Trial Outcomes & Findings for Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines (NCT NCT01144663)
NCT ID: NCT01144663
Last Updated: 2020-12-31
Results Overview
The cut-off value for the rSBA-MenA, rSBA-MenW-135 and rSBA-Y titers was greater than or equal to (≥) 1:8. Indication of the immunogenicity of the 2-dose and 3-dose schedules: the lower limit of the two-sided exact 95% CI for the percentage of subjects with post-primary vaccination rSBA antibody titre ≥ 1:8 is greater than or equal to the pre-defined clinical limit of 80%.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2095 participants
Primary outcome timeframe
One month after the final primary vaccination at Month 3
Results posted on
2020-12-31
Participant Flow
Participant milestones
| Measure |
Nimenrix 3 Group
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Menjugate Group
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Primary Vaccination Phase
STARTED
|
528
|
524
|
516
|
527
|
|
Primary Vaccination Phase
COMPLETED
|
508
|
517
|
508
|
509
|
|
Primary Vaccination Phase
NOT COMPLETED
|
20
|
7
|
8
|
18
|
|
Booster Vaccination Phase
STARTED
|
497
|
511
|
503
|
506
|
|
Booster Vaccination Phase
COMPLETED
|
494
|
509
|
498
|
505
|
|
Booster Vaccination Phase
NOT COMPLETED
|
3
|
2
|
5
|
1
|
|
Extended Safety Follow-Up (ESFU)
STARTED
|
497
|
511
|
503
|
506
|
|
Extended Safety Follow-Up (ESFU)
COMPLETED
|
492
|
502
|
496
|
505
|
|
Extended Safety Follow-Up (ESFU)
NOT COMPLETED
|
5
|
9
|
7
|
1
|
Reasons for withdrawal
| Measure |
Nimenrix 3 Group
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Menjugate Group
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Primary Vaccination Phase
Serious adverse event, fatal
|
2
|
0
|
1
|
0
|
|
Primary Vaccination Phase
Adverse Event
|
1
|
0
|
0
|
1
|
|
Primary Vaccination Phase
Protocol Violation
|
2
|
0
|
1
|
0
|
|
Primary Vaccination Phase
Withdrawal by Subject
|
9
|
5
|
3
|
10
|
|
Primary Vaccination Phase
Migrated/moved from study area
|
4
|
1
|
2
|
3
|
|
Primary Vaccination Phase
Lost to Follow-up
|
2
|
0
|
1
|
2
|
|
Primary Vaccination Phase
Other
|
0
|
1
|
0
|
2
|
|
Booster Vaccination Phase
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
|
Booster Vaccination Phase
Migrated/moved from study area
|
1
|
1
|
1
|
0
|
|
Booster Vaccination Phase
Lost to Follow-up
|
2
|
1
|
3
|
0
|
|
Extended Safety Follow-Up (ESFU)
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
|
Extended Safety Follow-Up (ESFU)
Migrated/moved from study area
|
1
|
3
|
1
|
0
|
|
Extended Safety Follow-Up (ESFU)
Lost to Follow-up
|
4
|
6
|
5
|
0
|
Baseline Characteristics
Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines
Baseline characteristics by cohort
| Measure |
Nimenrix 3 Group
n=528 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=524 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Menjugate Group
n=516 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=527 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Total
n=2095 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
8.7 Weeks
STANDARD_DEVIATION 1.54 • n=39 Participants
|
8.6 Weeks
STANDARD_DEVIATION 1.52 • n=41 Participants
|
8.7 Weeks
STANDARD_DEVIATION 1.53 • n=35 Participants
|
8.6 Weeks
STANDARD_DEVIATION 1.49 • n=31 Participants
|
8.65 Weeks
STANDARD_DEVIATION 1.52 • n=146 Participants
|
|
Sex: Female, Male
Female
|
255 Participants
n=39 Participants
|
273 Participants
n=41 Participants
|
264 Participants
n=35 Participants
|
251 Participants
n=31 Participants
|
1043 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
273 Participants
n=39 Participants
|
251 Participants
n=41 Participants
|
252 Participants
n=35 Participants
|
276 Participants
n=31 Participants
|
1052 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · African heritage/African American
|
5 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
16 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · American Indian or Alaskan Native
|
1 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
11 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian-Central/South Asian heritage
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian-East Asian heritage
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian-South East Asian heritage
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Native Hawaiian or other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White-Arabic/North African heritage
|
12 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
21 Participants
n=31 Participants
|
51 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White-Caucasian/European heritage
|
500 Participants
n=39 Participants
|
497 Participants
n=41 Participants
|
486 Participants
n=35 Participants
|
495 Participants
n=31 Participants
|
1978 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Not specified
|
8 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
32 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: One month after the final primary vaccination at Month 3Population: The analysis was performed on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all subjects who complied with the protocol, who were administered a vaccine containing rSBA-MenA, rSBA-MenW-135 and rSBA-Y components (i.e. only Group Nimenrix 3 and Nimenrix 2) and with available data for the considered assay and time point.
The cut-off value for the rSBA-MenA, rSBA-MenW-135 and rSBA-Y titers was greater than or equal to (≥) 1:8. Indication of the immunogenicity of the 2-dose and 3-dose schedules: the lower limit of the two-sided exact 95% CI for the percentage of subjects with post-primary vaccination rSBA antibody titre ≥ 1:8 is greater than or equal to the pre-defined clinical limit of 80%.
Outcome measures
| Measure |
Menjugate Group
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=462 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=456 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Percentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value.
rSBA-MenA
|
—
|
—
|
99.4 Percentage of Participants
Interval 98.1 to 99.9
|
97.4 Percentage of Participants
Interval 95.4 to 98.6
|
|
Percentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value.
rSBA-MenW-135
|
—
|
—
|
99.1 Percentage of Participants
Interval 97.8 to 99.8
|
99.1 Percentage of Participants
Interval 97.8 to 99.8
|
|
Percentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value.
rSBA-MenY
|
—
|
—
|
93.1 Percentage of Participants
Interval 90.3 to 95.2
|
98.2 Percentage of Participants
Interval 96.6 to 99.2
|
PRIMARY outcome
Timeframe: One month after the final primary vaccination at Month 3Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2)and with the blood sample schedule for Visit 4 (Month 3).
The cut-off value for rSBA-MenC titers was ≥ 1:8.
Outcome measures
| Measure |
Menjugate Group
n=455 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=457 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=461 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=456 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ the Cut-off Value
|
453 Participants
|
457 Participants
|
459 Participants
|
450 Participants
|
SECONDARY outcome
Timeframe: Pre-primary vaccination at Month 0Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for a randomized subset of 50% subjects for each of the 4 serogroups in the investigational groups, and in a randomized subset of 50% and 25% subjects for MenC, MenA, MenW, MenY in control groups.
The cut-off values for rSBA-Men antibody titers were greater than or equal to (≥) 1:8 and ≥ 1:128 at pre-vaccination
Outcome measures
| Measure |
Menjugate Group
n=207 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=220 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=223 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=220 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values
rSBA-MenA ≥ 1:8
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values
rSBA-MenW-135 ≥ 1:8
|
5 Participants
|
3 Participants
|
8 Participants
|
12 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values
rSBA-MenA ≥ 1:128
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values
rSBA-MenC ≥ 1:8
|
15 Participants
|
14 Participants
|
12 Participants
|
10 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values
rSBA-MenC ≥ 1:128
|
6 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values
rSBA-MenW-135 ≥ 1:128
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values
rSBA-MenY ≥ 1:8
|
8 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values
rSBA-MenY ≥ 1:128
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Pre-primary vaccination at Month 0Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for a randomized subset of 50% subjects for each of the 4 serogroups in the investigational groups, and in a randomized subset of 50% and 25% subjects for MenC, MenA, MenW, MenY in control groups.
Antibody titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Menjugate Group
n=207 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=220 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=223 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=220 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenA
|
4.1 Titers
Interval 4.0 to 4.3
|
4.1 Titers
Interval 3.9 to 4.3
|
4.1 Titers
Interval 4.0 to 4.2
|
4.1 Titers
Interval 4.0 to 4.2
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenC
|
4.9 Titers
Interval 4.4 to 5.5
|
4.7 Titers
Interval 4.3 to 5.2
|
4.4 Titers
Interval 4.1 to 4.8
|
4.3 Titers
Interval 4.1 to 4.5
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenW-135
|
4.3 Titers
Interval 3.9 to 4.8
|
4.3 Titers
Interval 3.9 to 4.7
|
4.3 Titers
Interval 4.1 to 4.5
|
4.4 Titers
Interval 4.1 to 4.6
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenY
|
4.7 Titers
Interval 4.2 to 5.2
|
4.2 Titers
Interval 3.9 to 4.6
|
4.2 Titers
Interval 4.0 to 4.4
|
4.2 Titers
Interval 4.0 to 4.5
|
SECONDARY outcome
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11).
The cut-off values for the rSBA-Men antibody titers were greater than or equal to (≥) 1:8 and ≥ 1:128.
Outcome measures
| Measure |
Menjugate Group
n=446 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=461 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=441 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=463 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values
rSBA-MenA ≥ 1:128, Month 10
|
11 Participants
|
3 Participants
|
107 Participants
|
99 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values
rSBA-MenW-135 ≥ 1:8, Month 10
|
18 Participants
|
27 Participants
|
372 Participants
|
417 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values
rSBA-MenW-135 ≥ 1:128, Month 10
|
16 Participants
|
22 Participants
|
221 Participants
|
254 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values
rSBA-MenY ≥ 1:128, Month 10
|
41 Participants
|
37 Participants
|
126 Participants
|
168 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values
rSBA-MenY ≥ 1:8, Month 11
|
45 Participants
|
40 Participants
|
436 Participants
|
459 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values
rSBA-MenA ≥ 1:8, Month 10
|
26 Participants
|
23 Participants
|
300 Participants
|
279 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values
rSBA-MenA ≥ 1:8, Month 11
|
21 Participants
|
19 Participants
|
437 Participants
|
460 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values
rSBA-MenA ≥ 1:128, Month 11
|
8 Participants
|
12 Participants
|
433 Participants
|
456 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values
rSBA-MenC ≥ 1:8, Month 10
|
229 Participants
|
356 Participants
|
324 Participants
|
348 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values
rSBA-MenC ≥ 1:128, Month 10
|
79 Participants
|
195 Participants
|
108 Participants
|
183 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values
rSBA-MenC ≥ 1:8, Month 11
|
439 Participants
|
459 Participants
|
437 Participants
|
462 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values
rSBA-MenC ≥ 1:128, Month 11
|
426 Participants
|
457 Participants
|
432 Participants
|
454 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values
rSBA-MenW-135 ≥ 1:8, Month 11
|
34 Participants
|
37 Participants
|
433 Participants
|
461 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values
rSBA-MenW-135 ≥ 1:128, Month 11
|
31 Participants
|
31 Participants
|
430 Participants
|
457 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values
rSBA-MenY ≥ 1:8, Month 10
|
54 Participants
|
47 Participants
|
364 Participants
|
383 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values
rSBA-MenY ≥ 1:128, Month 11
|
37 Participants
|
34 Participants
|
419 Participants
|
445 Participants
|
SECONDARY outcome
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11).
