Trial Outcomes & Findings for Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules (NCT NCT00721396)
NCT ID: NCT00721396
Last Updated: 2015-03-23
Results Overview
The percentage of subjects with serum bactericidal activity(hSBA)titer ≥1:5 after receiving three doses of rMenB+OMV NZ vaccine were evaluated to demonstrate sufficient immune response following rMenB+OMV NZ vaccination, when given concomitantly with routine infant vaccines to healthy infants. The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA). The immune response was considered sufficient for groups B+R246 and B+R234 if the lower limit of the 2-sided 95% confidence interval was ≥ 70% for all three strains.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1885 participants
Primary outcome timeframe
One month after third Men B vaccination
Results posted on
2015-03-23
Participant Flow
Subjects were recruited from 4 centers in UK, 5 centers in Italy, 16 centers in Spain, 6 centers in Belgium, 25 centers in Germany and 4 centers in Czech Republic
All subjects enrolled were included in the trial.
Participant milestones
| Measure |
B+R246
Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
|
B246_R357
Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
|
B+R234
Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
|
R234
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
627
|
628
|
318
|
312
|
|
Overall Study
COMPLETED
|
597
|
592
|
308
|
302
|
|
Overall Study
NOT COMPLETED
|
30
|
36
|
10
|
10
|
Reasons for withdrawal
| Measure |
B+R246
Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
|
B246_R357
Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
|
B+R234
Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
|
R234
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
7
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
12
|
15
|
3
|
7
|
|
Overall Study
Lost to Follow-up
|
7
|
9
|
3
|
3
|
|
Overall Study
Protocol Violation
|
4
|
3
|
1
|
0
|
|
Overall Study
Inappropriate enrollment
|
0
|
2
|
0
|
0
|
|
Overall Study
Administrative reason
|
3
|
0
|
1
|
0
|
Baseline Characteristics
Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules
Baseline characteristics by cohort
| Measure |
B+R246
n=627 Participants
Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
|
B246_R357
n=628 Participants
Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
|
B+R234
n=318 Participants
Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
|
R234
n=312 Participants
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
|
Total
n=1885 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
68.7 days
STANDARD_DEVIATION 8.9 • n=5 Participants
|
68.8 days
STANDARD_DEVIATION 9.4 • n=7 Participants
|
68.8 days
STANDARD_DEVIATION 9.1 • n=5 Participants
|
68.1 days
STANDARD_DEVIATION 9.0 • n=4 Participants
|
68.7 days
STANDARD_DEVIATION 9.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
292 Participants
n=5 Participants
|
312 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
927 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
335 Participants
n=5 Participants
|
316 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
958 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: One month after third Men B vaccinationPopulation: The analysis was done on the Modified Intention to Treat (MIIT) population, ie, enrolled subjects who actually received a study vaccination and provided at least one evaluable serum sample after baseline.
The percentage of subjects with serum bactericidal activity(hSBA)titer ≥1:5 after receiving three doses of rMenB+OMV NZ vaccine were evaluated to demonstrate sufficient immune response following rMenB+OMV NZ vaccination, when given concomitantly with routine infant vaccines to healthy infants. The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA). The immune response was considered sufficient for groups B+R246 and B+R234 if the lower limit of the 2-sided 95% confidence interval was ≥ 70% for all three strains.
