group
hSBA-Men C
|
—
|
—
|
—
|
67.6 titer
Interval 55.5 to 82.3
|
|
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group
hSBA-MenY
|
—
|
—
|
—
|
142.3 titer
Interval 121.1 to 167.2
|
SECONDARY outcome
Timeframe: Prior to vaccination at 15-18 months of age (Month 13)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.
The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4 and ≥ 1:8
Outcome measures
| Measure |
ActHIB- Infanrix Group
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=268 Participants
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group
hSBA-MenC ≥ 1:4
|
—
|
—
|
—
|
243 Participants
|
|
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group
hSBA-MenC ≥ 1:8
|
—
|
—
|
—
|
241 Participants
|
|
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group
hSBA-MenY ≥ 1:4
|
—
|
—
|
—
|
258 Participants
|
|
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group
hSBA-MenY ≥ 1:8
|
—
|
—
|
—
|
258 Participants
|
SECONDARY outcome
Timeframe: One month after vaccination with Infanrix at 15-18 months of age (Month 14)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination.
Concentrations were provided as Geometric Mean Concentrations(GMCs) and expressed as International Units per milliliter (IU/mL).
Outcome measures
| Measure |
ActHIB- Infanrix Group
n=146 Participants
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=252 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
n=132 Participants
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=254 Participants
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Anti-D and Anti-T Geometric Mean Antibody Concentrations
Anti-D
|
8.259 IU/mL
Interval 7.347 to 9.285
|
7.214 IU/mL
Interval 6.592 to 7.895
|
7.360 IU/mL
Interval 6.508 to 8.323
|
7.458 IU/mL
Interval 6.82 to 8.155
|
|
Anti-D and Anti-T Geometric Mean Antibody Concentrations
Anti-T
|
5.500 IU/mL
Interval 4.877 to 6.204
|
7.400 IU/mL
Interval 6.9 to 7.936
|
8.458 IU/mL
Interval 7.762 to 9.215
|
11.751 IU/mL
Interval 10.818 to 12.765
|
SECONDARY outcome
Timeframe: One month after vaccination with Infanrix at 15-18 months of age (Month 14)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination.
The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL).
Outcome measures
| Measure |
ActHIB- Infanrix Group
n=146 Participants
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=252 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
n=132 Participants
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=254 Participants
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value
Anti-D
|
146 Participants
|
252 Participants
|
132 Participants
|
254 Participants
|
|
Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value
Anti-T
|
146 Participants
|
252 Participants
|
132 Participants
|
253 Participants
|
SECONDARY outcome
Timeframe: One month after vaccination with Infanrix at 15-18 months of age (Month 14)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination.
The cut-off values assessed were greater than or equal to (≥) 5 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)
Outcome measures
| Measure |
ActHIB- Infanrix Group
n=146 Participants
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=252 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
n=132 Participants
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=254 Participants
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value
Anti-PT
|
146 Participants
|
252 Participants
|
130 Participants
|
254 Participants
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value
Anti-FHA
|
146 Participants
|
252 Participants
|
132 Participants
|
253 Participants
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value
Anti-PRN
|
146 Participants
|
251 Participants
|
132 Participants
|
253 Participants
|
SECONDARY outcome
Timeframe: One month after vaccination at 15-18 months of age (Month 14)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.
Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)
Outcome measures
| Measure |
ActHIB- Infanrix Group
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=252 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
n=132 Participants
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group
Anti-PT
|
—
|
73.3 EL.U/mL
Interval 66.7 to 80.5
|
86.9 EL.U/mL
Interval 75.7 to 99.8
|
—
|
|
Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group
Anti-FHA
|
—
|
321.6 EL.U/mL
Interval 289.9 to 356.7
|
371.7 EL.U/mL
Interval 321.5 to 429.7
|
—
|
|
Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group
Anti-PRN
|
—
|
203.8 EL.U/mL
Interval 178.7 to 232.5
|
220.2 EL.U/mL
Interval 183.7 to 264.0
|
—
|
SECONDARY outcome
Timeframe: One month after vaccination at 15-18 months of age (Month 14)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.
The cut-off values assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).
Outcome measures
| Measure |
ActHIB- Infanrix Group
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=252 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
n=132 Participants
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group
Anti-D
|
—
|
250 Participants
|
132 Participants
|
—
|
|
Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group
Anti-T
|
—
|
250 Participants
|
132 Participants
|
—
|
SECONDARY outcome
Timeframe: One month after vaccination at 15-18 months of age (Month 14)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.