Antibody titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Menjugate Group
n=446 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=461 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=441 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=463 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenY, Month 10
|
6.5 Titers
Interval 5.7 to 7.4
|
6.0 Titers
Interval 5.4 to 6.8
|
35.4 Titers
Interval 30.6 to 41.0
|
47.0 Titers
Interval 40.3 to 54.7
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenA, Month 10
|
4.7 Titers
Interval 4.3 to 5.0
|
4.4 Titers
Interval 4.2 to 4.6
|
22.9 Titers
Interval 19.8 to 26.5
|
19.5 Titers
Interval 16.8 to 22.6
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenA, Month 11
|
4.6 Titers
Interval 4.3 to 4.9
|
4.7 Titers
Interval 4.3 to 5.0
|
1417.6 Titers
Interval 1281.4 to 1568.3
|
1561.0 Titers
Interval 1412.3 to 1725.3
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenC, Month 10
|
16.0 Titers
Interval 13.8 to 18.5
|
49.3 Titers
Interval 42.1 to 57.7
|
25.7 Titers
Interval 22.3 to 29.6
|
43.7 Titers
Interval 37.4 to 51.1
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenC, Month 11
|
1051.4 Titers
Interval 919.6 to 1202.1
|
1960.2 Titers
Interval 1776.4 to 2163.1
|
1154.6 Titers
Interval 1034.1 to 1289.0
|
1177.0 Titers
Interval 1059.1 to 1308.0
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenW-135, Month 10
|
4.7 Titers
Interval 4.4 to 5.1
|
5.0 Titers
Interval 4.6 to 5.5
|
68.7 Titers
Interval 58.3 to 81.0
|
97.7 Titers
Interval 83.3 to 114.5
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenW-135, Month 11
|
5.5 Titers
Interval 5.0 to 6.1
|
5.6 Titers
Interval 5.0 to 6.2
|
1955.9 Titers
Interval 1729.6 to 2211.9
|
2777.2 Titers
Interval 2485.1 to 3103.6
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenY, Month 11
|
6.1 Titers
Interval 5.4 to 6.8
|
5.8 Titers
Interval 5.2 to 6.6
|
630.6 Titers
Interval 564.1 to 705.1
|
881.3 Titers
Interval 787.5 to 986.4
|
SECONDARY outcome
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who used hSBA complement and who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3).
The cut-off values for hSBA antibody titers were greater than or equal to (≥) 1:4 and ≥ 1:8.
Outcome measures
| Measure |
Menjugate Group
n=205 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=226 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=214 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=218 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values
hSBA-MenC ≥ 1:4, Month 3
|
202 Participants
|
226 Participants
|
213 Participants
|
215 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values
hSBA-MenC ≥ 1:8, Month 3
|
202 Participants
|
226 Participants
|
213 Participants
|
215 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values
hSBA-MenW-135 ≥ 1:4, Month 0
|
54 Participants
|
37 Participants
|
50 Participants
|
46 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values
hSBA-MenA ≥ 1:4, Month 0
|
41 Participants
|
34 Participants
|
34 Participants
|
31 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values
hSBA-MenA ≥ 1:8, Month 0
|
27 Participants
|
27 Participants
|
28 Participants
|
19 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values
hSBA-MenA ≥ 1:4, Month 3
|
21 Participants
|
18 Participants
|
197 Participants
|
195 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values
hSBA-MenA ≥ 1:8, Month 3
|
15 Participants
|
14 Participants
|
196 Participants
|
195 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values
hSBA-MenC ≥ 1:4, Month 0
|
50 Participants
|
44 Participants
|
43 Participants
|
35 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values
hSBA-MenC ≥ 1:8, Month 0
|
49 Participants
|
42 Participants
|
43 Participants
|
35 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values
hSBA-MenW-135 ≥ 1:8, Month 0
|
52 Participants
|
36 Participants
|
49 Participants
|
44 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values
hSBA-MenW-135 ≥ 1:4, Month 3
|
6 Participants
|
3 Participants
|
197 Participants
|
217 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values
hSBA-MenW-135 ≥ 1:8, Month 3
|
4 Participants
|
3 Participants
|
197 Participants
|
217 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values
hSBA-MenY ≥ 1:4, Month 0
|
71 Participants
|
78 Participants
|
73 Participants
|
73 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values
hSBA-MenY ≥ 1:8, Month 0
|
71 Participants
|
77 Participants
|
73 Participants
|
72 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values
hSBA-MenY ≥ 1:4, Month 3
|
11 Participants
|
5 Participants
|
187 Participants
|
209 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values
hSBA-MenY ≥ 1:8, Month 3
|
11 Participants
|
4 Participants
|
185 Participants
|
209 Participants
|
SECONDARY outcome
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who used hSBA complement and who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3).
Antibody titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Menjugate Group
n=205 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=226 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=214 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=218 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenC, Month 3
|
3188.1 Titers
Interval 2645.8 to 3841.5
|
2626.5 Titers
Interval 2218.9 to 3109.0
|
765.6 Titers
Interval 647.4 to 905.3
|
1308.3 Titers
Interval 1051.7 to 1627.4
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenY, Month 0
|
7.1 Titers
Interval 5.5 to 9.2
|
8.1 Titers
Interval 6.3 to 10.4
|
8 Titers
Interval 6.1 to 10.5
|
8 Titers
Interval 6.1 to 10.5
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenA, Month 0
|
3 Titers
Interval 2.7 to 3.4
|
2.9 Titers
Interval 2.6 to 3.3
|
2.8 Titers
Interval 2.5 to 3.2
|
2.7 Titers
Interval 2.4 to 3.0
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenA, Month 3
|
2.5 Titers
Interval 2.2 to 2.7
|
2.3 Titers
Interval 2.2 to 2.5
|
240.9 Titers
Interval 207.8 to 279.3
|
157.2 Titers
Interval 131.4 to 188.1
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenC, Month 0
|
4.9 Titers
Interval 3.9 to 6.2
|
3.9 Titers
Interval 3.2 to 4.7
|
3.9 Titers
Interval 3.2 to 4.7
|
3.6 Titers
Interval 3.0 to 4.4
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenW-135, Month 0
|
5 Titers
Interval 4.0 to 6.3
|
3.7 Titers
Interval 3.1 to 4.6
|
5 Titers
Interval 3.9 to 6.3
|
4.7 Titers
Interval 3.8 to 6.0
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenW-135, Month 3
|
2.1 Titers
Interval 2.0 to 2.3
|
2.1 Titers
Interval 2.0 to 2.3
|
190.9 Titers
Interval 160.0 to 227.8
|
753.5 Titers
Interval 643.8 to 881.8
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenY, Month 3
|
2.4 Titers
Interval 2.1 to 2.7
|
2.1 Titers
Interval 2.0 to 2.2
|
66.5 Titers
Interval 53.7 to 82.2
|
328.1 Titers
Interval 275.8 to 390.2
|
SECONDARY outcome
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who used hSBA complement and who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11).
The cut-off values for hSBA antibody titers were greater than or equal to (≥) 1:4 and ≥ 1:8.
Outcome measures
| Measure |
Menjugate Group
n=219 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=219 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=213 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=221 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values
hSBA-MenA ≥ 1:4, Month 11
|
50 Participants
|
55 Participants
|
210 Participants
|
213 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values
hSBA-MenA ≥ 1:4, Month 10
|
28 Participants
|
26 Participants
|
142 Participants
|
119 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values
hSBA-MenA ≥ 1:8, Month 10
|
26 Participants
|
26 Participants
|
141 Participants
|
119 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values
hSBA-MenA ≥ 1:8, Month 11
|
50 Participants
|
55 Participants
|
210 Participants
|
213 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values
hSBA-MenC ≥ 1:4, Month 10
|
160 Participants
|
196 Participants
|
184 Participants
|
198 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values
hSBA-MenC ≥ 1:8, Month 10
|
160 Participants
|
196 Participants
|
184 Participants
|
198 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values
hSBA-MenC ≥ 1:4, Month 11
|
216 Participants
|
219 Participants
|
212 Participants
|
220 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values
hSBA-MenC ≥ 1:8, Month 11
|
216 Participants
|
219 Participants
|
212 Participants
|
220 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values
hSBA-MenW-135 ≥ 1:4, Month 10
|
1 Participants
|
6 Participants
|
196 Participants
|
201 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values
hSBA-MenW-135 ≥ 1:8, Month 10
|
1 Participants
|
6 Participants
|
196 Participants
|
201 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values
hSBA-MenW-135 ≥ 1:4, Month 11
|
3 Participants
|
6 Participants
|
207 Participants
|
218 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values
hSBA-MenW-135 ≥ 1:8, Month 11
|
3 Participants
|
6 Participants
|
207 Participants
|
218 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values
hSBA-MenY ≥ 1:4, Month 10
|
6 Participants
|
10 Participants
|
185 Participants
|
204 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values
hSBA-MenY ≥ 1:8, Month 10
|
6 Participants
|
10 Participants
|
185 Participants
|
204 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values
hSBA-MenY ≥ 1:4, Month 11
|
7 Participants
|
12 Participants
|
206 Participants
|
217 Participants
|
|
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values
hSBA-MenY ≥ 1:8, Month 11
|
7 Participants
|
12 Participants
|
206 Participants
|
217 Participants
|
SECONDARY outcome
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who used hSBA complement and who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11).
Antibody titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Menjugate Group
n=219 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=219 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=213 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=221 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenA, Month 10
|
2.7 Titers
Interval 2.4 to 3.0
|
2.7 Titers
Interval 2.4 to 3.1
|
32.0 Titers
Interval 24.2 to 42.2
|
14.5 Titers
Interval 11.2 to 18.7
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenA, Month 11
|
3.9 Titers
Interval 3.3 to 4.6
|
4.2 Titers
Interval 3.5 to 5.0
|
1192.7 Titers
Interval 978.4 to 1453.9
|
1007.2 Titers
Interval 835.7 to 1213.8
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenC, Month 10
|
76.8 Titers
Interval 58.5 to 100.8
|
213.7 Titers
Interval 174.6 to 261.7
|
116.1 Titers
Interval 94.2 to 143.0
|
181.4 Titers
Interval 147.3 to 223.4
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenC, Month 11
|
5438.2 Titers
Interval 4412.4 to 6702.3
|
5542.3 Titers
Interval 4765.2 to 6446.2
|
4411.2 Titers
Interval 3654.5 to 5324.6
|
4992.3 Titers
Interval 4085.7 to 6100.0
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenW-135, Month 10
|
2.0 Titers
Interval 2.0 to 2.1
|
2.3 Titers
Interval 2.0 to 2.6
|
248.1 Titers
Interval 210.4 to 292.6
|
332.4 Titers
Interval 287.3 to 384.5
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenW-135, Month 11
|
2.1 Titers
Interval 2.0 to 2.2
|
2.3 Titers
Interval 2.1 to 2.7
|
3944.9 Titers
Interval 3419.1 to 4551.7
|
5122.7 Titers
Interval 4504.2 to 5826.1
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenY, Month 10
|
2.2 Titers
Interval 2.0 to 2.4
|
2.4 Titers
Interval 2.1 to 2.7
|
99.8 Titers
Interval 80.7 to 123.5
|
140.2 Titers
Interval 116.2 to 169.2
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
hSBA-MenY, Month 11
|
2.3 Titers
Interval 2.1 to 2.6
|
2.4 Titers
Interval 2.2 to 2.7
|
2491.5 Titers
Interval 2125.8 to 2920.1
|
2954.0 Titers
Interval 2497.9 to 3493.3
|
SECONDARY outcome
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.