Outcome measures
| Measure |
B+R246
n=587 Participants
Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
|
B246_R357
n=589 Participants
Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
|
B+R234
n=300 Participants
Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
|
R234
n=292 Participants
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
|
|---|---|---|---|---|
|
Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine
Baseline (44/76-SL strain)N=587,589,300,291
|
9 Percentages of subjects
Interval 6.0 to 11.0
|
7 Percentages of subjects
Interval 5.0 to 9.0
|
6 Percentages of subjects
Interval 4.0 to 10.0
|
6 Percentages of subjects
Interval 4.0 to 10.0
|
|
Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine
Post vaccination (44/76-SL)N=550,561,283,265
|
99 Percentages of subjects
Interval 98.0 to 100.0
|
99 Percentages of subjects
Interval 98.0 to 100.0
|
99 Percentages of subjects
Interval 97.0 to 100.0
|
4 Percentages of subjects
Interval 2.0 to 7.0
|
|
Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine
Baseline (5/99 strain)N=580,577,294,289
|
5 Percentages of subjects
Interval 4.0 to 8.0
|
7 Percentages of subjects
Interval 5.0 to 9.0
|
5 Percentages of subjects
Interval 3.0 to 8.0
|
6 Percentages of subjects
Interval 3.0 to 9.0
|
|
Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine
Post vaccination (5/99 strain)N=551,554,285,245
|
99 Percentages of subjects
Interval 98.0 to 100.0
|
99 Percentages of subjects
Interval 98.0 to 100.0
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
5 Percentages of subjects
Interval 3.0 to 8.0
|
|
Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine
Baseline(NZ98/254 strain)N=582,583,298,292
|
3 Percentages of subjects
Interval 2.0 to 5.0
|
1 Percentages of subjects
Interval 0.0 to 2.0
|
2 Percentages of subjects
Interval 1.0 to 4.0
|
1 Percentages of subjects
Interval 0.083 to 2.0
|
|
Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine
Post vaccination(NZ98/254 strain)N=555,559,284,269
|
79 Percentages of subjects
Interval 75.0 to 82.0
|
87 Percentages of subjects
Interval 84.0 to 89.0
|
81 Percentages of subjects
Interval 76.0 to 85.0
|
4 Percentages of subjects
Interval 2.0 to 8.0
|
PRIMARY outcome
Timeframe: 10 months (groups 1 and 2); 8 months (groups 3 and 4)Population: All subjects receiving at least one injection and providing post-baseline safety data (Safety Set).
Safety and Tolerability of 3 Doses of rMenB was assessed in terms of the number of subjects who reported solicited local and systemic adverse events when administered concomitantly with routine infant vaccines at 2,4,6 months of age (B+R246) to when rMenB+OMV NZ and routine vaccines were administered separately (group B246\_R357).
Outcome measures
| Measure |
B+R246
n=624 Participants
Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
|
B246_R357
n=627 Participants
Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
|
B+R234
n=318 Participants
Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
|
R234
n=311 Participants
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
|
|---|---|---|---|---|
|
Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age
Tenderness (N=624,626,318,311)
|
529 Number of subjects
|
491 Number of subjects
|
265 Number of subjects
|
0 Number of subjects
|
|
Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age
Erythema (N=624,626,318,311)
|
506 Number of subjects
|
516 Number of subjects
|
257 Number of subjects
|
0 Number of subjects
|
|
Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age
Induration (N=624,626,318,311)
|
447 Number of subjects
|
465 Number of subjects
|
230 Number of subjects
|
0 Number of subjects
|
|
Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age
Swelling (N=624,626,318,311)
|
290 Number of subjects
|
324 Number of subjects
|
149 Number of subjects
|
0 Number of subjects
|
|
Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age
Change in Eating Habits (N=624,626,318,311)
|
470 Number of subjects
|
473 Number of subjects
|
249 Number of subjects
|
159 Number of subjects
|
|
Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age
Sleepiness (N=624,626,318,311)
|
523 Number of subjects
|
525 Number of subjects
|
282 Number of subjects
|
224 Number of subjects
|
|
Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age
Vomiting (N=624,626,318,311)
|
193 Number of subjects
|
234 Number of subjects
|
97 Number of subjects
|
83 Number of subjects
|
|
Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age
Diarrhea (N=624,626,318,311)
|
284 Number of subjects
|
327 Number of subjects
|
138 Number of subjects
|
113 Number of subjects
|
|
Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age
Irritability (N=624,626,318,311)
|
543 Number of subjects
|
527 Number of subjects
|
289 Number of subjects
|
220 Number of subjects
|
|
Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age
Unusual Crying (N=624,626,318,311)
|
526 Number of subjects
|
515 Number of subjects
|
268 Number of subjects
|
186 Number of subjects
|
|
Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age
Rash (N=624,626,318,311)
|
84 Number of subjects
|
130 Number of subjects
|
42 Number of subjects
|
39 Number of subjects
|
|
Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age
Fever (≥38.0 C° %) ((N=624,627,318,311)
|
501 Number of subjects
|
447 Number of subjects
|
243 Number of subjects
|
160 Number of subjects
|
SECONDARY outcome
Timeframe: One month after 3rd Men B vaccinationPopulation: Analysis was done on the per-protocol population i.e all subjects in the MITT 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.
