Trial Outcomes & Findings for Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study (NCT NCT00381615)
NCT ID: NCT00381615
Last Updated: 2015-10-09
Results Overview
Percentage of subjects fourfold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99 and NZ98/254 were measured at one month after third-dose and calculated respect to baseline titers.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
147 participants
Primary outcome timeframe
30 days after the third vaccination
Results posted on
2015-10-09
Participant Flow
Subjects were enrolled at three study centers in the United Kingdom (UK).
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
rMenB
Infants received 4 doses of recombinant meningococcal serogroup B (rMenB) vaccine without Outer Membrane Vesicle (OMV-NZ) at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of diphtheria-tetanus-acellular pertussis vaccine (DTaP-Hib-IPV) (at 2, 3, and 4 months) and Heptavalent Pneumococcal Conjugate (PC7) (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and Measles Mumps Rubella (MMR) (at 13 months).
|
rMenB+OMV
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
48
|
50
|
25
|
24
|
|
Overall Study
COMPLETED
|
44
|
45
|
24
|
22
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
1
|
2
|
Reasons for withdrawal
| Measure |
rMenB
Infants received 4 doses of recombinant meningococcal serogroup B (rMenB) vaccine without Outer Membrane Vesicle (OMV-NZ) at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of diphtheria-tetanus-acellular pertussis vaccine (DTaP-Hib-IPV) (at 2, 3, and 4 months) and Heptavalent Pneumococcal Conjugate (PC7) (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and Measles Mumps Rubella (MMR) (at 13 months).
|
rMenB+OMV
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Baseline characteristics by cohort
| Measure |
rMenB
n=48 Participants
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=50 Participants
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
n=25 Participants
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
n=24 Participants
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.0 Days
STANDARD_DEVIATION 3.4 • n=5 Participants
|
60.9 Days
STANDARD_DEVIATION 5.9 • n=7 Participants
|
60.4 Days
STANDARD_DEVIATION 5.9 • n=5 Participants
|
60.9 Days
STANDARD_DEVIATION 6.1 • n=4 Participants
|
60.2 Days
STANDARD_DEVIATION 5.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and one month after third-dose of infants seriesPopulation: Analysis was performed on the per protocol (PP) set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.
Immunogenicity was measured as percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, evaluated using serum bactericidal assay, before vaccination (baseline) and at one month after third-dose of Infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age.
Outcome measures
| Measure |
rMenB
n=46 Participants
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=46 Participants
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization
Strain 44/76-SL - Titer ≥1:4 - Baseline
|
11 Percentage of subjects
Interval 4.0 to 24.0
|
11 Percentage of subjects
Interval 4.0 to 24.0
|
—
|
—
|
|
Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization
Str. 44/76-SL-Titer ≥1:4- Post-3rd dose (N=36,39)
|
78 Percentage of subjects
Interval 61.0 to 90.0
|
87 Percentage of subjects
Interval 73.0 to 96.0
|
—
|
—
|
|
Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization
Strain 5/99 - Titer ≥1:4 - Baseline (N=42,43)
|
7 Percentage of subjects
Interval 1.0 to 19.0
|
14 Percentage of subjects
Interval 5.0 to 28.0
|
—
|
—
|
|
Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization
Str. 5/99 - Titer ≥1:4- Post-3rd dose (N=32,37)
|
100 Percentage of subjects
Interval 89.0 to 100.0
|
95 Percentage of subjects
Interval 82.0 to 99.0
|
—
|
—
|
|
Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization
Strain NZ98/254 - Titer ≥1:4 - Baseline (N=46,46)
|
4 Percentage of subjects
Interval 1.0 to 15.0
|
9 Percentage of subjects
Interval 2.0 to 21.0
|
—
|
—
|
|
Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization
Str. NZ98/254-Titer ≥1:4- Post-3rd dose (N=37,40)
|
5 Percentage of subjects
Interval 1.0 to 18.0
|
85 Percentage of subjects
Interval 70.0 to 94.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and one month after third-dose of infants seriesPopulation: Analysis was performed on the PP set.
The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, before vaccination (baseline) and at one month after third-dose of infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age.
Outcome measures
| Measure |
rMenB
n=46 Participants
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=46 Participants
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ
Strain 5/99 - Post-3rd dose (N=32,37)
|
159 titers
Interval 100.0 to 253.0
|
126 titers
Interval 77.0 to 205.0
|
—
|
—
|
|
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ
Strain NZ98/254 - Baseline (N=46,46)
|
1.23 titers
Interval 1.0 to 1.52
|
1.15 titers
Interval 1.02 to 1.29
|
—
|
—
|
|
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ
Strain 44/76-SL - Baseline
|
1.32 titers
Interval 1.05 to 1.66
|
1.4 titers
Interval 1.16 to 1.69
|
—
|
—
|
|
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ
Strain 44/76-SL - Post-3rd dose (N=36,39)
|
13 titers
Interval 8.11 to 22.0
|
30 titers
Interval 19.0 to 46.0
|
—
|
—
|
|
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ
Strain 5/99 - Baseline (N=42,43)
|
1.22 titers
Interval 0.98 to 1.52
|
1.43 titers
Interval 1.12 to 1.81
|
—
|
—
|
|
Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ
Strain NZ98/254 - Post-3rd dose (N=37,40)
|
1.16 titers
Interval 0.98 to 1.38
|
19 titers
Interval 11.0 to 33.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through day 7 after each vaccinationPopulation: Analysis was performed on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV administered at 2 months (vaccination 1), 4 months (vaccination 2), 6 months (vaccination 3) and 12 months (vaccination 4; vaccination 1 for Routine and Routine+OMV groups).