The cut-off values for anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F concentrations were greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL) and ≥ 0.35 µg/mL
Outcome measures
| Measure |
Menjugate Group
n=95 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=103 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=98 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=104 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-1 ≥ 0.15 µg/mL, Month 0
|
17 Participants
|
18 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-1 ≥ 0.35 µg/mL, Month 0
|
8 Participants
|
8 Participants
|
3 Participants
|
9 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-1 ≥ 0.15 µg/mL, Month 3
|
93 Participants
|
103 Participants
|
96 Participants
|
102 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-1 ≥ 0.35 µg/mL, Month 3
|
89 Participants
|
91 Participants
|
93 Participants
|
95 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-4 ≥ 0.15 µg/mL, Month 0
|
13 Participants
|
12 Participants
|
11 Participants
|
11 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-4 ≥ 0.35 µg/mL, Month 0
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-4 ≥ 0.15 µg/mL, Month 3
|
95 Participants
|
103 Participants
|
96 Participants
|
102 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-4 ≥ 0.35 µg/mL, Month 3
|
93 Participants
|
99 Participants
|
94 Participants
|
99 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-5 ≥ 0.15 µg/mL, Month 0
|
39 Participants
|
33 Participants
|
42 Participants
|
32 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-5 ≥ 0.35 µg/mL, Month 0
|
9 Participants
|
14 Participants
|
10 Participants
|
5 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-5 ≥ 0.15 µg/mL, Month 3
|
93 Participants
|
101 Participants
|
95 Participants
|
102 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-5 ≥ 0.35 µg/mL, Month 3
|
80 Participants
|
92 Participants
|
84 Participants
|
86 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-6B ≥ 0.15 µg/mL, Month 0
|
41 Participants
|
50 Participants
|
55 Participants
|
42 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-6B ≥ 0.35 µg/mL, Month 0
|
20 Participants
|
26 Participants
|
27 Participants
|
19 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-6B ≥ 0.15 µg/mL, Month 3
|
88 Participants
|
90 Participants
|
88 Participants
|
95 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-6B ≥ 0.35 µg/mL, Month 3
|
75 Participants
|
81 Participants
|
71 Participants
|
82 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-7F ≥ 0.15 µg/mL, Month 0
|
44 Participants
|
49 Participants
|
38 Participants
|
43 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-7F ≥ 0.35 µg/mL, Month 0
|
20 Participants
|
16 Participants
|
13 Participants
|
18 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-7F ≥ 0.15 µg/mL, Month 3
|
93 Participants
|
103 Participants
|
96 Participants
|
102 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-7F ≥ 0.35 µg/mL, Month 3
|
93 Participants
|
103 Participants
|
94 Participants
|
99 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-9V ≥ 0.15 µg/mL, Month 0
|
35 Participants
|
43 Participants
|
38 Participants
|
44 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-9V ≥ 0.35 µg/mL, Month 0
|
12 Participants
|
16 Participants
|
9 Participants
|
18 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-9V ≥ 0.15 µg/mL, Month 3
|
90 Participants
|
103 Participants
|
94 Participants
|
102 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-9V ≥ 0.35 µg/mL, Month 3
|
88 Participants
|
99 Participants
|
92 Participants
|
99 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-14 ≥ 0.15 µg/mL, Month 0
|
74 Participants
|
80 Participants
|
72 Participants
|
69 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-14 ≥ 0.35 µg/mL, Month 0
|
57 Participants
|
67 Participants
|
53 Participants
|
57 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-14 ≥ 0.15 µg/mL, Month 3
|
95 Participants
|
103 Participants
|
96 Participants
|
103 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-14 ≥ 0.35 µg/mL, Month 3
|
95 Participants
|
103 Participants
|
96 Participants
|
103 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-18C ≥ 0.15 µg/mL, Month 0
|
45 Participants
|
43 Participants
|
30 Participants
|
44 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-18C ≥ 0.35 µg/mL, Month 0
|
20 Participants
|
10 Participants
|
14 Participants
|
18 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-18C ≥ 0.15 µg/mL, Month 3
|
93 Participants
|
103 Participants
|
96 Participants
|
101 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-18C ≥ 0.35 µg/mL, Month 3
|
89 Participants
|
101 Participants
|
90 Participants
|
100 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-19F ≥ 0.15 µg/mL, Month 0
|
51 Participants
|
53 Participants
|
41 Participants
|
61 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-19F ≥ 0.35 µg/mL, Month 0
|
27 Participants
|
23 Participants
|
21 Participants
|
30 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-19F ≥ 0.15 µg/mL, Month 3
|
94 Participants
|
102 Participants
|
94 Participants
|
100 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-19F ≥ 0.35 µg/mL, Month 3
|
90 Participants
|
99 Participants
|
92 Participants
|
94 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-23F ≥ 0.15 µg/mL, Month 0
|
29 Participants
|
40 Participants
|
37 Participants
|
38 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-23F ≥ 0.35 µg/mL, Month 0
|
13 Participants
|
18 Participants
|
16 Participants
|
13 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-23F ≥ 0.15 µg/mL, Month 3
|
91 Participants
|
98 Participants
|
90 Participants
|
99 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Anti-23F ≥ 0.35 µg/mL, Month 3
|
77 Participants
|
86 Participants
|
83 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.
Anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in µg/mL.
Outcome measures
| Measure |
Menjugate Group
n=95 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=103 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=98 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=104 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-4, Month 0
|
0.09 µg/mL
Interval 0.08 to 0.1
|
0.09 µg/mL
Interval 0.08 to 0.09
|
0.09 µg/mL
Interval 0.08 to 0.09
|
0.09 µg/mL
Interval 0.08 to 0.09
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-4, Month 3
|
1.77 µg/mL
Interval 1.5 to 2.1
|
1.60 µg/mL
Interval 1.37 to 1.85
|
1.84 µg/mL
Interval 1.58 to 2.15
|
1.56 µg/mL
Interval 1.31 to 1.86
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-5, Month 0
|
0.13 µg/mL
Interval 0.11 to 0.15
|
0.12 µg/mL
Interval 0.11 to 0.15
|
0.13 µg/mL
Interval 0.11 to 0.15
|
0.12 µg/mL
Interval 0.1 to 0.13
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-6B, Month 3
|
1.08 µg/mL
Interval 0.84 to 1.38
|
0.86 µg/mL
Interval 0.67 to 1.12
|
0.79 µg/mL
Interval 0.62 to 1.0
|
0.90 µg/mL
Interval 0.71 to 1.14
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-9V, Month 0
|
0.13 µg/mL
Interval 0.11 to 0.15
|
0.14 µg/mL
Interval 0.12 to 0.17
|
0.13 µg/mL
Interval 0.11 to 0.15
|
0.15 µg/mL
Interval 0.13 to 0.18
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-9V, Month 3
|
1.22 µg/mL
Interval 1.02 to 1.46
|
1.21 µg/mL
Interval 1.07 to 1.38
|
1.31 µg/mL
Interval 1.1 to 1.56
|
1.12 µg/mL
Interval 0.97 to 1.29
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-14, Month 0
|
0.59 µg/mL
Interval 0.44 to 0.79
|
0.74 µg/mL
Interval 0.56 to 0.99
|
0.50 µg/mL
Interval 0.37 to 0.67
|
0.61 µg/mL
Interval 0.44 to 0.85
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-19F, Month 0
|
0.20 µg/mL
Interval 0.16 to 0.25
|
0.19 µg/mL
Interval 0.15 to 0.23
|
0.15 µg/mL
Interval 0.13 to 0.19
|
0.23 µg/mL
Interval 0.19 to 0.28
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-23F, Month 3
|
1.08 µg/mL
Interval 0.86 to 1.36
|
0.94 µg/mL
Interval 0.77 to 1.16
|
0.96 µg/mL
Interval 0.78 to 1.18
|
0.85 µg/mL
Interval 0.69 to 1.06
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-1, Month 0
|
0.10 µg/mL
Interval 0.09 to 0.12
|
0.10 µg/mL
Interval 0.09 to 0.11
|
0.09 µg/mL
Interval 0.08 to 0.1
|
0.10 µg/mL
Interval 0.09 to 0.12
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-1, Month 3
|
1.26 µg/mL
Interval 1.06 to 1.5
|
1.02 µg/mL
Interval 0.88 to 1.18
|
1.36 µg/mL
Interval 1.15 to 1.62
|
1.13 µg/mL
Interval 0.96 to 1.34
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-5, Month 3
|
0.77 µg/mL
Interval 0.66 to 0.89
|
0.74 µg/mL
Interval 0.65 to 0.85
|
0.82 µg/mL
Interval 0.71 to 0.95
|
0.70 µg/mL
Interval 0.61 to 0.81
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-6B, Month 0
|
0.15 µg/mL
Interval 0.13 to 0.19
|
0.18 µg/mL
Interval 0.15 to 0.22
|
0.18 µg/mL
Interval 0.15 to 0.21
|
0.15 µg/mL
Interval 0.13 to 0.19
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-7F, Month 0
|
0.16 µg/mL
Interval 0.13 to 0.2
|
0.15 µg/mL
Interval 0.13 to 0.18
|
0.13 µg/mL
Interval 0.11 to 0.16
|
0.17 µg/mL
Interval 0.13 to 0.21
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-7F, Month 3
|
2.13 µg/mL
Interval 1.82 to 2.49
|
1.87 µg/mL
Interval 1.62 to 2.15
|
1.91 µg/mL
Interval 1.63 to 2.23
|
1.84 µg/mL
Interval 1.56 to 2.18
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-14, Month 3
|
8.51 µg/mL
Interval 7.09 to 10.22
|
6.04 µg/mL
Interval 5.04 to 7.24
|
7.55 µg/mL
Interval 6.4 to 8.9
|
7.40 µg/mL
Interval 6.35 to 8.62
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-18C, Month 0
|
0.17 µg/mL
Interval 0.14 to 0.21
|
0.14 µg/mL
Interval 0.12 to 0.16
|
0.13 µg/mL
Interval 0.11 to 0.16
|
0.16 µg/mL
Interval 0.13 to 0.2
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-18C, Month 3
|
2.39 µg/mL
Interval 1.96 to 2.93
|
2.80 µg/mL
Interval 2.4 to 3.27
|
2.14 µg/mL
Interval 1.74 to 2.64
|
1.77 µg/mL
Interval 1.47 to 2.13
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-19F, Month 3
|
2.89 µg/mL
Interval 2.26 to 3.69
|
2.85 µg/mL
Interval 2.29 to 3.54
|
3.01 µg/mL
Interval 2.37 to 3.82
|
2.60 µg/mL
Interval 2.01 to 3.35
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-23F, Month 0
|
0.13 µg/mL
Interval 0.11 to 0.15
|
0.15 µg/mL
Interval 0.12 to 0.17
|
0.14 µg/mL
Interval 0.11 to 0.16
|
0.14 µg/mL
Interval 0.11 to 0.17
|
SECONDARY outcome
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.