The non-inferiority of immune response to rMenB+OMV NZ vaccination when administered concomitantly with routine infant vaccines at 2,4,6 months of age(B+R246) to when rMenB+OMV NZ and routine vaccines were administered separately (group B246\_R357)was assessed in terms of percentage of subjects With hSBA≥ 1:5.
Outcome measures
| Measure |
B+R246
n=556 Participants
Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
|
B246_R357
n=548 Participants
Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
|
B+R234
Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
|
R234
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
|
|---|---|---|---|---|
|
Non-inferiority of Immune Response to rMenB+OMV NZ Vaccination When Administered Concomitantly With Routine Infant Vaccines at 2,4,6 Months of Age
Baseline(44/76-SL strain)
|
8 Percentages of subjects
Interval 6.0 to 11.0
|
7 Percentages of subjects
Interval 5.0 to 9.0
|
—
|
—
|
|
Non-inferiority of Immune Response to rMenB+OMV NZ Vaccination When Administered Concomitantly With Routine Infant Vaccines at 2,4,6 Months of Age
1 month post 3rd vaccination(44/76-SL)N=525,534
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
—
|
—
|
|
Non-inferiority of Immune Response to rMenB+OMV NZ Vaccination When Administered Concomitantly With Routine Infant Vaccines at 2,4,6 Months of Age
Baseline(5/99 strain)N=511,537
|
6 Percentages of subjects
Interval 4.0 to 8.0
|
7 Percentages of subjects
Interval 5.0 to 9.0
|
—
|
—
|
|
Non-inferiority of Immune Response to rMenB+OMV NZ Vaccination When Administered Concomitantly With Routine Infant Vaccines at 2,4,6 Months of Age
1 month post 3rd vaccination(5/99strain)N=527,529
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
99 Percentages of subjects
Interval 98.0 to 100.0
|
—
|
—
|
|
Non-inferiority of Immune Response to rMenB+OMV NZ Vaccination When Administered Concomitantly With Routine Infant Vaccines at 2,4,6 Months of Age
Baseline(NZ98/254 strain)N=554,543
|
3 Percentages of subjects
Interval 2.0 to 5.0
|
1 Percentages of subjects
Interval 0.0 to 2.0
|
—
|
—
|
|
Non-inferiority of Immune Response to rMenB+OMV NZ Vaccination When Administered Concomitantly With Routine Infant Vaccines at 2,4,6 Months of Age
1 month post 3rd vaccination(NZ98/254 )N=530,534
|
79 Percentages of subjects
Interval 76.0 to 83.0
|
87 Percentages of subjects
Interval 84.0 to 90.0
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after 3rd vaccinationPopulation: All subjects in the Full Analysis Set/MITT population who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis: Per Protocol (PP) Population.
Non-inferiority of immune response to routine vaccine antigens when routine vaccines were administered concomitantly with rMenB+OMV NZ vaccine \[group B+R234\] to when only routine vaccines were given \[Group R234\] were assessed in terms of percentage of subjects with antibody concentrations ≥0.1 IU/mL against Diphtheria and Tetanus antigens as measured by enzyme-linked immunosorbent assay.
Outcome measures
| Measure |
B+R246
n=269 Participants
Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
|
B246_R357
n=259 Participants
Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
|
B+R234
Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
|
R234
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
|
|---|---|---|---|---|
|
Non-inferiority of Immune Response to Diphtheria and Tetanus Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine
Baseline (Diphtheria)
|
25 Percentages of subjects
Interval 20.0 to 30.0
|
21 Percentages of subjects
Interval 16.0 to 26.0
|
—
|
—
|
|
Non-inferiority of Immune Response to Diphtheria and Tetanus Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine
1 month after 3rd vaccination(Diphtheria)N=261,232
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
100 Percentages of subjects
Interval 98.0 to 100.0
|
—
|
—
|
|
Non-inferiority of Immune Response to Diphtheria and Tetanus Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine
Baseline (Tetanus)
|
81 Percentages of subjects
Interval 76.0 to 86.0
|
86 Percentages of subjects
Interval 81.0 to 90.0
|
—
|
—
|
|
Non-inferiority of Immune Response to Diphtheria and Tetanus Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine
1 month after 3rd vaccination (Tetanus)N=261,232
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
100 Percentages of subjects
Interval 98.0 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after third Men B vaccinationPopulation: PP Population
The hSBA antibody titers when rMenB+OMV NZ vaccine is administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately are reported in terms of vaccine-group-specific geometric mean titers.