The cut-off values assessed for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY were greater than or equal to (≥) 1:4
Outcome measures
| Measure |
ActHIB- Infanrix Group
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=303 Participants
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group
hSBA-MenA
|
—
|
—
|
—
|
253 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group
hSBA-MenC
|
—
|
—
|
—
|
293 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group
hSBA-MenW-135
|
—
|
—
|
—
|
279 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group
hSBA-MenY
|
—
|
—
|
—
|
303 Participants
|
SECONDARY outcome
Timeframe: One month after vaccination with Infanrix at 15-18 months of age (Month 14)Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.
Antibody titers were expressed as Geometric mean titers (GMTs)
Outcome measures
| Measure |
ActHIB- Infanrix Group
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=283 Participants
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Geometric Mean Antibody Titers for hSBA-MenA and hSBA-MenW-135 in Nimenrix 2 Group
hSBA-MenA
|
—
|
—
|
—
|
92.4 titer
Interval 80.6 to 105.9
|
|
Geometric Mean Antibody Titers for hSBA-MenA and hSBA-MenW-135 in Nimenrix 2 Group
hSBA-MenW-135
|
—
|
—
|
—
|
1582.9 titer
Interval 1321.8 to 1895.5
|
SECONDARY outcome
Timeframe: During the 8-day follow-up period (Day 0-7) after vaccination in the booster phasePopulation: The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed.
Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was greater than (\>) 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful.
Outcome measures
| Measure |
ActHIB- Infanrix Group
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=408 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
n=217 Participants
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=386 Participants
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine
Any pain
|
—
|
156 Participants
|
104 Participants
|
170 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine
Grade 3 pain
|
—
|
7 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine
Any redness
|
—
|
171 Participants
|
90 Participants
|
169 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine
Grade 3 redness
|
—
|
3 Participants
|
1 Participants
|
5 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine
Any swelling
|
—
|
97 Participants
|
54 Participants
|
105 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine
Grade 3 swelling
|
—
|
3 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During the 8-day follow-up period (Day 0-7) after dose 4 and dose 5 vaccinationPopulation: The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed.
Any fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 fever was axillary temperature \> 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
ActHIB- Infanrix Group
n=209 Participants
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=408 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
n=217 Participants
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=384 Participants
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Grade3 loss of appetite, Dose4
|
3 Participants
|
7 Participants
|
5 Participants
|
7 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Related loss of apetite, Dose4
|
42 Participants
|
115 Participants
|
55 Participants
|
105 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Related fever, Dose 4
|
7 Participants
|
32 Participants
|
16 Participants
|
23 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Any irritability, Dose 4
|
114 Participants
|
230 Participants
|
128 Participants
|
218 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Grade3 irritability, Dose 4
|
7 Participants
|
13 Participants
|
11 Participants
|
12 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Related irritability, Dose4
|
90 Participants
|
202 Participants
|
106 Participants
|
188 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Any loss of appetite, Dose4
|
55 Participants
|
144 Participants
|
73 Participants
|
138 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Any drowsiness, Dose 4
|
79 Participants
|
171 Participants
|
97 Participants
|
161 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Grade3 drowsiness, Dose 4
|
1 Participants
|
7 Participants
|
6 Participants
|
8 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Related drowsiness, Dose 4
|
62 Participants
|
148 Participants
|
80 Participants
|
132 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Any fever, Dose4
|
14 Participants
|
46 Participants
|
23 Participants
|
37 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Grade3 fever, Dose 4
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Any drowsiness, Dose 5
|
—
|
132 Participants
|
67 Participants
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Grade3 drowsiness, Dose 5
|
—
|
7 Participants
|
6 Participants
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Related drowsiness, Dose 5
|
—
|
114 Participants
|
60 Participants
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Any fever, Dose 5
|
—
|
34 Participants
|
16 Participants
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Grade 3 fever, Dose 5
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Related fever, Dose 5
|
—
|
23 Participants
|
12 Participants
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Any irritability, Dose 5
|
—
|
195 Participants
|
103 Participants
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Grade 3 irritabiity, Dose 5
|
—
|
12 Participants
|
8 Participants
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Related irritability, Dose 5
|
—
|
171 Participants
|
99 Participants
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Any loss of appetite, Dose 5
|
—
|
117 Participants
|
62 Participants
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Grade 3 loss of appetite, Dose 5
|
—
|
2 Participants
|
5 Participants
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Related loss of appetite, Dose 5
|
—
|
86 Participants
|
53 Participants
|
—
|
SECONDARY outcome
Timeframe: From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)Population: The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.