The cut-off values for anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F concentrations were ≥ 0.15 µg/mL and ≥ 0.35 µg/mL
Outcome measures
| Measure |
Menjugate Group
n=106 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=110 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=104 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=107 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-4 ≥ 0.15 µg/mL, Month 10
|
91 Participants
|
94 Participants
|
83 Participants
|
87 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-4 ≥ 0.35 µg/mL, Month 10
|
48 Participants
|
30 Participants
|
38 Participants
|
35 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-5 ≥ 0.15 µg/mL, Month 10
|
94 Participants
|
93 Participants
|
90 Participants
|
91 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-5 ≥ 0.35 µg/mL, Month 10
|
48 Participants
|
43 Participants
|
44 Participants
|
43 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-7F ≥ 0.35 µg/mL, Month 10
|
75 Participants
|
78 Participants
|
76 Participants
|
78 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-9V ≥ 0.35 µg/mL, Month 11
|
99 Participants
|
102 Participants
|
102 Participants
|
105 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-14 ≥ 0.35 µg/mL, Month 10
|
99 Participants
|
103 Participants
|
100 Participants
|
103 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-18C ≥ 0.35 µg/mL, Month 10
|
54 Participants
|
58 Participants
|
45 Participants
|
50 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-18C ≥ 0.15 µg/mL, Month 11
|
100 Participants
|
104 Participants
|
103 Participants
|
107 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-23F ≥ 0.15 µg/mL, Month 11
|
98 Participants
|
104 Participants
|
101 Participants
|
106 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-1 ≥ 0.15 µg/mL, Month 10
|
72 Participants
|
57 Participants
|
65 Participants
|
64 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-1 ≥ 0.35 µg/mL, Month 10
|
24 Participants
|
10 Participants
|
21 Participants
|
20 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-1 ≥ 0.15 µg/mL, Month 11
|
99 Participants
|
103 Participants
|
104 Participants
|
106 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-1 ≥ 0.35 µg/mL, Month 11
|
97 Participants
|
101 Participants
|
102 Participants
|
104 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-4 ≥ 0.15 µg/mL, Month 11
|
100 Participants
|
104 Participants
|
104 Participants
|
107 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-4 ≥ 0.35 µg/mL, Month 11
|
99 Participants
|
104 Participants
|
104 Participants
|
107 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-5 ≥ 0.15 µg/mL, Month 11
|
98 Participants
|
101 Participants
|
101 Participants
|
104 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-5 ≥ 0.35 µg/mL, Month 11
|
95 Participants
|
96 Participants
|
92 Participants
|
96 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-6B ≥ 0.15 µg/mL, Month 10
|
104 Participants
|
103 Participants
|
96 Participants
|
104 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-6B ≥ 0.35 µg/mL, Month 10
|
83 Participants
|
83 Participants
|
71 Participants
|
84 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-6B ≥ 0.15 µg/mL, Month 11
|
100 Participants
|
104 Participants
|
103 Participants
|
106 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-6B ≥ 0.35 µg/mL, Month 11
|
100 Participants
|
104 Participants
|
103 Participants
|
105 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-7F ≥ 0.15 µg/mL, Month 10
|
106 Participants
|
104 Participants
|
98 Participants
|
103 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-7F ≥ 0.15 µg/mL, Month 11
|
100 Participants
|
104 Participants
|
104 Participants
|
107 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-7F ≥ 0.35 µg/mL, Month 11
|
100 Participants
|
104 Participants
|
104 Participants
|
107 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-9V ≥ 0.15 µg/mL, Month 10
|
88 Participants
|
89 Participants
|
81 Participants
|
82 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-9V ≥ 0.35 µg/mL, Month 10
|
43 Participants
|
33 Participants
|
42 Participants
|
30 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-9V ≥ 0.15 µg/mL, Month 11
|
100 Participants
|
104 Participants
|
104 Participants
|
107 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-14 ≥ 0.15 µg/mL, Month 10
|
106 Participants
|
106 Participants
|
102 Participants
|
106 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-14 ≥ 0.15 µg/mL, Month 11
|
100 Participants
|
104 Participants
|
104 Participants
|
107 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-14 ≥ 0.35 µg/mL, Month 11
|
100 Participants
|
104 Participants
|
104 Participants
|
107 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-18C ≥ 0.15 µg/mL, Month 10
|
97 Participants
|
101 Participants
|
82 Participants
|
89 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-18C ≥ 0.35 µg/mL, Month 11
|
100 Participants
|
104 Participants
|
103 Participants
|
106 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-19F ≥ 0.15 µg/mL, Month 10
|
106 Participants
|
107 Participants
|
102 Participants
|
107 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-19F ≥ 0.35 µg/mL, Month 10
|
103 Participants
|
102 Participants
|
96 Participants
|
98 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-19F ≥ 0.15 µg/mL, Month 11
|
100 Participants
|
104 Participants
|
104 Participants
|
107 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-19F ≥ 0.35 µg/mL, Month 11
|
100 Participants
|
104 Participants
|
104 Participants
|
107 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-23F ≥ 0.15 µg/mL, Month 10
|
102 Participants
|
101 Participants
|
94 Participants
|
103 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-23F ≥ 0.35 µg/mL, Month 10
|
63 Participants
|
63 Participants
|
58 Participants
|
61 Participants
|
|
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Anti-23F ≥ 0.35 µg/mL, Month 11
|
98 Participants
|
104 Participants
|
101 Participants
|
106 Participants
|
SECONDARY outcome
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.
Anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in µg/mL.
Outcome measures
| Measure |
Menjugate Group
n=106 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=110 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=104 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=107 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-1, Month 11
|
2.18 µg/mL
Interval 1.81 to 2.64
|
1.72 µg/mL
Interval 1.46 to 2.03
|
2.03 µg/mL
Interval 1.72 to 2.41
|
1.67 µg/mL
Interval 1.39 to 2.01
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-1, Month 10
|
0.20 µg/mL
Interval 0.17 to 0.23
|
0.15 µg/mL
Interval 0.13 to 0.17
|
0.19 µg/mL
Interval 0.16 to 0.22
|
0.17 µg/mL
Interval 0.15 to 0.2
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-4, Month 10
|
0.31 µg/mL
Interval 0.27 to 0.37
|
0.25 µg/mL
Interval 0.22 to 0.28
|
0.27 µg/mL
Interval 0.23 to 0.32
|
0.27 µg/mL
Interval 0.23 to 0.32
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-4, Month 11
|
2.86 µg/mL
Interval 2.46 to 3.34
|
2.12 µg/mL
Interval 1.87 to 2.4
|
2.42 µg/mL
Interval 2.11 to 2.78
|
2.16 µg/mL
Interval 1.86 to 2.51
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-5, Month 10
|
0.30 µg/mL
Interval 0.26 to 0.35
|
0.27 µg/mL
Interval 0.23 to 0.3
|
0.32 µg/mL
Interval 0.27 to 0.37
|
0.28 µg/mL
Interval 0.24 to 0.32
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-5, Month 11
|
0.95 µg/mL
Interval 0.83 to 1.09
|
0.84 µg/mL
Interval 0.74 to 0.97
|
0.89 µg/mL
Interval 0.78 to 1.02
|
0.87 µg/mL
Interval 0.76 to 1.0
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-6B, Month 10
|
0.68 µg/mL
Interval 0.58 to 0.8
|
0.59 µg/mL
Interval 0.51 to 0.69
|
0.62 µg/mL
Interval 0.52 to 0.73
|
0.64 µg/mL
Interval 0.54 to 0.76
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-6B, Month 11
|
3.70 µg/mL
Interval 3.18 to 4.29
|
3.20 µg/mL
Interval 2.79 to 3.68
|
2.91 µg/mL
Interval 2.49 to 3.41
|
3.02 µg/mL
Interval 2.57 to 3.56
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-7F, Month 10
|
0.57 µg/mL
Interval 0.5 to 0.66
|
0.46 µg/mL
Interval 0.4 to 0.52
|
0.50 µg/mL
Interval 0.44 to 0.57
|
0.52 µg/mL
Interval 0.45 to 0.61
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-7F, Month 11
|
3.38 µg/mL
Interval 2.94 to 3.89
|
2.78 µg/mL
Interval 2.43 to 3.17
|
2.89 µg/mL
Interval 2.53 to 3.3
|
2.88 µg/mL
Interval 2.51 to 3.31
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-9V, Month 10
|
0.28 µg/mL
Interval 0.24 to 0.32
|
0.25 µg/mL
Interval 0.22 to 0.28
|
0.27 µg/mL
Interval 0.23 to 0.33
|
0.23 µg/mL
Interval 0.2 to 0.27
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-9V, Month 11
|
1.47 µg/mL
Interval 1.27 to 1.71
|
1.33 µg/mL
Interval 1.18 to 1.49
|
1.49 µg/mL
Interval 1.3 to 1.7
|
1.31 µg/mL
Interval 1.15 to 1.49
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-14, Month 10
|
1.74 µg/mL
Interval 1.46 to 2.09
|
1.42 µg/mL
Interval 1.18 to 1.7
|
1.69 µg/mL
Interval 1.39 to 2.05
|
1.64 µg/mL
Interval 1.37 to 1.97
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-14, Month 11
|
9.75 µg/mL
Interval 8.36 to 11.38
|
7.94 µg/mL
Interval 6.85 to 9.2
|
8.51 µg/mL
Interval 7.2 to 10.07
|
7.63 µg/mL
Interval 6.62 to 8.79
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-18C, Month 10
|
0.39 µg/mL
Interval 0.33 to 0.46
|
0.38 µg/mL
Interval 0.33 to 0.44
|
0.33 µg/mL
Interval 0.27 to 0.4
|
0.33 µg/mL
Interval 0.28 to 0.39
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-18C, Month 11
|
3.08 µg/mL
Interval 2.65 to 3.58
|
2.78 µg/mL
Interval 2.44 to 3.17
|
2.30 µg/mL
Interval 2.0 to 2.64
|
2.10 µg/mL
Interval 1.84 to 2.39
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-19F, Month 10
|
1.34 µg/mL
Interval 1.13 to 1.59
|
1.10 µg/mL
Interval 0.94 to 1.29
|
1.22 µg/mL
Interval 1.04 to 1.45
|
1.26 µg/mL
Interval 1.05 to 1.52
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-19F, Month 11
|
9.74 µg/mL
Interval 8.2 to 11.58
|
8.43 µg/mL
Interval 7.35 to 9.66
|
9.55 µg/mL
Interval 8.23 to 11.09
|
8.06 µg/mL
Interval 6.88 to 9.46
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-23F, Month 10
|
0.47 µg/mL
Interval 0.4 to 0.56
|
0.41 µg/mL
Interval 0.35 to 0.48
|
0.39 µg/mL
Interval 0.34 to 0.46
|
0.45 µg/mL
Interval 0.39 to 0.53
|
|
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-23F, Month 11
|
4.24 µg/mL
Interval 3.6 to 5.0
|
3.73 µg/mL
Interval 3.3 to 4.21
|
3.74 µg/mL
Interval 3.23 to 4.34
|
3.73 µg/mL
Interval 3.19 to 4.35
|
SECONDARY outcome
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.
The cut-off value for anti-D and anti-T concentrations was greater than or equal to (≥) 0.1 IU/mL
Outcome measures
| Measure |
Menjugate Group
n=123 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=115 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=117 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=113 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off Value
Anti-D, Month 0
|
56 Participants
|
39 Participants
|
37 Participants
|
43 Participants
|
|
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off Value
Anti-D, Month 3
|
123 Participants
|
115 Participants
|
117 Participants
|
113 Participants
|
|
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off Value
Anti-T, Month 0
|
107 Participants
|
91 Participants
|
104 Participants
|
91 Participants
|
|
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off Value
Anti-T, Month 3
|
123 Participants
|
114 Participants
|
117 Participants
|
113 Participants
|
SECONDARY outcome
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Outcome measures
| Measure |
Menjugate Group
n=123 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=115 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=117 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=113 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Anti-D and Anti-T Antibody Concentrations
Anti-D, Month 0
|
0.133 IU/mL
Interval 0.108 to 0.165
|
0.093 IU/mL
Interval 0.078 to 0.112
|
0.092 IU/mL
Interval 0.077 to 0.11
|
0.098 IU/mL
Interval 0.082 to 0.117
|
|
Anti-D and Anti-T Antibody Concentrations
Anti-D, Month 3
|
3.005 IU/mL
Interval 2.657 to 3.4
|
2.488 IU/mL
Interval 2.169 to 2.855
|
2.171 IU/mL
Interval 1.893 to 2.49
|
2.64 IU/mL
Interval 2.274 to 3.065
|
|
Anti-D and Anti-T Antibody Concentrations
Anti-T, Month 0
|
0.727 IU/mL
Interval 0.581 to 0.909
|
0.5 IU/mL
Interval 0.387 to 0.647
|
0.484 IU/mL
Interval 0.393 to 0.596
|
0.496 IU/mL
Interval 0.388 to 0.636
|
|
Anti-D and Anti-T Antibody Concentrations
Anti-T, Month 3
|
2.847 IU/mL
Interval 2.523 to 3.212
|
4.339 IU/mL
Interval 3.833 to 4.912
|
3.137 IU/mL
Interval 2.79 to 3.527
|
3.37 IU/mL
Interval 2.98 to 3.811
|
SECONDARY outcome
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.