Outcome measures
| Measure |
rMenB
n=48 Participants
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=50 Participants
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
n=24 Participants
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
n=23 Participants
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV
Tenderness - Vaccination 1
|
17 Number of subjects
|
17 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV
Tenderness - Vaccination 2 (N=48,48,24,23)
|
10 Number of subjects
|
14 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV
Tenderness - Vaccination 3 (N=47,48,24,23)
|
10 Number of subjects
|
17 Number of subjects
|
6 Number of subjects
|
7 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV
Tenderness - Vaccination 4 (N=45,48,24,23)
|
10 Number of subjects
|
23 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV
Erythema - Vaccination 1
|
40 Number of subjects
|
42 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV
Erythema - Vaccination 2 (N=48,48,24,23)
|
43 Number of subjects
|
45 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV
Erythema - Vaccination 3 (N=47,48,24,23)
|
43 Number of subjects
|
44 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV
Erythema - Vaccination 4 (N=45,48,24,23)
|
43 Number of subjects
|
46 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV
Induration - Vaccination 1
|
15 Number of subjects
|
24 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV
Induration - Vaccination 2 (N=48,48,24,23)
|
13 Number of subjects
|
24 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV
Induration - Vaccination 3 (N=47,48,24,23)
|
20 Number of subjects
|
22 Number of subjects
|
10 Number of subjects
|
19 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV
Induration - Vaccination 4 (N=45,48,24,23)
|
22 Number of subjects
|
34 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
PRIMARY outcome
Timeframe: Day 1 through day 7 after each vaccinationPopulation: Analysis was performed on the safety set.
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of PC7 administered at 2 months (vaccination 1) and 4 months (vaccination 3).
Outcome measures
| Measure |
rMenB
n=48 Participants
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=50 Participants
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
n=25 Participants
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
n=24 Participants
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7
Tenderness - Vaccination 1
|
19 Number of subjects
|
21 Number of subjects
|
7 Number of subjects
|
10 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7
Tenderness - Vaccination 3 (N=48,48,25,24)
|
10 Number of subjects
|
12 Number of subjects
|
6 Number of subjects
|
6 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7
Erythema - Vaccination 1
|
38 Number of subjects
|
43 Number of subjects
|
24 Number of subjects
|
20 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7
Erythema - Vaccination 3 (N=48,48,25,24)
|
43 Number of subjects
|
42 Number of subjects
|
24 Number of subjects
|
22 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7
Induration - Vaccination 1
|
19 Number of subjects
|
21 Number of subjects
|
11 Number of subjects
|
13 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7
Induration - Vaccination 3 (N=48,48,25,24)
|
19 Number of subjects
|
19 Number of subjects
|
13 Number of subjects
|
16 Number of subjects
|
PRIMARY outcome
Timeframe: Day 1 through day 7 after each vaccinationPopulation: Analysis was performed on the safety set.
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of the pentavalent vaccine DTaP-Hib-IPV administered at 2 months (vaccination 1), 3 months (vaccination 2) and 4 months (vaccination 3).
Outcome measures
| Measure |
rMenB
n=48 Participants
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=50 Participants
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
n=25 Participants
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
n=24 Participants
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine
Tenderness - Vaccination 1
|
21 Number of subjects
|
22 Number of subjects
|
8 Number of subjects
|
14 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine
Tenderness - Vaccination 2 (N=48,49,25,24)
|
14 Number of subjects
|
8 Number of subjects
|
5 Number of subjects
|
5 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine
Tenderness - Vaccination 3 (N=48,48,25,24)
|
12 Number of subjects
|
12 Number of subjects
|
3 Number of subjects
|
6 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine
Erythema - Vaccination 1
|
37 Number of subjects
|
41 Number of subjects
|
24 Number of subjects
|
22 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine
Erythema - Vaccination 2 (N=48,49,25,24)
|
42 Number of subjects
|
44 Number of subjects
|
25 Number of subjects
|
22 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine
Erythema - Vaccination 3 (N=48,48,25,24)
|
41 Number of subjects
|
42 Number of subjects
|
24 Number of subjects
|
23 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine
Induration - Vaccination 1
|
19 Number of subjects
|
20 Number of subjects
|
10 Number of subjects
|
16 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine
Induration - Vaccination 2 (N=48,49,25,24)
|
17 Number of subjects
|
16 Number of subjects
|
8 Number of subjects
|
11 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine
Induration - Vaccination 3 (N=48,48,25,24)
|
23 Number of subjects
|
20 Number of subjects
|
13 Number of subjects
|
15 Number of subjects
|
PRIMARY outcome
Timeframe: Day 1 through day 7 after each vaccinationPopulation: Analysis was performed on the safety set.
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of MenC-CRM administered at 2 months (vaccination 1) and 5 months (vaccination 2). MenC-Hib was administered at 12 months of age (vaccination 3).
Outcome measures
| Measure |
rMenB
n=48 Participants
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=49 Participants
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
n=25 Participants
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
n=24 Participants
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib
Tenderness - Vaccination 1
|
7 Number of subjects
|
8 Number of subjects
|
7 Number of subjects
|
5 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib
Tenderness - Vaccination 2 (N=48,48,25,24)
|
7 Number of subjects
|
10 Number of subjects
|
3 Number of subjects
|
6 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib
Tenderness - Vaccination 3 (N=45,48,24,23)
|
8 Number of subjects
|
15 Number of subjects
|
5 Number of subjects
|
5 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib
Erythema - Vaccination 2 (N=48,48,25,24)
|
42 Number of subjects
|
43 Number of subjects
|
21 Number of subjects
|
21 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib
Erythema - Vaccination 3 (N=45,48,24,23)
|
44 Number of subjects
|
45 Number of subjects
|
22 Number of subjects
|
23 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib
Induration - Vaccination 2 (N=48,48,25,24)
|
13 Number of subjects
|
21 Number of subjects
|
11 Number of subjects
|
11 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib
Erythema - Vaccination 1
|
37 Number of subjects
|
44 Number of subjects
|
24 Number of subjects
|
21 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib
Induration - Vaccination 1
|
12 Number of subjects
|
16 Number of subjects
|
10 Number of subjects
|
7 Number of subjects
|
|
Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib
Induration - Vaccination 3 (N=45,48,24,23)
|
21 Number of subjects
|
24 Number of subjects
|
12 Number of subjects
|
16 Number of subjects
|
PRIMARY outcome
Timeframe: Day 1 through day 7 after each vaccinationPopulation: Analysis was performed on the safety set.