Examples of rash included hives, idiopathic thrombocytopenic purpura, petechiae.
Outcome measures
| Measure |
ActHIB- Infanrix Group
n=233 Participants
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=432 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
n=229 Participants
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=409 Participants
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any Rash
|
40 Participants
|
93 Participants
|
54 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: During the 8-day follow-up period (Day 0-7) after vaccination in the booster phasePopulation: The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed.
Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was \> 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful.
Outcome measures
| Measure |
ActHIB- Infanrix Group
n=210 Participants
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=385 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
n=197 Participants
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=374 Participants
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine
Any pain
|
99 Participants
|
145 Participants
|
99 Participants
|
156 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine
Grade 3 pain
|
4 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine
Any redness
|
121 Participants
|
175 Participants
|
102 Participants
|
171 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine
Grade 3 redness
|
4 Participants
|
9 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine
Any swelling
|
80 Participants
|
114 Participants
|
73 Participants
|
113 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine
Grade 3 swelling
|
5 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)Population: The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.
NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Outcome measures
| Measure |
ActHIB- Infanrix Group
n=233 Participants
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=432 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
n=229 Participants
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=409 Participants
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits
Any NOCI(s)
|
13 Participants
|
19 Participants
|
11 Participants
|
18 Participants
|
|
Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits
Any ER visit(s)
|
29 Participants
|
73 Participants
|
49 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13)Population: The analysis was performed on Primary Total Vaccinated cohort which included all subjects who had received a study vaccine during the primary phase.
NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Outcome measures
| Measure |
ActHIB- Infanrix Group
n=1272 Participants
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=282 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits
Any NOCI(s)
|
128 Participants
|
29 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits
Any ER visit(s)
|
293 Participants
|
55 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During a 31-day follow-up period (Day 0-30)Population: The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.
Unsolicited AE covers any AE 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
ActHIB- Infanrix Group
n=233 Participants
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=432 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
n=229 Participants
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=409 Participants
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination
|
101 Participants
|
194 Participants
|
105 Participants
|
182 Participants
|
SECONDARY outcome
Timeframe: During the 31-day follow-up period (Day 0-30)Population: The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.
Unsolicited AE covers any AE 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
ActHIB- Infanrix Group
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=432 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
n=229 Participants
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any Unsolicited AEs in Nimenrix 1 Group and Menhibrix 2 Group After the Second Booster Phase Vaccination
|
—
|
167 Participants
|
79 Participants
|
—
|
SECONDARY outcome
Timeframe: From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13).Population: The analysis was performed on Primary Total Vaccinated cohort which included all subjects who had received a study vaccine during the primary phase.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
ActHIB- Infanrix Group
n=1272 Participants
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=282 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Any SAE(s)
|
58 Participants
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Related SAE(s)
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)Population: The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
ActHIB- Infanrix Group
n=233 Participants
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=432 Participants
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
n=229 Participants
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=409 Participants
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Any SAE(s)
|
2 Participants
|
15 Participants
|
3 Participants
|
9 Participants
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Related SAE(s)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Menhibrix 1 Group
Serious events: 58 serious events
Other events: 0 other events
Deaths: 0 deaths
ActHIB- Infanrix Group
Serious events: 14 serious events
Other events: 181 other events
Deaths: 0 deaths
Nimenrix 1 Group
Serious events: 15 serious events
Other events: 387 other events
Deaths: 0 deaths
Menhibrix 2 Group
Serious events: 3 serious events
Other events: 211 other events
Deaths: 0 deaths
Nimenrix 2 Group
Serious events: 9 serious events
Other events: 337 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Menhibrix 1 Group
n=1272 participants at risk
Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
|
ActHIB- Infanrix Group
n=233 participants at risk；n=282 participants at risk
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=432 participants at risk
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
n=229 participants at risk
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=409 participants at risk
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|---|
|
Infections and infestations
Bronchiolitis
|
0.71%
9/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Metabolism and nutrition disorders
Dehydration
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
1.2%
5/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.49%
2/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Gastroenteritis
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.23%
1/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.24%
1/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.23%
1/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.44%
1/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Nervous system disorders
Convulsion
|
0.24%
3/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.35%
1/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Croup infectious
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.23%
1/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Otitis media
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.46%
2/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.24%
1/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
General disorders
Pyrexia
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.23%
1/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.24%
1/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.31%
4/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Cellulitis
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.23%
1/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Pneumonia
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.69%
3/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.16%
2/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.35%
1/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.71%
2/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.16%
2/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Gastrointestinal disorders
Dysphagia
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.35%
1/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Otitis media acute
|
0.16%
2/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.16%
2/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Subcutaneous abscess
|
0.16%
2/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
General disorders
Sudden infant death syndrome
|
0.16%
2/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Viral infection
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.23%
1/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Respiratory, thoracic and mediastinal disorders
Apparent life threatening event
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.43%
1/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.23%
1/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.35%
1/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Bronchopneumonia
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.35%
1/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Cardiac disorders
Cyanosis
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Injury, poisoning and procedural complications
Fall
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Nervous system disorders
Febrile convulsion
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.87%
2/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Gastrointestinal disorders
Gastric volvulus
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Gastrointestinal disorders
Haematemesis
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Nervous system disorders
Hypotonia
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Influenza
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
General disorders
Irritability
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.35%
1/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Pertussis
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.35%
1/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Pyelonephritis
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Pyelonephritis acute
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Septic shock
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.35%
1/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Staphylococcal infection
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.23%
1/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.24%
1/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Cardiac disorders
Tachycardia
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Urinary tract infection
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Urosepsis
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Gastrointestinal disorders
Vomiting
|
0.08%
1/1272 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/282 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.23%
1/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.24%
1/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Abscess
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.23%
1/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Metabolism and nutrition disorders
Acidosis
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.44%
1/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Surgical and medical procedures
Adenoidectomy
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.23%
1/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Encephalitis viral
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.44%
1/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Musculoskeletal and connective tissue disorders
Floppy infant
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.24%
1/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Gastroenteritis viral
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.24%
1/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Herpes oesophagitis
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.43%
1/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.24%
1/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory distress
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.23%
1/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Nervous system disorders
Somnolence
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.23%
1/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.24%
1/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.44%
1/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Upper respiratory infection
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.44%
1/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Wound infection
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.24%
1/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Respiratory syncitial virus bronchiolitis
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/233 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.23%
1/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.00%
0/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
0.24%
1/409 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
Other adverse events
| Measure |
Menhibrix 1 Group
n=1272 participants at risk
Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
|
ActHIB- Infanrix Group
n=233 participants at risk；n=282 participants at risk
Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
|
Nimenrix 1 Group
n=432 participants at risk
Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Menhibrix 2 Group
n=229 participants at risk
Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
Nimenrix 2 Group
n=409 participants at risk
Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
|
|---|---|---|---|---|---|
|
General disorders
Pain
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
47.1%
99/210 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
37.7%
145/385 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
50.3%
99/197 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
41.7%
156/374 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
General disorders
Redness
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
57.6%
121/210 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
45.5%
175/385 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
51.8%
102/197 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
45.7%
171/374 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
General disorders
Swelling
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
38.1%
80/210 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
29.6%
114/385 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
37.1%
73/197 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
30.2%
113/374 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
General disorders
Drowsiness
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
34.4%
132/384 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
34.0%
67/197 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
General disorders
Fever
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
8.9%
34/384 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
8.1%
16/197 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
General disorders
Irritability
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
50.8%
195/384 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
52.3%
103/197 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
General disorders
Loss of appetite
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
30.5%
117/384 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
31.5%
62/197 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Otitis media
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
6.2%
27/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
5.7%
13/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Infections and infestations
Upper respiratory tract infection
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
6.2%
27/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
5.7%
13/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
|
Gastrointestinal disorders
Diarrhoea
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
3.0%
13/432 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
5.7%
13/229 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
—
0/0 • Serious adverse events were assessed from Month 0 up to Month 19-22. Systematically and non-systematically assessed frequent adverse events were assessed during the 8 day (Day 0-7) and 31 day (Day 0-30) period respectively after booster vaccination.
Participants at risk for systematically assessed adverse events (AEs) = Booster Total Vaccinated cohort with symptom sheet completed and for non-systematically assessed other (non-serious) AEs = Booster Total Vaccinated cohort. For serious AEs, participants at risk = Primary Total Vaccinated cohort and Booster Total Vaccinated cohort respectively. Other Adverse Events were not collected for Menhibrix 1 Group.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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