The cut-off value for anti-D and anti-T concentrations was greater than or equal to (≥) 0.1 IU/mL
Outcome measures
| Measure |
Menjugate Group
n=119 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=118 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=116 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=112 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value
Anti-D, Month 10
|
116 Participants
|
113 Participants
|
98 Participants
|
98 Participants
|
|
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value
Anti-D, Month 11
|
118 Participants
|
118 Participants
|
116 Participants
|
111 Participants
|
|
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value
Anti-T, Month 10
|
118 Participants
|
117 Participants
|
114 Participants
|
111 Participants
|
|
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value
Anti-T, Month 11
|
118 Participants
|
118 Participants
|
116 Participants
|
111 Participants
|
SECONDARY outcome
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Outcome measures
| Measure |
Menjugate Group
n=119 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=118 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=116 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=112 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Anti-D and Anti-T Antibody Concentrations
Anti-T, Month 11
|
8.400 IU/mL
Interval 7.285 to 9.685
|
13.016 IU/mL
Interval 11.64 to 14.554
|
10.234 IU/mL
Interval 9.128 to 11.475
|
11.004 IU/mL
Interval 9.721 to 12.456
|
|
Anti-D and Anti-T Antibody Concentrations
Anti-D, Month 10
|
0.507 IU/mL
Interval 0.433 to 0.594
|
0.379 IU/mL
Interval 0.327 to 0.44
|
0.292 IU/mL
Interval 0.246 to 0.348
|
0.325 IU/mL
Interval 0.272 to 0.389
|
|
Anti-D and Anti-T Antibody Concentrations
Anti-D, Month 11
|
9.078 IU/mL
Interval 7.959 to 10.354
|
6.437 IU/mL
Interval 5.589 to 7.413
|
5.032 IU/mL
Interval 4.337 to 5.838
|
5.438 IU/mL
Interval 4.6 to 6.43
|
|
Anti-D and Anti-T Antibody Concentrations
Anti-T, Month 10
|
0.684 IU/mL
Interval 0.59 to 0.793
|
0.956 IU/mL
Interval 0.835 to 1.094
|
0.832 IU/mL
Interval 0.739 to 0.937
|
0.780 IU/mL
Interval 0.677 to 0.898
|
SECONDARY outcome
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.
The cut-off value for anti-PT, anti-FHA and anti-PRN concentrations was greater than or equal to (≥) 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Menjugate Group
n=123 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=115 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=117 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=112 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off Value
Anti-PT, Month 0
|
28 Participants
|
31 Participants
|
23 Participants
|
32 Participants
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off Value
Anti-PT, Month 3
|
122 Participants
|
115 Participants
|
117 Participants
|
111 Participants
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off Value
Anti-FHA, Month 0
|
93 Participants
|
78 Participants
|
83 Participants
|
85 Participants
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off Value
Anti-FHA, Month 3
|
123 Participants
|
115 Participants
|
117 Participants
|
111 Participants
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off Value
Anti-PRN, Month 0
|
44 Participants
|
32 Participants
|
31 Participants
|
39 Participants
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off Value
Anti-PRN, Month 3
|
122 Participants
|
115 Participants
|
117 Participants
|
112 Participants
|
SECONDARY outcome
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in EL.U/mL.
Outcome measures
| Measure |
Menjugate Group
n=123 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=115 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=117 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=112 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PT, Month 0
|
3.6 EL.U/mL
Interval 3.2 to 4.2
|
4.1 EL.U/mL
Interval 3.5 to 4.9
|
3.4 EL.U/mL
Interval 3.0 to 3.8
|
3.9 EL.U/mL
Interval 3.3 to 4.5
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PT, Month 3
|
56.5 EL.U/mL
Interval 50.5 to 63.1
|
56.4 EL.U/mL
Interval 50.6 to 63.0
|
52.7 EL.U/mL
Interval 46.5 to 59.8
|
56.3 EL.U/mL
Interval 49.5 to 64.0
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-FHA, Month 0
|
11.4 EL.U/mL
Interval 9.4 to 13.9
|
11.9 EL.U/mL
Interval 9.4 to 15.1
|
9.7 EL.U/mL
Interval 8.0 to 11.9
|
13.2 EL.U/mL
Interval 10.7 to 16.4
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-FHA, Month 3
|
139.1 EL.U/mL
Interval 123.2 to 157.1
|
132 EL.U/mL
Interval 115.1 to 151.3
|
124.3 EL.U/mL
Interval 109.0 to 141.8
|
149.2 EL.U/mL
Interval 131.2 to 169.6
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PRN, Month 0
|
4.6 EL.U/mL
Interval 3.9 to 5.4
|
4.7 EL.U/mL
Interval 3.8 to 5.9
|
4 EL.U/mL
Interval 3.4 to 4.7
|
5 EL.U/mL
Interval 4.0 to 6.2
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PRN, Month 3
|
118.2 EL.U/mL
Interval 101.5 to 137.7
|
132 EL.U/mL
Interval 113.6 to 153.5
|
122 EL.U/mL
Interval 104.1 to 143.1
|
134.9 EL.U/mL
Interval 119.0 to 152.9
|
SECONDARY outcome
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.
The cut-off value for anti-PT, anti-FHA and anti-PRN concentrations was greater than or equal to (≥) 5 EL.U/mL.
Outcome measures
| Measure |
Menjugate Group
n=119 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=118 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=116 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=112 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off Value
Anti-PT, Month 10
|
104 Participants
|
102 Participants
|
100 Participants
|
94 Participants
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off Value
Anti-PT, Month 11
|
116 Participants
|
116 Participants
|
110 Participants
|
109 Participants
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off Value
Anti-FHA, Month 10
|
118 Participants
|
115 Participants
|
112 Participants
|
106 Participants
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off Value
Anti-FHA, Month 11
|
116 Participants
|
116 Participants
|
113 Participants
|
111 Participants
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off Value
Anti-PRN, Month 10
|
109 Participants
|
105 Participants
|
105 Participants
|
98 Participants
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off Value
Anti-PRN, Month 11
|
118 Participants
|
118 Participants
|
116 Participants
|
110 Participants
|
SECONDARY outcome
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in EL.U/mL.
Outcome measures
| Measure |
Menjugate Group
n=119 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=118 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=116 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=112 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PT, Month 10
|
13.1 EL.U/mL
Interval 11.1 to 15.4
|
11.4 EL.U/mL
Interval 9.9 to 13.3
|
11.0 EL.U/mL
Interval 9.4 to 12.9
|
11.1 EL.U/mL
Interval 9.4 to 13.1
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PT, Month 11
|
84.7 EL.U/mL
Interval 73.5 to 97.5
|
82.7 EL.U/mL
Interval 72.5 to 94.4
|
82.5 EL.U/mL
Interval 71.9 to 94.7
|
78.2 EL.U/mL
Interval 67.8 to 90.2
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-FHA, Month 10
|
37.4 EL.U/mL
Interval 32.1 to 43.5
|
34.9 EL.U/mL
Interval 29.8 to 40.9
|
34.5 EL.U/mL
Interval 29.6 to 40.2
|
33.1 EL.U/mL
Interval 27.5 to 39.8
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-FHA, Month 11
|
305.9 EL.U/mL
Interval 269.0 to 347.8
|
302.9 EL.U/mL
Interval 266.8 to 343.9
|
285.5 EL.U/mL
Interval 250.6 to 325.4
|
296.3 EL.U/mL
Interval 258.5 to 339.7
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PRN, Month 10
|
19.9 EL.U/mL
Interval 16.5 to 23.9
|
17.9 EL.U/mL
Interval 14.8 to 21.6
|
17.9 EL.U/mL
Interval 14.8 to 21.6
|
15.7 EL.U/mL
Interval 13.1 to 18.8
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PRN, Month 11
|
291.7 EL.U/mL
Interval 246.1 to 345.7
|
334.3 EL.U/mL
Interval 282.9 to 395.1
|
283.7 EL.U/mL
Interval 233.9 to 344.1
|
290.8 EL.U/mL
Interval 242.5 to 348.7
|
SECONDARY outcome
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.
The cut-off values for anti-HBs concentrations were greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL) and ≥ 100 mIU/mL.
Outcome measures
| Measure |
Menjugate Group
n=97 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=93 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=98 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=84 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Values
Anti-HBs ≥ 100 mIU/mL, Month 0
|
14 Participants
|
8 Participants
|
17 Participants
|
14 Participants
|
|
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Values
Anti-HBs ≥ 10 mIU/mL, Month 0
|
39 Participants
|
28 Participants
|
33 Participants
|
34 Participants
|
|
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Values
Anti-HBs ≥ 10 mIU/mL, Month 3
|
94 Participants
|
79 Participants
|
85 Participants
|
84 Participants
|
|
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Values
Anti-HBs ≥ 100 mIU/mL, Month 3
|
89 Participants
|
73 Participants
|
74 Participants
|
79 Participants
|
SECONDARY outcome
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
Menjugate Group
n=97 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=93 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=98 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=84 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Anti-HBs Antibody Concentrations
Anti-HBs, Month 0
|
11.3 mIU/mL
Interval 7.7 to 16.7
|
7.5 mIU/mL
Interval 5.4 to 10.5
|
12.0 mIU/mL
Interval 7.6 to 18.7
|
13.7 mIU/mL
Interval 8.4 to 22.4
|
|
Anti-HBs Antibody Concentrations
Anti-HBs, Month 3
|
848.3 mIU/mL
Interval 663.7 to 1084.1
|
729.5 mIU/mL
Interval 530.3 to 1003.5
|
692.3 mIU/mL
Interval 513.2 to 934.0
|
732.2 mIU/mL
Interval 555.1 to 965.8
|
SECONDARY outcome
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.
The cut-off values for anti-HBs concentrations were greater than or equal to (≥) 10 mIU/mL and ≥ 100 mIU/mL.
Outcome measures
| Measure |
Menjugate Group
n=103 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=100 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=98 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=97 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Values
Anti-HBs ≥ 10 mIU/mL, Month 10
|
96 Participants
|
94 Participants
|
91 Participants
|
86 Participants
|
|
Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Values
Anti-HBs ≥ 10 mIU/mL, Month 11
|
103 Participants
|
100 Participants
|
95 Participants
|
97 Participants
|
|
Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Values
Anti-HBs ≥ 100 mIU/mL, Month 10
|
75 Participants
|
65 Participants
|
67 Participants
|
58 Participants
|
|
Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Values
Anti-HBs ≥ 100 mIU/mL, Month 11
|
102 Participants
|
97 Participants
|
93 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
Menjugate Group
n=103 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=100 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=98 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=97 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Anti-HBs Antibody Concentrations
Anti-HBs, Month 10
|
196.6 mIU/mL
Interval 141.6 to 273.1
|
141.9 mIU/mL
Interval 106.5 to 189.0
|
150.5 mIU/mL
Interval 111.4 to 203.3
|
138.2 mIU/mL
Interval 99.3 to 192.3
|
|
Anti-HBs Antibody Concentrations
Anti-HBs, Month 11
|
4866.4 mIU/mL
Interval 3723.5 to 6360.1
|
3878.7 mIU/mL
Interval 2861.7 to 5257.3
|
3624.9 mIU/mL
Interval 2570.0 to 5112.8
|
4129.8 mIU/mL
Interval 3095.4 to 5509.8
|
SECONDARY outcome
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.
The cut-off values for anti-PRP antibody concentrations were greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL) and ≥ 1.0 µg/mL.