Safety was assessed as the number of subjects who reported solicited systemic reactions and other indicator of reactogenicity from day 1 through day 7 after each vaccination administered during study as follow: rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 2 months (vaccination 1), MenC-CRM, DTaP-Hib-IPV at 3 months (vaccination 2), rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 4 months (vaccination 3), MenC-CRM at 5 months (vaccination 4), rMenB vaccine with and without OMV at 6 months (vaccination 5; rMenB and rMenB+OMV groups only), rMenB vaccine with and without OMV at 12 months (vaccination 5; routine and routine+OMV groups only), and rMenB vaccine with and without OMV (vaccination 6; rMenB and rMenB+OMV groups only).
Outcome measures
| Measure |
rMenB
n=48 Participants
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=50 Participants
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
n=25 Participants
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
n=24 Participants
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Irritability - Vaccination 2 (N=48,49,25,24)
|
26 Number of subjects
|
29 Number of subjects
|
14 Number of subjects
|
13 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Irritability - Vaccination 3 (N=48,48,25,24)
|
27 Number of subjects
|
34 Number of subjects
|
13 Number of subjects
|
12 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Irritability - Vaccination 4 (N=48,48,25,24)
|
15 Number of subjects
|
15 Number of subjects
|
7 Number of subjects
|
6 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Unusual crying - Vaccination 1
|
11 Number of subjects
|
9 Number of subjects
|
8 Number of subjects
|
7 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Unusual crying - Vaccination 2 (N=48,49,25,24)
|
7 Number of subjects
|
6 Number of subjects
|
5 Number of subjects
|
1 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Change in eating habits - Vaccination 1
|
7 Number of subjects
|
13 Number of subjects
|
11 Number of subjects
|
5 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Change in eating habits- Vaccin 2 (N=48,49,25,24)
|
4 Number of subjects
|
6 Number of subjects
|
3 Number of subjects
|
1 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Change in eating habits- Vaccin 3 (N=48,48,25,24)
|
12 Number of subjects
|
9 Number of subjects
|
3 Number of subjects
|
4 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Diarrhea - Vaccination 1
|
13 Number of subjects
|
5 Number of subjects
|
4 Number of subjects
|
7 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Diarrhea - Vaccination 5 (N=47,48,24,23)
|
1 Number of subjects
|
4 Number of subjects
|
1 Number of subjects
|
1 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Diarrhea - Vaccination 6 (N=45,48,25,24)
|
7 Number of subjects
|
5 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Irritability - Vaccination 5 (N=47,48,24,23)
|
17 Number of subjects
|
30 Number of subjects
|
10 Number of subjects
|
13 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Fever (≥38 °C) - Vaccination 1 (N=48,50,25,23)
|
1 Number of subjects
|
9 Number of subjects
|
0 Number of subjects
|
1 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Analg. Antipyr. Med. Used-Vaccin 2 (N=48,49,25,24)
|
15 Number of subjects
|
23 Number of subjects
|
10 Number of subjects
|
8 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Analg. Antipyr. Med. Used-Vaccin 4 (N=48,48,25,24)
|
10 Number of subjects
|
17 Number of subjects
|
3 Number of subjects
|
9 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Analg. Antipyr. Med. Used-Vaccin 6 (N=45,48,25,24)
|
16 Number of subjects
|
33 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Unusual crying - Vaccination 3 (N=48,48,25,24)
|
11 Number of subjects
|
7 Number of subjects
|
9 Number of subjects
|
6 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Unusual crying - Vaccination 4 (N=48,48,25,24)
|
5 Number of subjects
|
3 Number of subjects
|
3 Number of subjects
|
2 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Change in eating habits- Vaccin 4 (N=48,48,25,24)
|
3 Number of subjects
|
3 Number of subjects
|
1 Number of subjects
|
1 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Change in eating habits- Vaccin 5 (N=47,48,24,23)
|
7 Number of subjects
|
14 Number of subjects
|
6 Number of subjects
|
6 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Irritability - Vaccination 6 (N=45,48,25,24)
|
20 Number of subjects
|
30 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Change in eating habits- Vaccin 6 (N=45,48,25,24)
|
11 Number of subjects
|
13 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Sleepiness - Vaccination 1
|
32 Number of subjects
|
32 Number of subjects
|
19 Number of subjects
|
15 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Sleepiness - Vaccination 2 (N=48,49,25,24)
|
19 Number of subjects
|
17 Number of subjects
|
12 Number of subjects
|
9 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Sleepiness - Vaccination 3 (N=48,48,25,24)
|
15 Number of subjects
|
21 Number of subjects
|
6 Number of subjects
|
7 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Sleepiness - Vaccination 4 (N=48,48,25,24)
|
5 Number of subjects
|
7 Number of subjects
|
6 Number of subjects
|
3 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Sleepiness - Vaccination 5 (N=47,48,24,23)
|
5 Number of subjects
|
20 Number of subjects
|
5 Number of subjects
|
10 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Sleepiness - Vaccination 6 (N=45,48,25,24)
|
4 Number of subjects
|
13 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Vomiting - Vaccination 1
|
9 Number of subjects
|
3 Number of subjects
|
7 Number of subjects
|
5 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Vomiting - Vaccination 2 (N=48,49,25,24)
|
4 Number of subjects
|
1 Number of subjects
|
5 Number of subjects
|
2 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Vomiting - Vaccination 3 (N=48,48,25,24)
|
3 Number of subjects
|
5 Number of subjects
|