Outcome measures
| Measure |
B+R246
n=556 Participants
Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
|
B246_R357
n=548 Participants
Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
|
B+R234
n=285 Participants
Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
|
R234
n=277 Participants
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
|
|---|---|---|---|---|
|
Geometric Mean Titers Against Neisseria Meningitidis Serogroup B, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
Baseline (44/76-SL strain) N=556,548,285,277
|
1.49 Titers
Interval 1.4 to 1.59
|
1.36 Titers
Interval 1.28 to 1.46
|
1.34 Titers
Interval 1.23 to 1.46
|
1.28 Titers
Interval 1.19 to 1.37
|
|
Geometric Mean Titers Against Neisseria Meningitidis Serogroup B, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
post vaccination (44/76-SL) N=525,534,273,253
|
86 Titers
Interval 80.0 to 92.0
|
113 Titers
Interval 105.0 to 121.0
|
82 Titers
Interval 75.0 to 91.0
|
1.16 Titers
Interval 1.09 to 1.24
|
|
Geometric Mean Titers Against Neisseria Meningitidis Serogroup B, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
Baseline (5/99 strain) N=551,537,280,275
|
1.3 Titers
Interval 1.21 to 1.39
|
1.28 Titers
Interval 1.2 to 1.37
|
1.19 Titers
Interval 1.09 to 1.3
|
1.24 Titers
Interval 1.15 to 1.33
|
|
Geometric Mean Titers Against Neisseria Meningitidis Serogroup B, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
post vaccination (5/99 strain)N=527,529,275,236
|
537 Titers
Interval 494.0 to 584.0
|
699 Titers
Interval 643.0 to 759.0
|
325 Titers
Interval 292.0 to 362.0
|
1.25 Titers
Interval 1.08 to 1.45
|
|
Geometric Mean Titers Against Neisseria Meningitidis Serogroup B, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
Baseline (NZ98/254 strain)N=554,543,283,278
|
1.13 Titers
Interval 1.08 to 1.18
|
1.08 Titers
Interval 1.04 to 1.13
|
1.06 Titers
Interval 1.0 to 1.12
|
1.07 Titers
Interval 1.03 to 1.1
|
|
Geometric Mean Titers Against Neisseria Meningitidis Serogroup B, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
post vaccination (NZ98/254 strain)N=30,534,274,257
|
12 Titers
Interval 11.0 to 14.0
|
18 Titers
Interval 16.0 to 20.0
|
11 Titers
Interval 9.14 to 12.0
|
1.11 Titers
Interval 1.04 to 1.19
|
SECONDARY outcome
Timeframe: one month after third Men B vaccinationPopulation: PP Population
The geometric mean ratio(GMR) of GMTs at 1 month after 3rd rMenB+OMV NZ vaccination to prevaccination GMTs, when rMenB+OMV NZ was administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately.
Outcome measures
| Measure |
B+R246
n=504 Participants
Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
|
B246_R357
n=507 Participants
Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
|
B+R234
n=262 Participants
Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
|
R234
n=238 Participants
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
|
|---|---|---|---|---|
|
Geometric Mean Ratio of hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
44/76-SL strain (N=501,507,262,236)
|
58 Ratio
Interval 52.0 to 64.0
|
83 Ratio
Interval 74.0 to 92.0
|
61 Ratio
Interval 53.0 to 70.0
|
0.91 Ratio
Interval 0.83 to 1.0
|
|
Geometric Mean Ratio of hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
5/99 strain (N=497,494,257,217)
|
430 Ratio
Interval 379.0 to 487.0
|
553 Ratio
Interval 489.0 to 625.0
|
271 Ratio
Interval 231.0 to 318.0
|
1.03 Ratio
Interval 0.86 to 1.22
|
|
Geometric Mean Ratio of hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
NZ98/254 strain (N=504,503,258,238)
|
11 Ratio
Interval 9.28 to 12.0
|
16 Ratio
Interval 14.0 to 19.0
|
10 Ratio
Interval 8.52 to 12.0
|
1.05 Ratio
Interval 0.97 to 1.14
|
SECONDARY outcome
Timeframe: One month after third Men B vaccinationPopulation: PP Population
The percentage of subjects with hSBA titers ≥1:8, following rMenB+OMV NZ vaccination when given concomitantly with routine infant vaccines to when rMenB+OMV NZ and routine vaccines were given separately.