Outcome measures
| Measure |
Menjugate Group
n=123 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=114 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=119 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=113 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off Values
Anti-PRP ≥ 0.15 µg/mL, Month 0
|
46 Participants
|
47 Participants
|
46 Participants
|
55 Participants
|
|
Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off Values
Anti-PRP ≥ 0.15 µg/mL, Month 3
|
121 Participants
|
113 Participants
|
119 Participants
|
113 Participants
|
|
Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off Values
Anti-PRP ≥ 1.0 µg/mL, Month 0
|
10 Participants
|
7 Participants
|
9 Participants
|
19 Participants
|
|
Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off Values
Anti-PRP ≥ 1.0 µg/mL, Month 3
|
94 Participants
|
106 Participants
|
106 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
Menjugate Group
n=123 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=114 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=119 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=113 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Anti-PRP Antibody Concentrations
Anti-PRP, Month 0
|
0.162 µg/mL
Interval 0.132 to 0.198
|
0.162 µg/mL
Interval 0.133 to 0.196
|
0.158 µg/mL
Interval 0.131 to 0.191
|
0.213 µg/mL
Interval 0.168 to 0.27
|
|
Anti-PRP Antibody Concentrations
Anti-PRP, Month 3
|
2.752 µg/mL
Interval 2.144 to 3.534
|
4.662 µg/mL
Interval 3.788 to 5.739
|
4.011 µg/mL
Interval 3.275 to 4.912
|
3.573 µg/mL
Interval 2.946 to 4.334
|
SECONDARY outcome
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.
The cut-off values for anti-PRP antibody concentrations were greater than or equal to (≥) 0.15 µg/mL and ≥ 1.0 µg/mL.
Outcome measures
| Measure |
Menjugate Group
n=119 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=118 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=116 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=112 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off Values
Anti-PRP ≥ 0.15 µg/mL, Month 10
|
91 Participants
|
100 Participants
|
92 Participants
|
91 Participants
|
|
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off Values
Anti-PRP ≥ 0.15 µg/mL, Month 11
|
119 Participants
|
118 Participants
|
116 Participants
|
112 Participants
|
|
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off Values
Anti-PRP ≥ 1.0 µg/mL, Month 10
|
40 Participants
|
31 Participants
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off Values
Anti-PRP ≥ 1.0 µg/mL, Month 11
|
119 Participants
|
114 Participants
|
113 Participants
|
112 Participants
|
SECONDARY outcome
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
Menjugate Group
n=119 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=118 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=116 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=112 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Anti-PRP Antibody Concentrations
Anti-PRP, Month 10
|
0.535 µg/mL
Interval 0.404 to 0.707
|
0.535 µg/mL
Interval 0.427 to 0.671
|
0.378 µg/mL
Interval 0.308 to 0.464
|
0.400 µg/mL
Interval 0.324 to 0.494
|
|
Anti-PRP Antibody Concentrations
Anti-PRP, Month 11
|
22.879 µg/mL
Interval 18.147 to 28.847
|
23.973 µg/mL
Interval 19.194 to 29.941
|
17.350 µg/mL
Interval 14.124 to 21.313
|
17.519 µg/mL
Interval 14.041 to 21.859
|
SECONDARY outcome
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.
The cut-off value for anti-poliovirus type 1, 2 and 3 antibody concentrations was greater than or equal to (≥) 1:8.
Outcome measures
| Measure |
Menjugate Group
n=90 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=86 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=93 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=83 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value
Anti-Polio 1, Month 0
|
54 Participants
|
46 Participants
|
52 Participants
|
46 Participants
|
|
Number of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value
Anti-Polio 1, Month 3
|
89 Participants
|
84 Participants
|
91 Participants
|
83 Participants
|
|
Number of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value
Anti-Polio 2, Month 0
|
44 Participants
|
41 Participants
|
39 Participants
|
40 Participants
|
|
Number of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value
Anti-Polio 2, Month 3
|
81 Participants
|
70 Participants
|
81 Participants
|
70 Participants
|
|
Number of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value
Anti-Polio 3, Month 0
|
11 Participants
|
23 Participants
|
21 Participants
|
21 Participants
|
|
Number of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value
Anti-Polio 3, Month 3
|
87 Participants
|
77 Participants
|
93 Participants
|
79 Participants
|
SECONDARY outcome
Timeframe: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 1, 2 and 3 (Day 0 to Month 2) and with the blood sample schedule for Visit 4 (Month 3), as assessed for a randomized subset of 25% of subjects.
Antibody titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Menjugate Group
n=90 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=86 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=93 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=83 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-Polio 1, Month 0
|
28.1 Titers
Interval 20.1 to 39.3
|
30.7 Titers
Interval 21.5 to 43.9
|
32.7 Titers
Interval 22.5 to 47.5
|
40.2 Titers
Interval 27.3 to 59.3
|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-Polio 1, Month 3
|
424.1 Titers
Interval 323.1 to 556.6
|
277.7 Titers
Interval 200.7 to 384.1
|
279.6 Titers
Interval 222.4 to 351.5
|
317.9 Titers
Interval 227.6 to 444.0
|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-Polio 2, Month 0
|
17.4 Titers
Interval 12.7 to 23.8
|
22.9 Titers
Interval 15.6 to 33.5
|
19.4 Titers
Interval 13.2 to 28.7
|
28 Titers
Interval 18.4 to 42.5
|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-Polio 2, Month 3
|
274.5 Titers
Interval 202.1 to 372.8
|
232.7 Titers
Interval 160.8 to 336.6
|
225.2 Titers
Interval 173.2 to 292.6
|
244.8 Titers
Interval 173.3 to 345.9
|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-Polio 3, Month 0
|
5.9 Titers
Interval 4.7 to 7.5
|
14.2 Titers
Interval 8.8 to 22.8
|
11.5 Titers
Interval 7.6 to 17.5
|
11.7 Titers
Interval 7.8 to 17.5
|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-Polio 3, Month 3
|
674 Titers
Interval 525.5 to 864.5
|
494.3 Titers
Interval 347.4 to 703.3
|
642.7 Titers
Interval 478.7 to 862.8
|
675 Titers
Interval 486.3 to 936.9
|
SECONDARY outcome
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.
The cut-off value for anti-poliovirus type 1, 2 and 3 antibody concentrations was greater than or equal to (≥) 1:8.
Outcome measures
| Measure |
Menjugate Group
n=86 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=87 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=85 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=85 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value
Anti-Polio 1, Month 10
|
80 Participants
|
81 Participants
|
74 Participants
|
63 Participants
|
|
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value
Anti-Polio 1, Month 11
|
81 Participants
|
84 Participants
|
85 Participants
|
85 Participants
|
|
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value
Anti-Polio 2, Month 10
|
83 Participants
|
72 Participants
|
69 Participants
|
66 Participants
|
|
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value
Anti-Polio 2, Month 11
|
71 Participants
|
68 Participants
|
70 Participants
|
74 Participants
|
|
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value
Anti-Polio 3, Month 10
|
62 Participants
|
64 Participants
|
57 Participants
|
62 Participants
|
|
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value
Anti-Polio 3, Month 11
|
74 Participants
|
69 Participants
|
79 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all the evaluable subjects who complied with the vaccination schedule for Visit 5 (Month 10) and with blood sample schedule for Visit 6 (Month 11), as assessed for a randomized subset of 25% of subjects.
Antibody titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Menjugate Group
n=86 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=87 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=85 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=85 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-polio 2, Month 11
|
2068.0 Titers
Interval 1602.7 to 2668.5
|
1419.0 Titers
Interval 1088.4 to 1849.9
|
1205.7 Titers
Interval 902.2 to 1611.3
|
1306.3 Titers
Interval 985.1 to 1732.2
|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-polio 3, Month 11
|
2136.2 Titers
Interval 1688.1 to 2703.4
|
1852.2 Titers
Interval 1425.6 to 2406.4
|
1681.0 Titers
Interval 1285.1 to 2198.9
|
2167.8 Titers
Interval 1645.7 to 2855.6
|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-polio 1, Month 10
|
120.8 Titers
Interval 92.5 to 157.8
|
90.0 Titers
Interval 65.8 to 123.0
|
74.9 Titers
Interval 56.3 to 99.6
|
84.7 Titers
Interval 60.0 to 119.7
|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-polio 1, Month 11
|
1524.5 Titers
Interval 1214.9 to 1913.0
|
1217.7 Titers
Interval 956.5 to 1550.2
|
909.8 Titers
Interval 694.1 to 1192.6
|
1070.9 Titers
Interval 812.5 to 1411.4
|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-polio 2, Month 10
|
112.5 Titers
Interval 86.7 to 146.1
|
78.1 Titers
Interval 57.6 to 105.9
|
93.7 Titers
Interval 71.1 to 123.5
|
80.1 Titers
Interval 57.6 to 111.5
|
|
Anti-polio Type 1, 2 and 3 Antibody Titers
Anti-polio 3, Month 10
|
155.2 Titers
Interval 118.3 to 203.7
|
108.6 Titers
Interval 77.6 to 152.1
|
115.0 Titers
Interval 80.1 to 165.2
|
104.6 Titers
Interval 77.9 to 140.3
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. For the considered assay and time point data was reported only for the Primary Vaccination doses.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. For the Nimenrix 2, Menjugate and NeisVac-C groups, results corresponding to Dose 2 are for Infanrix hexa and Synflorix vaccination at Visit 2 (Month 1), while results corresponding to Dose 3 refer to the vaccination at Visit 3 (Month 2).