1 Number of subjects
|
1 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Vomiting - Vaccination 4 (N=48,48,25,24)
|
3 Number of subjects
|
1 Number of subjects
|
1 Number of subjects
|
2 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Vomiting - Vaccination 5 (N=47,48,24,23)
|
6 Number of subjects
|
5 Number of subjects
|
1 Number of subjects
|
3 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Vomiting - Vaccination 6 (N=45,48,25,24)
|
4 Number of subjects
|
3 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Diarrhea - Vaccination 2 (N=48,49,25,24)
|
7 Number of subjects
|
5 Number of subjects
|
4 Number of subjects
|
3 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Diarrhea - Vaccination 3 (N=48,48,25,24)
|
8 Number of subjects
|
5 Number of subjects
|
3 Number of subjects
|
4 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Diarrhea - Vaccination 4 (N=48,48,25,24)
|
5 Number of subjects
|
2 Number of subjects
|
3 Number of subjects
|
3 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Irritability - Vaccination 1
|
34 Number of subjects
|
37 Number of subjects
|
17 Number of subjects
|
15 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Unusual crying - Vaccination 5 (N=47,48,24,23)
|
3 Number of subjects
|
10 Number of subjects
|
3 Number of subjects
|
4 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Unusual crying - Vaccination 6 (N=45,48,25,24)
|
3 Number of subjects
|
5 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Rash - Vaccination 1 (N=48,50,25,24)
|
10 Number of subjects
|
2 Number of subjects
|
2 Number of subjects
|
3 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Rash - Vaccination 2 (N=48,49,25,24)
|
6 Number of subjects
|
3 Number of subjects
|
3 Number of subjects
|
2 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Rash - Vaccination 3 (N=48,48,25,24)
|
7 Number of subjects
|
5 Number of subjects
|
0 Number of subjects
|
2 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Rash - Vaccination 4 (N=48,48,25,24)
|
9 Number of subjects
|
4 Number of subjects
|
3 Number of subjects
|
4 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Rash - Vaccination 5 (N=47,48,24,23)
|
7 Number of subjects
|
7 Number of subjects
|
5 Number of subjects
|
1 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Rash - Vaccination 6 (N=45,48,25,24)
|
6 Number of subjects
|
8 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Fever (≥38 °C) - Vaccination 2 (N=48,49,25,24)
|
0 Number of subjects
|
0 Number of subjects
|
1 Number of subjects
|
1 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Fever (≥38 °C) - Vaccination 3 (N=48,48,25,24)
|
3 Number of subjects
|
4 Number of subjects
|
2 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Fever (≥38 °C) - Vaccination 4 (N=48,48,25,24)
|
3 Number of subjects
|
0 Number of subjects
|
2 Number of subjects
|
1 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Fever (≥38 °C) - Vaccination 5 (N=47,48,24,23)
|
1 Number of subjects
|
2 Number of subjects
|
4 Number of subjects
|
4 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Fever (≥38 °C) - Vaccination 6 (N=45,48,25,24)
|
3 Number of subjects
|
3 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Analgesic/Antipyretic Med. Used-Vaccination 1
|
15 Number of subjects
|
29 Number of subjects
|
10 Number of subjects
|
8 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Analg. Antipyr. Med. Used-Vaccin 3 (N=48,48,25,24)
|
23 Number of subjects
|
31 Number of subjects
|
14 Number of subjects
|
10 Number of subjects
|
|
Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study
Analg. Antipyr. Med. Used-Vaccin 5 (N=47,48,24,23)
|
15 Number of subjects
|
30 Number of subjects
|
9 Number of subjects
|
13 Number of subjects
|
PRIMARY outcome
Timeframe: 30 days after the third vaccinationPopulation: Analysis was performed on the Per Protocol Set (PP) set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.
Percentage of subjects fourfold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99 and NZ98/254 were measured at one month after third-dose and calculated respect to baseline titers.
Outcome measures
| Measure |
rMenB
n=37 Participants
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=40 Participants
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Percentage of Subjects With Fourfold Rises in Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination or rMenB Vaccine With and Without OMV-NZ.
Str. 44/76-SL 4-fold Rise-Post-3rd dose (N=36,39)
|
69 Percentage of Subjects
Interval 52.0 to 84.0
|
85 Percentage of Subjects
Interval 69.0 to 94.0
|
—
|
—
|
|
Percentage of Subjects With Fourfold Rises in Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination or rMenB Vaccine With and Without OMV-NZ.
Str. 5/99-SL 4-fold Rise-Post-3rd dose (N=32,37)
|
97 Percentage of Subjects
Interval 84.0 to 100.0
|
92 Percentage of Subjects
Interval 78.0 to 98.0
|
—
|
—
|
|
Percentage of Subjects With Fourfold Rises in Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination or rMenB Vaccine With and Without OMV-NZ.
Str. NZ98/254-4-fold Rise-Post-3rd dose (N=37,40)
|
3 Percentage of Subjects
Interval 0.068 to 14.0
|
78 Percentage of Subjects
Interval 62.0 to 89.0
|
—
|
—
|
PRIMARY outcome
Timeframe: At baseline (pre-vaccination) and 30 days after the third vaccinationGeometric Mean Ratios (GMRs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the third immunization. The analysis was done on the Per Protocol population at one month after third injection.
Outcome measures
| Measure |
rMenB
n=37 Participants
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=40 Participants
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization.
Strain 5/99 (1 Month After 3rd Vacc;
|
131 Ratio
Interval 78.0 to 220.0
|
91 Ratio
Interval 53.0 to 158.0
|
—
|
—
|
|
Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization.
Strain 44/76-SL (1 Month After 3rd
|
9.89 Ratio
Interval 5.79 to 17.0
|
21 Ratio
Interval 13.0 to 34.0
|
—
|
—
|
|
Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization.