Outcome measures
| Measure |
B+R246
n=556 Participants
Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
|
B246_R357
n=548 Participants
Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
|
B+R234
n=285 Participants
Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
|
R234
n=278 Participants
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
|
|---|---|---|---|---|
|
Percentage of Subjects With hSBA ≥1:8 After Receiving Three Doses of rMenB+OMV NZ Vaccine.
Baseline (44/76-SL strain)N=556,548,285,277
|
4 Percentages of subjects
Interval 3.0 to 6.0
|
3 Percentages of subjects
Interval 2.0 to 5.0
|
4 Percentages of subjects
Interval 2.0 to 7.0
|
2 Percentages of subjects
Interval 1.0 to 5.0
|
|
Percentage of Subjects With hSBA ≥1:8 After Receiving Three Doses of rMenB+OMV NZ Vaccine.
Post vaccination (44/76-SL)N=525,534,273,253
|
99 Percentages of subjects
Interval 98.0 to 100.0
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
99 Percentages of subjects
Interval 97.0 to 100.0
|
2 Percentages of subjects
Interval 0.0 to 4.0
|
|
Percentage of Subjects With hSBA ≥1:8 After Receiving Three Doses of rMenB+OMV NZ Vaccine.
Baseline (5/99 strain)N=551,537,280,275
|
4 Percentages of subjects
Interval 2.0 to 6.0
|
3 Percentages of subjects
Interval 2.0 to 5.0
|
2 Percentages of subjects
Interval 1.0 to 5.0
|
4 Percentages of subjects
Interval 2.0 to 7.0
|
|
Percentage of Subjects With hSBA ≥1:8 After Receiving Three Doses of rMenB+OMV NZ Vaccine.
Post vaccination (5/99 strain)N=527,529,275,236
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
99 Percentages of subjects
Interval 98.0 to 100.0
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
3 Percentages of subjects
Interval 1.0 to 7.0
|
|
Percentage of Subjects With hSBA ≥1:8 After Receiving Three Doses of rMenB+OMV NZ Vaccine.
Baseline(NZ98/254 strain)N=554,543,283,278
|
1 Percentages of subjects
Interval 1.0 to 3.0
|
1 Percentages of subjects
Interval 0.0 to 2.0
|
1 Percentages of subjects
Interval 0.086 to 3.0
|
0.1 Percentages of subjects
Interval 0.0091 to 2.0
|
|
Percentage of Subjects With hSBA ≥1:8 After Receiving Three Doses of rMenB+OMV NZ Vaccine.
Post vaccination(NZ98/254 strain)N=530,534,274,257
|
67 Percentages of subjects
Interval 63.0 to 71.0
|
79 Percentages of subjects
Interval 75.0 to 82.0
|
69 Percentages of subjects
Interval 63.0 to 74.0
|
2 Percentages of subjects
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: One month after third Men B vaccinationPopulation: PP Population
The percentage of subjects with 4-fold rise in hSBA titers at 1 month after 3rd rMenB+OMV NZ vaccination from baseline, when rMenB+OMV NZ was administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately.
Outcome measures
| Measure |
B+R246
n=504 Participants
Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
|
B246_R357
n=507 Participants
Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
|
B+R234
n=262 Participants
Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
|
R234
n=238 Participants
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
|
|---|---|---|---|---|
|
Percentage of Subjects With 4-fold Rise in hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
44/76-SL strain (N=501,507,262,236)
|
97 Percentages of subjects
Interval 96.0 to 99.0
|
99 Percentages of subjects
Interval 97.0 to 99.0
|
98 Percentages of subjects
Interval 96.0 to 99.0
|
1 Percentages of subjects
Interval 0.0 to 4.0
|
|
Percentage of Subjects With 4-fold Rise in hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
5/99 strain (N=497,494,257,217)
|
99 Percentages of subjects
Interval 98.0 to 100.0
|
99 Percentages of subjects
Interval 98.0 to 100.0
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
3 Percentages of subjects
Interval 1.0 to 7.0
|
|
Percentage of Subjects With 4-fold Rise in hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.
NZ98/254 strain (N=504,503,258,238)
|
66 Percentages of subjects
Interval 62.0 to 70.0
|
78 Percentages of subjects
Interval 74.0 to 81.0
|
69 Percentages of subjects
Interval 63.0 to 75.0
|
3 Percentages of subjects
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: 1 month after 3rd vaccinationNon-inferiority of immune response to routine vaccine antigens when routine vaccines were administered concomitantly with rMenB+OMV NZ vaccine \[group B+R234\] to when only routine vaccines were given \[Group R234\] were assessed in terms of percentage of subjects achieving seroconversion for pertussis antigens - Filamentous Hemagglutinin (FHA), Pertactin and Pertussis Toxoid (PT) at 1 month after 3rd vaccination versus baseline. Seroconversion was defined as a 4-fold increase for each pertussis antigen or in those initially seropositive, persistence of the pre-vaccination antibody concentration at least at the same antibody concentration as before vaccination, taking into account the decay of maternal antibodies.
Outcome measures
| Measure |
B+R246
n=239 Participants
Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
|
B246_R357
n=210 Participants
Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
|
B+R234
Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
|
R234
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
|
|---|---|---|---|---|
|
Non-inferiority of Immune Response to Acellular Pertussis Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine.
FHA
|
94 Percentages of subjects
Interval 90.0 to 97.0
|
95 Percentages of subjects
Interval 91.0 to 97.0
|
—
|
—
|
|
Non-inferiority of Immune Response to Acellular Pertussis Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine.
Pertactin
|
92 Percentages of subjects
Interval 88.0 to 95.0
|
95 Percentages of subjects
Interval 91.0 to 97.0
|
—
|
—
|
|
Non-inferiority of Immune Response to Acellular Pertussis Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine.
PT
|
97 Percentages of subjects
Interval 94.0 to 99.0
|
98 Percentages of subjects
Interval 95.0 to 99.0
|
—
|
—
|
Adverse Events
B+R246
Serious events: 63 serious events
Other events: 620 other events
Deaths: 0 deaths
B246_R357
Serious events: 57 serious events
Other events: 623 other events
Deaths: 0 deaths
B+R234
Serious events: 19 serious events
Other events: 316 other events
Deaths: 0 deaths
R234
Serious events: 19 serious events
Other events: 305 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
B+R246
n=625 participants at risk
Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
|
B246_R357
n=627 participants at risk
Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
|
B+R234
n=318 participants at risk
Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
|
R234
n=312 participants at risk
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadentitis
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Congenital, familial and genetic disorders
Congenital musculoskeletal anomaly
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.32%
1/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Congenital, familial and genetic disorders
Craniosynostosis
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Congenital, familial and genetic disorders
Talipes
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Congenital, familial and genetic disorders
Urachal abnormality
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.31%
1/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Eye disorders
Retinal dystrophy
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.31%
1/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Gastrointestinal disorders
Anal fistula
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Gastrointestinal disorders
Diarrhea
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.32%
1/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.32%
1/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.31%
1/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Gastrointestinal disorders
Vomiting
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.94%
3/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
General disorders
Developmental delay
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
General disorders
Hyperpyrexia
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
General disorders
Pyrexia
|
0.80%
5/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.64%
4/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.31%
1/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.32%
1/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.32%
1/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.32%
1/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Bronchiolitis
|
0.32%
2/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.48%
3/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.63%
2/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.96%
3/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Bronchitis
|
0.64%
4/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.96%
6/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.63%
2/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.64%
2/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Bronchopneumonia
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.64%
4/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.32%
1/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Enterovirus infection
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Gatroenteritis
|
1.1%
7/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
1.1%
7/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.63%
2/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
1.3%
4/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Gatroenteritis adenovirus
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Gatroenteritis rotavirus
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
H1N1 influenza
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Influenza
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.32%
1/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Laryngitis
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.31%
1/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.32%
2/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.31%
1/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Lymph gland infection
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Nasopharyngitis
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.31%
1/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Otitis media
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.31%
1/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Pneumonia
|
0.32%
2/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.32%
2/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Pyelonephritis
|
0.48%
3/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.31%
1/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.32%
1/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Sepsis
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.31%
1/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Staphylococcal bacteremia
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.32%
2/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.31%
1/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Urinary tract infection
|
0.48%
3/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.32%
1/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Varicella
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Viral infection
|
0.64%
4/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.32%
1/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Injury, poisoning and procedural complications
Accidental exposure
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.31%
1/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.48%
3/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.31%
1/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.32%
2/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.32%
2/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.31%
1/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Investigations
Blood alkaline phosphatase abnormal
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Investigations
Body temperature increased
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.32%
2/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.31%
1/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.31%
1/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hemangioma
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.31%
1/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Nervous system disorders
Convulsion
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.31%
1/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Nervous system disorders
Crying
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.32%
2/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.32%
1/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Nervous system disorders
Febrile convulsion
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.32%
2/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Nervous system disorders
Hypotonic-hyporesponsive episode
|
0.32%
2/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Nervous system disorders
Petit mal epilepsy
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Psychiatric disorders
Breath holding
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Respiratory, thoracic and mediastinal disorders
Aponetic attack
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.32%
1/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Surgical and medical procedures
Prophylaxis
|
0.00%
0/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Vascular disorders
Kawasaki's disease
|
0.16%
1/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.16%
1/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
0.00%
0/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
Other adverse events
| Measure |
B+R246
n=625 participants at risk
Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
|
B246_R357
n=627 participants at risk
Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
|
B+R234
n=318 participants at risk
Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
|
R234
n=312 participants at risk
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.2%
51/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
15.3%
96/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
11.0%
35/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
13.1%
41/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Nervous system disorders
Somnolence
|
83.7%
523/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
83.7%
525/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
88.7%
282/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
71.8%
224/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
General disorders
Injection Site Induration
|
78.2%
489/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
82.8%
519/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
79.9%
254/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
65.4%
204/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
General disorders
Pyrexia
|
82.2%
514/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
73.7%
462/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
77.4%
246/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
56.4%
176/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
General disorders
Injection Site Erythema
|
85.6%
535/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
88.2%
553/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
85.2%
271/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
73.4%
229/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
General disorders
Injection Site Swelling
|
52.5%
328/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
61.1%
383/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
53.5%
170/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
36.9%
115/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
General disorders
Crying
|
84.2%
526/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
82.3%
516/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
84.3%
268/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
59.9%
187/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
General disorders
Injection Site Pain
|
87.0%
544/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
85.5%
536/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
87.7%
279/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
58.3%
182/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Psychiatric disorders
Irritability
|
86.9%
543/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
84.1%
527/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
90.9%
289/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
70.5%
220/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Psychiatric disorders
Eating disorder
|
75.2%
470/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
75.4%
473/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
78.3%
249/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
51.0%
159/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Gastrointestinal disorders
Diarrhea
|
48.3%
302/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
53.9%
338/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
45.6%
145/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
39.4%
123/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Gastrointestinal disorders
Teething
|
4.8%
30/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
8.1%
51/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
2.2%
7/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
4.2%
13/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
208/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
39.1%
245/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
31.4%
100/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
27.2%
85/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.0%
100/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
22.6%
142/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
15.7%
50/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
15.1%
47/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.6%
29/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
5.6%
35/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
3.8%
12/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
5.4%
17/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
78/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
15.6%
98/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
9.1%
29/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
11.2%
35/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Rhinitis
|
10.7%
67/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
14.5%
91/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
8.8%
28/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
11.5%
36/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Bronchitis
|
11.5%
72/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
13.1%
82/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
9.7%
31/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
7.4%
23/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
12.2%
76/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
11.5%
72/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
7.5%
24/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
5.1%
16/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Conjunctivitis
|
8.5%
53/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
11.5%
72/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
8.2%
26/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
7.1%
22/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Viral Infection
|
6.7%
42/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
8.5%
53/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
5.3%
17/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
8.3%
26/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Ear infection
|
7.7%
48/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
8.3%
52/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
4.7%
15/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
4.5%
14/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
|
Infections and infestations
Gastroenteritis
|
6.4%
40/625 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
7.2%
45/627 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
3.5%
11/318 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
3.8%
12/312 • Solicited and unsolicited AEs were collected for 7 days after each vaccination; SAEs, Medically attended AEs and AEs leading to premature withdrawal were collected throughout the study period.
Of the 1885 enrolled subjects, 1882 received at least one vaccination and provided post-baseline safety data; these subjects were included in the safety analysis (B+R246 \[625\], B246\_R357 \[627\], B+R234 \[318\], R234 \[312\]. Three subjects did not receive any vaccination and were excluded from the safety analysis (B+R246 \[2\], B246\_R357 \[1\]).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60