Outcome measures
| Measure |
Menjugate Group
n=509 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=518 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=518 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=523 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
|
225 Participants
|
210 Participants
|
211 Participants
|
206 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 3
|
180 Participants
|
193 Participants
|
168 Participants
|
180 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 3
|
13 Participants
|
9 Participants
|
9 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 3
|
11 Participants
|
13 Participants
|
8 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across doses
|
48 Participants
|
69 Participants
|
54 Participants
|
67 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Across doses
|
343 Participants
|
317 Participants
|
326 Participants
|
318 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across doses
|
27 Participants
|
24 Participants
|
15 Participants
|
11 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
|
230 Participants
|
214 Participants
|
212 Participants
|
210 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
23 Participants
|
29 Participants
|
23 Participants
|
37 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2
|
283 Participants
|
284 Participants
|
261 Participants
|
271 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1
|
243 Participants
|
233 Participants
|
247 Participants
|
243 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
28 Participants
|
34 Participants
|
32 Participants
|
33 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1
|
236 Participants
|
230 Participants
|
241 Participants
|
229 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
9 Participants
|
5 Participants
|
9 Participants
|
5 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
|
179 Participants
|
188 Participants
|
188 Participants
|
182 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
14 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
10 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
14 Participants
|
10 Participants
|
3 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 3
|
15 Participants
|
22 Participants
|
13 Participants
|
18 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 3
|
308 Participants
|
274 Participants
|
247 Participants
|
265 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 3
|
252 Participants
|
218 Participants
|
210 Participants
|
216 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Across doses
|
344 Participants
|
327 Participants
|
319 Participants
|
332 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Across doses
|
391 Participants
|
371 Participants
|
363 Participants
|
369 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Across doses
|
24 Participants
|
15 Participants
|
18 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7) post-meningococcal vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. No data was applicable for the Nimenrix 2 Group, Menjugate Group and NeisVac-C Group since meningococcal vaccine was not given in Dose 2.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Outcome measures
| Measure |
Menjugate Group
n=509 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=518 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=518 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=523 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Any Redness, Dose 3
|
214 Participants
|
197 Participants
|
162 Participants
|
169 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Grade 3 Redness, Dose 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Grade 3 Swelling, Dose 3
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Any Pain, Across doses
|
213 Participants
|
212 Participants
|
229 Participants
|
202 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Grade 3 Pain, Across doses
|
19 Participants
|
33 Participants
|
29 Participants
|
26 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Any Pain, Dose 1
|
158 Participants
|
157 Participants
|
161 Participants
|
155 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Grade 3 Redness, Dose 1
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Any Swelling, Dose 1
|
87 Participants
|
82 Participants
|
68 Participants
|
62 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Grade 3 Swelling, Dose 1
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Any Pain, Dose 2
|
0 Participants
|
0 Participants
|
125 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Grade 3 Pain, Dose 2
|
0 Participants
|
0 Participants
|
9 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Any Redness, Dose 2
|
0 Participants
|
0 Participants
|
131 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Grade 3 Redness, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Any Swelling, Dose 2
|
0 Participants
|
0 Participants
|
77 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Grade 3 Swelling, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Any Pain, Dose 3
|
130 Participants
|
142 Participants
|
106 Participants
|
124 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Grade 3 Pain, Dose 3
|
9 Participants
|
12 Participants
|
7 Participants
|
11 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Any Swelling, Dose 3
|
137 Participants
|
130 Participants
|
104 Participants
|
115 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Any Redness, Across doses
|
255 Participants
|
233 Participants
|
233 Participants
|
206 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Grade 3 Redness, Across doses
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Any Swelling, Across doses
|
175 Participants
|
164 Participants
|
154 Participants
|
136 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Grade 3 Swelling, Across doses
|
3 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Grade 3 Pain, Dose 1
|
12 Participants
|
24 Participants
|
18 Participants
|
17 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Any Redness, Dose 1
|
138 Participants
|
140 Participants
|
132 Participants
|
128 Participants
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7) post-Infanrix hexa vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. For the considered assay and time point data was reported only for the Primary Vaccination doses.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Outcome measures
| Measure |
Menjugate Group
n=509 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=518 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=518 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=523 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Any Swelling, Across doses
|
308 Participants
|
294 Participants
|
297 Participants
|
292 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Any Pain, Dose 1
|
208 Participants
|
210 Participants
|
212 Participants
|
202 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Grade 3 Pain, Dose 1
|
25 Participants
|
32 Participants
|
28 Participants
|
28 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Any Redness, Dose 1
|
191 Participants
|
192 Participants
|
201 Participants
|
190 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Grade 3 Redness, Dose 1
|
6 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Any Swelling, Dose 1
|
128 Participants
|
147 Participants
|
148 Participants
|
148 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Grade 3 Swelling, Dose 1
|
13 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Any Pain, Dose 2
|
219 Participants
|
198 Participants
|
184 Participants
|
200 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Grade 3 Pain, Dose 2
|
22 Participants
|
27 Participants
|
18 Participants
|
34 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Any Redness, Dose 2
|
264 Participants
|
265 Participants
|
232 Participants
|
250 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Grade 3 Redness, Dose 2
|
10 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Any Swelling, Dose 2
|
208 Participants
|
195 Participants
|
182 Participants
|
185 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Grade 3 Swelling, Dose 2
|
13 Participants
|
10 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Any Pain, Dose 3
|
153 Participants
|
175 Participants
|
144 Participants
|
159 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Grade 3 Pain, Dose 3
|
11 Participants
|
19 Participants
|
9 Participants
|
14 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Any Redness, Dose 3
|
272 Participants
|
247 Participants
|
228 Participants
|
243 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Grade 3 Redness, Dose 3
|
11 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Any Swelling, Dose 3
|
227 Participants
|
197 Participants
|
191 Participants
|
200 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Grade 3 Swelling, Dose 3
|
11 Participants
|
11 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Any Pain, Across doses
|
314 Participants
|
310 Participants
|
289 Participants
|
311 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Grade 3 Pain, Across doses
|
43 Participants
|
63 Participants
|
44 Participants
|
58 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Any Redness, Across doses
|
358 Participants
|
349 Participants
|
336 Participants
|
344 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Grade 3 Redness, Across doses
|
19 Participants
|
10 Participants
|
13 Participants
|
11 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Grade 3 Swelling, Across doses
|
25 Participants
|
21 Participants
|
12 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7) post-Synflorix vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets. For the considered assay and time point data was reported only for the primary vaccination doses.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Outcome measures
| Measure |
Menjugate Group
n=509 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=518 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=518 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=523 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Any Pain, Dose 1
|
217 Participants
|
195 Participants
|
218 Participants
|
201 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Grade 3 Pain, Dose 1
|
26 Participants
|
32 Participants
|
29 Participants
|
26 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Any Redness, Dose 1
|
196 Participants
|
183 Participants
|
209 Participants
|
184 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Grade 3 Redness, Dose 1
|
5 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Any Swelling, Dose 1
|
130 Participants
|
120 Participants
|
135 Participants
|
136 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Grade 3 Swelling, Dose 1
|
10 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Any Pain, Dose 2
|
203 Participants
|
189 Participants
|
179 Participants
|
186 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Grade 3 Pain, Dose 2
|
19 Participants
|
25 Participants
|
20 Participants
|
31 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Any Redness, Dose 2
|
225 Participants
|
235 Participants
|
197 Participants
|
216 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Grade 3 Redness, Dose 2
|
5 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Any Swelling, Dose 2
|
156 Participants
|
155 Participants
|
154 Participants
|
162 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Grade 3 Swelling, Dose 2
|
8 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Any Pain, Dose 3
|
132 Participants
|
150 Participants
|
129 Participants
|
152 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Grade 3 Pain, Dose 3
|
10 Participants
|
18 Participants
|
10 Participants
|
13 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Any Redness, Dose 3
|
227 Participants
|
209 Participants
|
173 Participants
|
213 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Grade 3 Redness, Dose 3
|
6 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Any Swelling, Dose 3
|
164 Participants
|
146 Participants
|
136 Participants
|
152 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Grade 3 Swelling, Dose 3
|
6 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Any Pain, Across doses
|
312 Participants
|
291 Participants
|
285 Participants
|
304 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Grade 3 Pain, Across doses
|
41 Participants
|
61 Participants
|
46 Participants
|
54 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Any Redness, Across doses
|
331 Participants
|
316 Participants
|
297 Participants
|
322 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Grade 3 Redness, Across doses
|
12 Participants
|
7 Participants
|
8 Participants
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Any Swelling, Across doses
|
262 Participants
|
237 Participants
|
247 Participants
|
259 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Grade 3 Swelling, Across doses
|
16 Participants
|
13 Participants
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7) post-meningococcal booster vaccination periodPopulation: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Outcome measures
| Measure |
Menjugate Group
n=496 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=503 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=491 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=510 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Any Pain
|
203 Participants
|
181 Participants
|
191 Participants
|
203 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Grade 3 Pain
|
31 Participants
|
18 Participants
|
24 Participants
|
23 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Any Redness
|
213 Participants
|
228 Participants
|
186 Participants
|
221 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Grade 3 Redness
|
5 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Any Swelling
|
158 Participants
|
165 Participants
|
133 Participants
|
152 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Grade 3 Swelling
|
2 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7) post-Infanrix™ hexa booster vaccination periodPopulation: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Outcome measures
| Measure |
Menjugate Group
n=495 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=504 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=491 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=510 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Any Pain
|
242 Participants
|
221 Participants
|
240 Participants
|
241 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Grade Pain
|
39 Participants
|
23 Participants
|
35 Participants
|
33 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Any Redness
|
282 Participants
|
280 Participants
|
259 Participants
|
286 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Grade 3 Redness
|
32 Participants
|
22 Participants
|
29 Participants
|
24 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Any Swelling
|
244 Participants
|
240 Participants
|
212 Participants
|
226 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Grade 3 Swelling
|
17 Participants
|
14 Participants
|
20 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Within 31-days (Days 0-30) post-each primary vaccination dosePopulation: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Menjugate Group
n=516 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=527 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=528 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=524 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
|
291 Participants
|
280 Participants
|
293 Participants
|
273 Participants
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7) post-Synflorix™ booster vaccination periodPopulation: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Outcome measures
| Measure |
Menjugate Group
n=495 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=504 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=491 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=510 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ Vaccination
Any Pain
|
227 Participants
|
205 Participants
|
212 Participants
|
215 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ Vaccination
Grade 3 Pain
|
33 Participants
|
26 Participants
|
36 Participants
|
33 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ Vaccination
Any Redness
|
242 Participants
|
250 Participants
|
219 Participants
|
243 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ Vaccination
Grade 3 Redness
|
20 Participants
|
9 Participants
|
14 Participants
|
9 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ Vaccination
Any Swelling
|
189 Participants
|
193 Participants
|
173 Participants
|
174 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ Vaccination
Grade 3 Swelling
|
4 Participants
|
10 Participants
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as rectal temperature greater than or equal to (≥) 38 degrees Celsius (°C)\]. Any = occurrence of any general symptoms, regardless of their intensity grade or relationship to study vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Not eating at all. Grade 3 Temperature= temperature above 40.0 (°C). Related = symptom assessed by the investigator as related to the vaccination. For the Nimenrix 2, Menjugate and NeisVac-C groups, results corresponding to Dose 2 are for Infanrix™ hexa and Synflorix™ vaccination at Visit 2 (Month 1), while results corresponding to Dose 3 refer to the vaccination at Visit 3 (Month 2).