Strain NZ98/254 (1 Month After 3rd
|
0.91 Ratio
Interval 0.67 to 1.25
|
16 Ratio
Interval 9.2 to 28.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after first vaccinationPopulation: Analysis was performed on the PP set.
Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with fourfold rises in bactericidal titers for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) 1 month after first vaccination. The analysis was done on the Per Protocol population 1 month after first vaccination.
Outcome measures
| Measure |
rMenB
n=22 Participants
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=22 Participants
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination
44/76-SL (1 month after first Vacc; N=22, 22)
|
14 Percentage of subjects
Interval 3.0 to 35.0
|
36 Percentage of subjects
Interval 17.0 to 59.0
|
—
|
—
|
|
Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination
5/99 (1 month after first Vacc; N=21, 22)
|
100 Percentage of subjects
Interval 84.0 to 100.0
|
59 Percentage of subjects
Interval 36.0 to 79.0
|
—
|
—
|
|
Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination
NZ98/254 (1 month after first Vacc; N=21, 22)
|
0 Percentage of subjects
Interval 0.0 to 16.0
|
9 Percentage of subjects
Interval 1.0 to 29.0
|
—
|
—
|
|
Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination
44/76-SL (1 month after 4th (booster); N=37, 30)
|
92 Percentage of subjects
Interval 78.0 to 98.0
|
93 Percentage of subjects
Interval 78.0 to 99.0
|
—
|
—
|
|
Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination
5/99 (1 month after 4th (booster); N=33, 27)
|
97 Percentage of subjects
Interval 85.0 to 100.0
|
97 Percentage of subjects
Interval 83.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination
NZ98/254 (1 month after 4th (booster); N=38, 29)
|
0 Percentage of subjects
Interval 0.0 to 9.0
|
76 Percentage of subjects
Interval 56.0 to 90.0
|
—
|
—
|
SECONDARY outcome
Timeframe: prior 1st dose, 30 days post-2nd vaccination, 12 months age to 1 month post 4th vaccinationPopulation: Analysis was performed on the PP set.
Geometric mean bactericidal titers as measure of the Bactericidal activity against meningococcal strains 44/76-SL, 5/99 and NZ98/254, before vaccination (baseline) and at 30 days after second immunization, at 12 months age,and 30 days after the fourth (booster) vaccination.
Outcome measures
| Measure |
rMenB
n=46 Participants
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=46 Participants
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age
Strain 44/76-SL (pre-vaccination; N=45, 45)
|
1.32 titers
Interval 1.05 to 1.66
|
1.4 titers
Interval 1.16 to 1.69
|
—
|
—
|
|
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age
Strain 5/99 (pre-vaccination; N=42, 43)
|
1.22 titers
Interval 0.98 to 1.52
|
1.43 titers
Interval 1.12 to 1.81
|
—
|
—
|
|
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age
Strain NZ98/254 (pre-vaccination; N=46, 46)
|
1.23 titers
Interval 1.0 to 1.52
|
1.15 titers
Interval 1.02 to 1.29
|
—
|
—
|
|
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age
Strain 44/76-SL (1 Month After 2nd Vacc; N=40, 37)
|
5.96 titers
Interval 3.94 to 9.01
|
28 titers
Interval 19.0 to 40.0
|
—
|
—
|
|
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age
Strain 5/99 (1 Month After 2nd Vacc; N=36, 33)
|
119 titers
Interval 63.0 to 223.0
|
104 titers
Interval 64.0 to 169.0
|
—
|
—
|
|
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age
Strain NZ98/254 (1 Month After 2nd Vacc; N=41, 38)
|
1.13 titers
Interval 0.97 to 1.31
|
6.55 titers
Interval 4.77 to 8.99
|
—
|
—
|
|
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age
44/76-SL (6 months after pre-booster; N=40, 44)
|
5.46 titers
Interval 4.06 to 7.35
|
5.07 titers
Interval 3.62 to 7.1
|
—
|
—
|
|
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age
5/99 (6 months after pre-booster; N=37, 40)
|
37 titers
Interval 23.0 to 61.0
|
21 titers
Interval 13.0 to 37.0
|
—
|
—
|
|
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age
NZ98/254 (6 months after pre-booster; N=41, 44)
|
1.14 titers
Interval 0.95 to 1.38
|
2.38 titers
Interval 1.65 to 3.43
|
—
|
—
|
|
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age
44/76-SL (1 month after booster; N=38, 31)
|
56 titers
Interval 40.0 to 79.0
|
114 titers
Interval 76.0 to 173.0
|
—
|
—
|
|
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age
5/99 (1 month after booster; N=34, 30)
|
261 titers
Interval 157.0 to 435.0
|
691 titers
Interval 357.0 to 1340.0
|
—
|
—
|
|
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age
NZ98/254 (1 month after booster; N=39, 31)
|
1.09 titers
Interval 0.91 to 1.31
|
33 titers
Interval 17.0 to 61.0
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-first vaccination and 1 month after first vaccinationPopulation: Analysis was performed on the PP set.
Geometric Mean Titers (GMTs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Routine +Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) at 12 months age, i.e. pre-first vaccination and 1 month after first vaccination. The analysis was done on the Per Protocol population.
Outcome measures
| Measure |
rMenB
n=22 Participants
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=22 Participants
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ
44/76-SL (1 month after first Vacc; N=22,22)
|
2.34 titers
Interval 1.66 to 3.29
|
6.02 titers
Interval 3.5 to 10.0
|
—
|
—
|
|
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ
5/99 (1 month after first Vacc; N=21,22)
|
73 titers
Interval 53.0 to 101.0
|
8 titers
Interval 4.2 to 15.0
|
—
|
—
|
|
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ
NZ98/254 (1 month after first Vacc; N=21, 22)
|
1 titers
Interval 1.0 to 1.0
|
1.66 titers
Interval 1.12 to 2.45
|
—
|
—
|
|
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ
44/76-SL (pre-vaccination; N=22,22)
|
1.55 titers
Interval 1.22 to 1.98
|
1.88 titers
Interval 1.19 to 2.96
|
—
|
—
|
|
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ
5/99 (pre-vaccination; N=21,22)
|
1 titers
Interval 1.0 to 1.0
|
1 titers
Interval 1.0 to 1.0
|
—
|
—
|
|
Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ
NZ98/254 (pre-vaccination; N=21, 22)
|
1.03 titers
Interval 0.96 to 1.11
|
1 titers
Interval 1.0 to 1.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the second vaccination and 1 month after fourth (booster) vaccinationPopulation: Analysis was performed on the PP set.
Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the second immunization and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population at 30 days after the second immunization and 1 month after fourth (booster) vaccination.of age.
Outcome measures
| Measure |
rMenB
n=41 Participants
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=38 Participants
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination
Strain 5/99 (1 Month After 2nd Vacc; N=36, 33)
|
104 ratios
Interval 54.0 to 200.0
|
71 ratios
Interval 44.0 to 115.0
|
—
|
—
|
|
Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination
Strain NZ98/254 (1 Month After 2nd Vacc; N=41, 38)
|
0.92 ratios
Interval 0.69 to 1.22
|
5.55 ratios
Interval 3.9 to 7.92
|
—
|
—
|
|
Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination
44/76-SL (1 month after booster; N=38, 31)
|
42 ratios
Interval 28.0 to 64.0
|
78 ratios
Interval 47.0 to 130.0
|
—
|
—
|
|
Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination
5/99 (1 month after booster; N=34, 30)
|
217 ratios
Interval 128.0 to 370.0
|
467 ratios
Interval 231.0 to 945.0
|
—
|
—
|
|
Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination
NZ98/254 (1 month after booster; N=39, 31)
|
0.85 ratios
Interval 0.62 to 1.16
|
28 ratios
Interval 15.0 to 52.0
|
—
|
—
|
|
Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination
Strain 44/76-SL (1 Month After 2nd Vacc; N=40, 37)
|
4.36 ratios
Interval 2.78 to 6.84
|
19 ratios
Interval 13.0 to 29.0
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-first vaccination and 1 month after first vaccinationPopulation: Analysis was performed on the PP set after booster vaccination.
Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with a bactericidal activity (BCA) measured as BCA titer ≥1:4 for the for three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination. The analysis was done on the Per Protocol population at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination.
Outcome measures
| Measure |
rMenB
n=22 Participants
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=22 Participants
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age
44/76-SL (12 Months Age, pre-first vacc; N=22,22)
|
9 Percentage of subjects
Interval 1.0 to 29.0
|
18 Percentage of subjects
Interval 5.0 to 40.0
|
—
|
—
|
|
Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age
5/99 (12 Months of Age, pre-first vacc; N=21,22)
|
0 Percentage of subjects
Interval 0.0 to 16.0
|
0 Percentage of subjects
Interval 0.0 to 15.0
|
—
|
—
|
|
Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age
NZ98/254 (12 Months Age, pre-first vacc; N=21,22)
|
0 Percentage of subjects
Interval 0.0 to 16.0
|
0 Percentage of subjects
Interval 0.0 to 15.0
|
—
|
—
|
|
Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age
44/76-SL (1 month after first Vacc; N=22,22)
|
32 Percentage of subjects
Interval 14.0 to 55.0
|
73 Percentage of subjects
Interval 50.0 to 89.0
|
—
|
—
|
|
Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age
5/99 (1 month after first Vacc; N=21,22)
|
100 Percentage of subjects
Interval 84.0 to 100.0
|
73 Percentage of subjects
Interval 50.0 to 89.0
|
—
|
—
|
|
Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age
NZ98/254 (1 month after first Vacc; N=21, 22)
|
0 Percentage of subjects
Interval 0.0 to 16.0
|
18 Percentage of subjects
Interval 5.0 to 40.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after first vaccinationGeometric Mean Ratios to baseline against a panel of genetically distinct meningococcal strains 30 days after a single dose administered at 12 months of age.
Outcome measures
| Measure |
rMenB
n=22 Participants
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=22 Participants
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After a Single Dose Administered at 12 Months of Age
44/76-SL (1 month after first Vacc; N=22, 22)
|
1.51 Ratio
Interval 1.02 to 2.22
|
3.21 Ratio
Interval 1.9 to 5.41
|
—
|
—
|
|
Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After a Single Dose Administered at 12 Months of Age
5/99 (1 month after first Vacc; N=21, 22)
|
73 Ratio
Interval 53.0 to 101.0
|
8 Ratio
Interval 4.2 to 15.0
|
—
|
—
|
|
Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After a Single Dose Administered at 12 Months of Age
NZ98/254 (1 month after first Vacc; N=21, 22)
|
0.97 Ratio
Interval 0.9 to 1.04
|
1.66 Ratio
Interval 1.12 to 2.45
|
—
|
—
|
SECONDARY outcome
Timeframe: At pre-vaccination and 30 days post the 2nd vaccination and at 12 months age, and 1 month post 4th (booster) vaccination.Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with fourfold rises in bactericidal titers for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, i.e. 6 months after third (pre-booster) vaccination, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population 30 days after the second vaccination and at 12 months age.
Outcome measures
| Measure |
rMenB
n=41 Participants
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=44 Participants
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age
Strain 44/76-SL (1 Month After 2nd Vacc; N=40, 37)
|
50 Percentages of Subjects
Interval 34.0 to 66.0
|
86 Percentages of Subjects
Interval 71.0 to 95.0
|
—
|
—
|
|
Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age
Strain 5/99 (1 Month After 2nd Vacc; N=36, 33)
|
89 Percentages of Subjects
Interval 74.0 to 97.0
|
94 Percentages of Subjects
Interval 80.0 to 99.0
|
—
|
—
|
|
Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age
Strain NZ98/254 (1 Month After 2nd Vacc N=41, 38)
|
2 Percentages of Subjects
Interval 0.062 to 13.0
|
55 Percentages of Subjects
Interval 38.0 to 71.0
|
—
|
—
|
|
Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age
44/76-SL (6 months after pre-booster; N=40, 44)
|
45 Percentages of Subjects
Interval 29.0 to 62.0
|
41 Percentages of Subjects
Interval 26.0 to 57.0
|
—
|
—
|
|
Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age
5/99 (6 months after pre-booster; N=37, 40)
|
84 Percentages of Subjects
Interval 68.0 to 94.0
|
65 Percentages of Subjects
Interval 48.0 to 79.0
|
—
|
—
|
|
Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age
NZ98/254 (6 months after pre-booster; N=41, 44)
|
2 Percentages of Subjects
Interval 0.062 to 13.0
|
23 Percentages of Subjects
Interval 11.0 to 38.0
|
—
|
—
|
|
Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age
44/76-SL (1 month after 4th (booster); N=37, 30)
|
92 Percentages of Subjects
Interval 78.0 to 98.0
|
93 Percentages of Subjects
Interval 78.0 to 99.0
|
—
|
—
|
|
Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age
5/99 (1 month after 4th (booster); N=33, 27)
|
95 Percentages of Subjects
Interval 85.0 to 100.0
|
97 Percentages of Subjects
Interval 83.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age
NZ98/254 (1 month after 4th (booster); N=38, 29)
|
0 Percentages of Subjects
Interval 0.0 to 9.0
|
76 Percentages of Subjects
Interval 56.0 to 90.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline (pre-vaccination) and 30 days after the second vaccination and at 12 months age.Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with a BCA titer ≥1:4 for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population.
Outcome measures
| Measure |
rMenB
n=46 Participants
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=46 Participants
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age
Strain 44/76-SL (Pre-Vaccination; N=45, 45)
|
11 Percentages of Subjects
Interval 4.0 to 24.0
|
11 Percentages of Subjects
Interval 4.0 to 24.0
|
—
|
—
|
|
Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age
Strain 5/99 (Pre-vaccination; N=42, 43)
|
7 Percentages of Subjects
Interval 1.0 to 19.0
|
14 Percentages of Subjects
Interval 5.0 to 28.0
|
—
|
—
|
|
Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age
Strain NZ98/254 Pre-Vaccination; N=46, 46)
|
4 Percentages of Subjects
Interval 1.0 to 15.0
|
9 Percentages of Subjects
Interval 2.0 to 11.0
|
—
|
—
|
|
Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age
Strain 44/76-SL (1 Month After 2nd Vacc; N=40, 37)
|
58 Percentages of Subjects
Interval 41.0 to 73.0
|
95 Percentages of Subjects
Interval 82.0 to 99.0
|
—
|
—
|
|
Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age
Strain 5/99 (1 Month After 2nd Vacc; N=36, 33)
|
89 Percentages of Subjects
Interval 74.0 to 97.0
|
100 Percentages of Subjects
Interval 89.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age
Strain NZ98/254 (1 Month After 2nd Vacc; N=41, 38
|
5 Percentages of Subjects
Interval 1.0 to 17.0
|
74 Percentages of Subjects
Interval 57.0 to 87.0
|
—
|
—
|
|
Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age
44/76-SL (6 months after pre-booster; N=40, 44)
|
70 Percentages of Subjects
Interval 53.0 to 83.0
|
68 Percentages of Subjects
Interval 52.0 to 81.0
|
—
|
—
|
|
Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age
Strain 5/99 (6 months after prebooster; N=37, 40)
|
92 Percentages of Subjects
Interval 78.0 to 98.0
|
88 Percentages of Subjects
Interval 73.0 to 96.0
|
—
|
—
|
|
Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age
NZ98/254 (6 months after pre-booster; N=41, 44)
|
5 Percentages of Subjects
Interval 1.0 to 17.0
|
36 Percentages of Subjects
Interval 22.0 to 52.0
|
—
|
—
|
|
Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age
44/76-SL (1 month after booster; N=38, 31)
|
100 Percentages of Subjects
Interval 91.0 to 100.0
|
100 Percentages of Subjects
Interval 89.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age
5/99 (1 month after booster; N=34, 30)
|
97 Percentages of Subjects
Interval 85.0 to 100.0
|
97 Percentages of Subjects
Interval 83.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age
NZ98/254 (1 month after booster; N=39, 31)
|
3 Percentages of Subjects
Interval 0.065 to 13.0
|
94 Percentages of Subjects
Interval 79.0 to 99.0
|
—
|
—
|
Adverse Events
rMenB
Serious events: 3 serious events
Other events: 48 other events
Deaths: 0 deaths
rMenB+OMV
Serious events: 9 serious events
Other events: 50 other events
Deaths: 0 deaths
Routine
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Routine+OMV
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rMenB
n=48 participants at risk
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=50 participants at risk
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
n=25 participants at risk
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
n=24 participants at risk
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/48 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/50 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/24 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/48 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/25 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/24 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
General disorders
Pyrexia
|
0.00%
0/48 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/25 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/24 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Bronchiolitis
|
4.2%
2/48 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.0%
1/25 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/24 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/48 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/25 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/24 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/48 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/50 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/24 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/48 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/25 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/24 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/48 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/50 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/24 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/48 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/25 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/24 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/48 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/25 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/24 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Viral infection
|
0.00%
0/48 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/50 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/25 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
2.1%
1/48 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/50 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/25 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/24 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/48 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/25 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/24 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/48 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/50 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/25 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
Other adverse events
| Measure |
rMenB
n=48 participants at risk
Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
rMenB+OMV
n=50 participants at risk
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
|
Routine
n=25 participants at risk
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age.
|
Routine+OMV
n=24 participants at risk
Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).
Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age.
|
|---|---|---|---|---|
|
Investigations
Body temperature increased
|
0.00%
0/48 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
8.0%
2/25 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.1%
13/48 • Number of events 15 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
20.0%
10/50 • Number of events 13 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
16.0%
4/25 • Number of events 4 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
20.8%
5/24 • Number of events 7 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
0.00%
0/48 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
10.0%
5/50 • Number of events 7 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.0%
1/25 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Nervous system disorders
Somnolence
|
77.1%
37/48 • Number of events 97 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
80.0%
40/50 • Number of events 127 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
88.0%
22/25 • Number of events 52 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
83.3%
20/24 • Number of events 48 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
General disorders
Crying
|
54.2%
26/48 • Number of events 51 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
48.0%
24/50 • Number of events 49 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
60.0%
15/25 • Number of events 33 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
50.0%
12/24 • Number of events 21 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
General disorders
Injection Site Bruising
|
8.3%
4/48 • Number of events 4 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
8.0%
4/50 • Number of events 5 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/25 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/24 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
General disorders
Injection Site Erythema
|
97.9%
47/48 • Number of events 499 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
98.0%
49/50 • Number of events 532 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
100.0%
25/25 • Number of events 211 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
100.0%
24/24 • Number of events 199 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
General disorders
Injection site induration
|
85.4%
41/48 • Number of events 218 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
90.0%
45/50 • Number of events 50 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
88.0%
22/25 • Number of events 99 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
100.0%
24/24 • Number of events 130 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
General disorders
Injection Site pain
|
75.0%
36/48 • Number of events 145 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
74.0%
37/50 • Number of events 181 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
52.0%
13/25 • Number of events 50 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
75.0%
18/24 • Number of events 64 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
General disorders
Pyrexia
|
22.9%
11/48 • Number of events 15 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
30.0%
15/50 • Number of events 20 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
24.0%
6/25 • Number of events 12 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
25.0%
6/24 • Number of events 8 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
General disorders
Vaccination Site Erythema
|
6.2%
3/48 • Number of events 5 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
8.0%
4/50 • Number of events 7 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
8.0%
2/25 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
8.3%
2/24 • Number of events 3 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Psychiatric disorders
Irritability
|
87.5%
42/48 • Number of events 170 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
96.0%
48/50 • Number of events 222 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
92.0%
23/25 • Number of events 84 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
100.0%
24/24 • Number of events 81 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Psychiatric disorders
Eating disorder
|
56.2%
27/48 • Number of events 52 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
64.0%
32/50 • Number of events 72 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
60.0%
15/25 • Number of events 35 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
50.0%
12/24 • Number of events 20 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
54.2%
26/48 • Number of events 53 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
44.0%
22/50 • Number of events 32 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
52.0%
13/25 • Number of events 24 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
50.0%
12/24 • Number of events 29 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
2.1%
1/48 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/25 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
8.3%
2/24 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Gastrointestinal disorders
Teething
|
22.9%
11/48 • Number of events 17 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
30.0%
15/50 • Number of events 20 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
12.0%
3/25 • Number of events 3 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
20.8%
5/24 • Number of events 6 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
45.8%
22/48 • Number of events 36 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
32.0%
16/50 • Number of events 24 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
48.0%
12/25 • Number of events 23 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
50.0%
12/24 • Number of events 17 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
16.7%
8/48 • Number of events 9 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
12.0%
6/50 • Number of events 6 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
8.0%
2/25 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
16.7%
4/24 • Number of events 6 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash
|
41.7%
20/48 • Number of events 60 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
38.0%
19/50 • Number of events 36 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
40.0%
10/25 • Number of events 17 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
29.2%
7/24 • Number of events 14 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Bronchiolitis
|
14.6%
7/48 • Number of events 9 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.0%
2/50 • Number of events 3 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.0%
1/25 • Number of events 3 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/24 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Conjunctivitis
|
16.7%
8/48 • Number of events 13 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
10.0%
5/50 • Number of events 5 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
12.5%
3/24 • Number of events 3 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Gastroenteritis
|
6.2%
3/48 • Number of events 3 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
8.0%
4/50 • Number of events 4 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
8.0%
2/25 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/24 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/48 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
2.0%
1/50 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/25 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
8.3%
2/24 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Gastroenteritis Viral
|
6.2%
3/48 • Number of events 3 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/25 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
8.3%
2/24 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Otitis Media
|
12.5%
6/48 • Number of events 6 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
14.0%
7/50 • Number of events 7 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
12.0%
3/25 • Number of events 4 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
10.4%
5/48 • Number of events 5 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
24.0%
12/50 • Number of events 16 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
8.0%
2/25 • Number of events 5 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
20.8%
5/24 • Number of events 6 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
20.8%
10/48 • Number of events 10 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
24.0%
12/50 • Number of events 13 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
12.0%
3/25 • Number of events 4 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
8.3%
2/24 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Rhinitis
|
39.6%
19/48 • Number of events 29 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
38.0%
19/50 • Number of events 25 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
16.0%
4/25 • Number of events 5 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
29.2%
7/24 • Number of events 9 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Varicella
|
2.1%
1/48 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
6.0%
3/50 • Number of events 3 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/25 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Viral Infection
|
2.1%
1/48 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.0%
2/50 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.0%
1/25 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
12.5%
3/24 • Number of events 4 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Viral Rash
|
0.00%
0/48 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
6.0%
3/50 • Number of events 3 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
8.0%
2/25 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
4.2%
1/24 • Number of events 1 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
4.2%
2/48 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
2.0%
1/50 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
12.0%
3/25 • Number of events 3 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
0.00%
0/24 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
|
General disorders
Vaccination Site Induration
|
10.4%
5/48 • Number of events 9 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
12.0%
6/50 • Number of events 8 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
8.0%
2/25 • Number of events 2 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
12.5%
3/24 • Number of events 3 • Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
\>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60