Outcome measures
| Measure |
Menjugate Group
n=509 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=518 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=518 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=523 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 1
|
213 Participants
|
235 Participants
|
199 Participants
|
206 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 1
|
196 Participants
|
219 Participants
|
188 Participants
|
208 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 1
|
9 Participants
|
8 Participants
|
12 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 1
|
111 Participants
|
117 Participants
|
95 Participants
|
106 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 1
|
170 Participants
|
183 Participants
|
166 Participants
|
162 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 1
|
122 Participants
|
144 Participants
|
128 Participants
|
119 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 2
|
137 Participants
|
132 Participants
|
133 Participants
|
123 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 2
|
158 Participants
|
144 Participants
|
146 Participants
|
145 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 2
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 2
|
116 Participants
|
110 Participants
|
107 Participants
|
105 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 3
|
13 Participants
|
14 Participants
|
21 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 3
|
271 Participants
|
262 Participants
|
259 Participants
|
279 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 3
|
32 Participants
|
39 Participants
|
37 Participants
|
30 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 3
|
164 Participants
|
174 Participants
|
165 Participants
|
178 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 3
|
159 Participants
|
154 Participants
|
149 Participants
|
176 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 3
|
10 Participants
|
9 Participants
|
14 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 3
|
83 Participants
|
90 Participants
|
88 Participants
|
94 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 3
|
112 Participants
|
114 Participants
|
106 Participants
|
127 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 3
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 3
|
79 Participants
|
89 Participants
|
71 Participants
|
88 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Across doses
|
370 Participants
|
377 Participants
|
376 Participants
|
365 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Across doses
|
40 Participants
|
47 Participants
|
45 Participants
|
41 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Across doses
|
235 Participants
|
237 Participants
|
235 Participants
|
231 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Across doses
|
439 Participants
|
441 Participants
|
419 Participants
|
436 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Across doses
|
86 Participants
|
104 Participants
|
109 Participants
|
83 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Across doses
|
311 Participants
|
325 Participants
|
302 Participants
|
304 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Across doses
|
307 Participants
|
312 Participants
|
295 Participants
|
325 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Across doses
|
22 Participants
|
22 Participants
|
28 Participants
|
23 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Across doses
|
186 Participants
|
182 Participants
|
180 Participants
|
194 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Across doses
|
277 Participants
|
275 Participants
|
272 Participants
|
274 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Across doses
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Across doses
|
208 Participants
|
220 Participants
|
203 Participants
|
208 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 1
|
163 Participants
|
178 Participants
|
163 Participants
|
167 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 1
|
17 Participants
|
34 Participants
|
22 Participants
|
22 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 1
|
285 Participants
|
297 Participants
|
298 Participants
|
282 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 1
|
355 Participants
|
364 Participants
|
329 Participants
|
337 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 1
|
45 Participants
|
54 Participants
|
54 Participants
|
41 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 2
|
319 Participants
|
320 Participants
|
328 Participants
|
312 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 2
|
231 Participants
|
211 Participants
|
232 Participants
|
210 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 2
|
17 Participants
|
12 Participants
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 2
|
44 Participants
|
48 Participants
|
52 Participants
|
35 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 2
|
194 Participants
|
212 Participants
|
208 Participants
|
198 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 2
|
183 Participants
|
179 Participants
|
164 Participants
|
185 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 2
|
6 Participants
|
7 Participants
|
10 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 2
|
93 Participants
|
106 Participants
|
95 Participants
|
103 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 3
|
197 Participants
|
193 Participants
|
181 Participants
|
194 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 3
|
109 Participants
|
112 Participants
|
112 Participants
|
115 Participants
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7) post-booster vaccination periodPopulation: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as rectal temperature greater than or equal to (≥) 38 degrees Celsius (°C)\]. Any = occurrence of any general symptoms, regardless of their intensity grade or relationship to study vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Not eating at all. Grade 3 Temperature= temperature above 40.0 (°C). Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Menjugate Group
n=496 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=504 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=491 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=510 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness
|
21 Participants
|
18 Participants
|
14 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness
|
119 Participants
|
125 Participants
|
125 Participants
|
129 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness
|
208 Participants
|
202 Participants
|
198 Participants
|
206 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability
|
284 Participants
|
297 Participants
|
284 Participants
|
296 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability
|
37 Participants
|
45 Participants
|
41 Participants
|
37 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability
|
181 Participants
|
186 Participants
|
180 Participants
|
197 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite
|
198 Participants
|
195 Participants
|
189 Participants
|
193 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite
|
23 Participants
|
27 Participants
|
12 Participants
|
21 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite
|
114 Participants
|
121 Participants
|
118 Participants
|
114 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature (Rectally)
|
186 Participants
|
170 Participants
|
187 Participants
|
180 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature (Rectally)
|
3 Participants
|
7 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature (Rectally)
|
122 Participants
|
125 Participants
|
133 Participants
|
132 Participants
|
SECONDARY outcome
Timeframe: Within 31-days (Days 0-30) post-booster vaccination periodPopulation: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Menjugate Group
n=503 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=506 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=497 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=511 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
|
164 Participants
|
167 Participants
|
179 Participants
|
185 Participants
|
SECONDARY outcome
Timeframe: Throughout the entire study (from Day 0 to Month 16)Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Menjugate Group
n=516 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=527 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=528 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=524 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
From Day 0 up to Month 1 post-primary vaccination
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Serious Adverse Events (SAEs)
From primary vaccination up to ESFU contact
|
45 Participants
|
52 Participants
|
54 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: From Booster vaccination (Month 10) up to Extended Safety Follow-Up (ESFU) (Month 16)Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Menjugate Group
n=503 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=506 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=497 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=511 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
14 Participants
|
17 Participants
|
14 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: During 31-days (Days 0-30) post-each primary vaccination dose (Day 0 to Month 3) and from primary vaccination up to ESFU (Month 16)Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase, who had filled in their symptom sheets.
NOCIs assessed included asthma, autoimmune disorders, type 1 diabetes and allergies.
Outcome measures
| Measure |
Menjugate Group
n=516 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=527 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=528 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=524 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
Day 0 - Day 30 after each primary dose
|
5 Participants
|
5 Participants
|
11 Participants
|
6 Participants
|
|
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
From primary vaccination up to ESFU contact
|
15 Participants
|
11 Participants
|
14 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: From Booster vaccination (Month 10 to Month 11) up to ESFU (Month 16)Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects during the booster phase, who had filled in their symptom sheets.
NOCIs assessed included asthma, autoimmune disorders, type 1 diabetes and allergies.
Outcome measures
| Measure |
Menjugate Group
n=503 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=506 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Nimenrix 3 Group
n=497 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=511 Participants
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
|
5 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Nimenrix 3 Group
Serious events: 54 serious events
Other events: 512 other events
Deaths: 0 deaths
Nimenrix 2 Group
Serious events: 56 serious events
Other events: 516 other events
Deaths: 0 deaths
Menjugate Group
Serious events: 45 serious events
Other events: 506 other events
Deaths: 0 deaths
NeisVac-C Group
Serious events: 52 serious events
Other events: 513 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nimenrix 3 Group
n=528 participants at risk
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=524 participants at risk
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Menjugate Group
n=516 participants at risk
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=527 participants at risk
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Cardiac disorders
Wolff-parkinson-white syndrome
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Congenital, familial and genetic disorders
Laryngomalacia
|
0.19%
1/528 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Congenital, familial and genetic disorders
Plagiocephaly
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.38%
2/524 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.57%
3/524 • Number of events 3 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Gastrointestinal disorders
Vomiting
|
0.38%
2/528 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
General disorders
Pyrexia
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.95%
5/524 • Number of events 5 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.57%
3/527 • Number of events 3 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Immune system disorders
Milk allergy
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Abscess
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Adenovirus infection
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Anal abscess
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Atypical pneumonia
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.38%
2/527 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Bronchiolitis
|
2.3%
12/528 • Number of events 12 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
1.9%
10/524 • Number of events 10 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
1.7%
9/516 • Number of events 9 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
2.7%
14/527 • Number of events 14 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Bronchitis
|
1.7%
9/528 • Number of events 11 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.76%
4/524 • Number of events 4 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
1.5%
8/527 • Number of events 9 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Conjunctivitis
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Croup infectious
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Encephalitis
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Epstein-barr virus infection
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Exanthema subitum
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Gastroenteritis
|
1.1%
6/528 • Number of events 6 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.57%
3/524 • Number of events 3 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.97%
5/516 • Number of events 5 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.57%
3/527 • Number of events 3 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.38%
2/528 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.38%
2/524 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.38%
2/527 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Genital candidiasis
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
H1n1 influenza
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Influenza
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Laryngitis
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Lung infection
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.38%
2/524 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Oral candidiasis
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Otitis media
|
0.57%
3/528 • Number of events 3 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.39%
2/516 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Otitis media acute
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.38%
2/527 • Number of events 3 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Pertussis
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Pharyngitis
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Pneumonia
|
0.76%
4/528 • Number of events 4 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.57%
3/524 • Number of events 3 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
1.2%
6/516 • Number of events 6 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.95%
5/527 • Number of events 5 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Pyelonephritis
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.76%
4/527 • Number of events 4 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.38%
2/528 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.57%
3/524 • Number of events 3 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.39%
2/516 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Sepsis
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Tonsillitis
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.76%
4/528 • Number of events 4 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.38%
2/524 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.39%
2/516 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Urinary tract infection
|
0.57%
3/528 • Number of events 3 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.38%
2/527 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Viral infection
|
0.38%
2/528 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Viral rash
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.78%
4/516 • Number of events 4 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.38%
2/527 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.38%
2/528 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebral haemangioma
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Nervous system disorders
Brain injury
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Nervous system disorders
Epilepsy
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Nervous system disorders
Febrile convulsion
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.38%
2/527 • Number of events 2 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Psychiatric disorders
Breath holding
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Reproductive system and breast disorders
Testicular retraction
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Respiratory, thoracic and mediastinal disorders
Apparent life threatening event
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.19%
1/528 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/516 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/524 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/527 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Vascular disorders
Kawasaki's disease
|
0.00%
0/528 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/524 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.00%
0/516 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
0.19%
1/527 • Number of events 1 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
Other adverse events
| Measure |
Nimenrix 3 Group
n=528 participants at risk
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.
|
Nimenrix 2 Group
n=524 participants at risk
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
Menjugate Group
n=516 participants at risk
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
NeisVac-C Group
n=527 participants at risk
Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.
|
|---|---|---|---|---|
|
Infections and infestations
Bronchiolitis
|
6.4%
34/528 • Number of events 39 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
5.5%
29/524 • Number of events 32 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
6.0%
31/516 • Number of events 33 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
7.0%
37/527 • Number of events 43 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Bronchitis
|
8.5%
45/528 • Number of events 49 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
5.9%
31/524 • Number of events 35 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
6.6%
34/516 • Number of events 37 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
9.1%
48/527 • Number of events 56 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Conjunctivitis
|
5.1%
27/528 • Number of events 28 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
4.0%
21/524 • Number of events 24 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
6.0%
31/516 • Number of events 32 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
5.9%
31/527 • Number of events 34 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
68.4%
361/528 • Number of events 692 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
70.0%
367/524 • Number of events 762 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
68.8%
355/516 • Number of events 738 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
70.2%
370/527 • Number of events 747 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Gastrointestinal disorders
Diarrhoea
|
6.4%
34/528 • Number of events 37 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
5.9%
31/524 • Number of events 39 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
6.2%
32/516 • Number of events 42 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
6.1%
32/527 • Number of events 35 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
77.8%
411/528 • Number of events 1036 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
78.6%
412/524 • Number of events 1079 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
83.7%
432/516 • Number of events 1139 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
78.2%
412/527 • Number of events 1100 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Gastroenteritis
|
5.9%
31/528 • Number of events 32 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
5.9%
31/524 • Number of events 32 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
4.1%
21/516 • Number of events 22 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
3.4%
18/527 • Number of events 18 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Psychiatric disorders
Irritability
|
84.5%
446/528 • Number of events 1205 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
87.2%
457/524 • Number of events 1230 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
88.2%
455/516 • Number of events 1238 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
87.3%
460/527 • Number of events 1247 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
25/528 • Number of events 30 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
5.3%
28/524 • Number of events 30 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
6.4%
33/516 • Number of events 42 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
5.7%
30/527 • Number of events 35 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
General disorders
Pain
|
73.1%
386/528 • Number of events 895 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
72.3%
379/524 • Number of events 899 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
76.4%
394/516 • Number of events 927 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
71.9%
379/527 • Number of events 892 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
General disorders
Pyrexia
|
65.9%
348/528 • Number of events 627 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
66.4%
348/524 • Number of events 647 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
67.6%
349/516 • Number of events 660 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
65.1%
343/527 • Number of events 645 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Rhinitis
|
6.2%
33/528 • Number of events 39 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
5.9%
31/524 • Number of events 34 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
7.8%
40/516 • Number of events 41 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
4.0%
21/527 • Number of events 24 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Nervous system disorders
Somnolence
|
75.4%
398/528 • Number of events 909 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
73.7%
386/524 • Number of events 892 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
77.3%
399/516 • Number of events 921 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
77.4%
408/527 • Number of events 903 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
General disorders
Swelling
|
71.2%
376/528 • Number of events 858 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
72.5%
380/524 • Number of events 864 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
75.8%
391/516 • Number of events 924 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
70.6%
372/527 • Number of events 890 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Infections and infestations
Upper respiratory tract infection
|
20.5%
108/528 • Number of events 146 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
22.5%
118/524 • Number of events 166 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
20.9%
108/516 • Number of events 162 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
19.5%
103/527 • Number of events 135 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
24/528 • Number of events 27 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
3.8%
20/524 • Number of events 22 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
5.0%
26/516 • Number of events 28 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
2.5%
13/527 • Number of events 15 • Solicited local and general symptoms: during the 8-day (Days 0-7) period after each vaccination. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) period after each vaccination. SAEs: throughout the entire study (Day 0-Extended Safety Follow-up at Month 16).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER