Trial Outcomes & Findings for Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers (NCT NCT00847145)
NCT ID: NCT00847145
Last Updated: 2015-03-03
Results Overview
Immunogenicity was assessed in terms of the percentage of subjects as measured by serum bactericidal antibody titers ≥1:5 the lower limit of the two-sided 95% confidence interval (CI) was ≥75%, directed against N.meningitidis serogroup B reference strains H44/76-SL , NZ98/254, 5/99, one month after the booster (fourth) dose of meningococcal B vaccine with or without the concomitant Measles, Mumps, Rubella, Varicella (MMRV) vaccine in toddlers who were previously vaccinated with three doses of Meningococcal B vaccine.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2249 participants
Primary outcome timeframe
one month after the booster (fourth) dose
Results posted on
2015-03-03
Participant Flow
Subjects were enrolled at 15 sites in Finland, 12 sites in Germany, 5 sites in Austria, 27 sites in Czech Republic and 6 sites in Italy.
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
12B12M (1a)
Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (1b)
Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
|
12M13B15B (2a)
Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
|
12M12B14B (2b)
Previously in the parent study (NCT00657709) subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
|
12B12M (3a)
Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (3b)
Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
|
12B12M_C (4a)
Previously in the parent study (NCT00657709) subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M_C (4b)
Previously in the parent study (NCT00657709) subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
629
|
633
|
285
|
117
|
137
|
156
|
152
|
140
|
|
Overall Study
COMPLETED
|
623
|
627
|
274
|
116
|
131
|
152
|
143
|
136
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
11
|
1
|
6
|
4
|
9
|
4
|
Reasons for withdrawal
| Measure |
12B12M (1a)
Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (1b)
Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
|
12M13B15B (2a)
Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
|
12M12B14B (2b)
Previously in the parent study (NCT00657709) subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
|
12B12M (3a)
Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (3b)
Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
|
12B12M_C (4a)
Previously in the parent study (NCT00657709) subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M_C (4b)
Previously in the parent study (NCT00657709) subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
AE or Death
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
6
|
1
|
0
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
1
|
0
|
4
|
4
|
8
|
2
|
|
Overall Study
Inappropriate enrollment
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
3
|
0
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers
Baseline characteristics by cohort
| Measure |
12B12M (1a)
n=629 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (1b)
n=633 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
|
12M13B15B (2a)
n=285 Participants
Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
|
12M12B14B (2b)
n=117 Participants
Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
|
12B12M (3a)
n=137 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (3b)
n=156 Participants
Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
|
12B12M_C (4a)
n=152 Participants
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M_C (4b)
n=140 Participants
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
|
Total
n=2249 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
12.3 years
STANDARD_DEVIATION 0.5 • n=93 Participants
|
12.3 years
STANDARD_DEVIATION 0.5 • n=4 Participants
|
12.3 years
STANDARD_DEVIATION 0.5 • n=27 Participants
|
12.3 years
STANDARD_DEVIATION 0.5 • n=483 Participants
|
12.2 years
STANDARD_DEVIATION 0.5 • n=36 Participants
|
12.2 years
STANDARD_DEVIATION 0.4 • n=10 Participants
|
12.2 years
STANDARD_DEVIATION 0.5 • n=115 Participants
|
12.2 years
STANDARD_DEVIATION 0.4 • n=40 Participants
|
12.3 years
STANDARD_DEVIATION 0.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
290 Participants
n=93 Participants
|
330 Participants
n=4 Participants
|
131 Participants
n=27 Participants
|
55 Participants
n=483 Participants
|
75 Participants
n=36 Participants
|
81 Participants
n=10 Participants
|
62 Participants
n=115 Participants
|
73 Participants
n=40 Participants
|
1097 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
339 Participants
n=93 Participants
|
303 Participants
n=4 Participants
|
154 Participants
n=27 Participants
|
62 Participants
n=483 Participants
|
62 Participants
n=36 Participants
|
75 Participants
n=10 Participants
|
90 Participants
n=115 Participants
|
67 Participants
n=40 Participants
|
1152 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: one month after the booster (fourth) dosePopulation: The analysis was done on Per Protocol (PP) population - subjects who received all doses of vaccine in parent \& present study, provided evaluable serum samples at 1 month after booster dose or 1 month after 2nd dose, blood draw at 1 month after 3rd injection at 6 months in parent \& visit 1 blood draw in present study, had no major protocol violation
Immunogenicity was assessed in terms of the percentage of subjects as measured by serum bactericidal antibody titers ≥1:5 the lower limit of the two-sided 95% confidence interval (CI) was ≥75%, directed against N.meningitidis serogroup B reference strains H44/76-SL , NZ98/254, 5/99, one month after the booster (fourth) dose of meningococcal B vaccine with or without the concomitant Measles, Mumps, Rubella, Varicella (MMRV) vaccine in toddlers who were previously vaccinated with three doses of Meningococcal B vaccine.
Outcome measures
| Measure |
12B12M (1a)
n=211 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (1b)
n=215 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
|
Men246
Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
|
Routine246
Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age \[12M13B15B (2a)\]; 12 and 14 months \[12M12B14B (2b)\] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
|
|---|---|---|---|---|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
Strain 44/76-SL (Baseline) (N=211, 215)
|
81 Percentages of subjects
Interval 75.0 to 86.0
|
82 Percentages of subjects
Interval 77.0 to 87.0
|
—
|
—
|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
One month after booster (N=210, 212)
|
100 Percentages of subjects
Interval 98.0 to 100.0
|
100 Percentages of subjects
Interval 98.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
Strain 5/99 (Baseline) (N=210, 213)
|
98 Percentages of subjects
Interval 95.0 to 99.0
|
100 Percentages of subjects
Interval 97.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
One month after booster (N=209, 212)
|
100 Percentages of subjects
Interval 98.0 to 100.0
|
100 Percentages of subjects
Interval 98.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
Strain NZ98/254 (Baseline) (N=211, 215)
|
19 Percentages of subjects
Interval 14.0 to 25.0
|
24 Percentages of subjects
Interval 19.0 to 30.0
|
—
|
—
|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
One month after booster (N=211, 213)
|
97 Percentages of subjects
Interval 93.0 to 99.0
|
94 Percentages of subjects
Interval 90.0 to 97.0
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after booster (fourth) dosePopulation: This analysis was done on Per Protocol (PP) population.
Immunogenicity was assessed to demonstrate non-inferiority in terms of percentages of subjects as measured by antibody responses against MMRV vaccine when given concomitantly with the booster (fourth) dose of rMenB+OMV NZ vaccine at 12 months of age when compared to MMRV vaccine when given alone. The specified cut-off levels for the vaccine antigens : for measles antigen is ≥255mIU/mL, Mumps antigen is ≥10 Enzyme Linked Immunosorbent Assay(ELISA) Antibody(Ab) units, Rubella antigen is ≥10 IU/mL, Varicella antigen is ≥1.25 glycoprotein (gp) ELISA units/ml (seroconversion) and varicella antigen is ≥5 gp ELISA units/ml (seroprotection.
Outcome measures
| Measure |
12B12M (1a)
n=163 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (1b)
n=156 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
|
Men246
Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
|
Routine246
Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age \[12M13B15B (2a)\]; 12 and 14 months \[12M12B14B (2b)\] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
|
|---|---|---|---|---|
|
Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination
Measles strain Schwarz≥255mIU/mLBaselineN=152,147
|
0 Percentages of subjects
Interval 0.0 to 2.0
|
0 Percentages of subjects
Interval 0.0 to 2.0
|
—
|
—
|
|
Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination
2 months after MMRV vaccine (N=151,146)
|
98 Percentages of subjects
Interval 94.0 to 100.0
|
99 Percentages of subjects
Interval 96.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination
Mumps(strain RIT4385)≥10 U/mL(Baseline)(N=157,152)
|
0 Percentages of subjects
Interval 0.0 to 2.0
|
0 Percentages of subjects
Interval 0.0 to 2.0
|
—
|
—
|
|
Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination
2 months after MMRV vaccine (N=156, 151)
|
96 Percentages of subjects
Interval 92.0 to 99.0
|
96 Percentages of subjects
Interval 92.0 to 99.0
|
—
|
—
|
|
Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination
Rubella (Wistar RA 27/3) ≥10 (Bas N=163,156)
|
0 Percentages of subjects
Interval 0.0 to 2.0
|
0 Percentages of subjects
Interval 0.0 to 2.0
|
—
|
—
|
|
Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination
2 months after MMRV vaccine (N=162, 155)
|
99 Percentages of subjects
Interval 96.0 to 100.0
|
100 Percentages of subjects
Interval 98.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination
Varicella (Oka, ≥1.25), Bas (N=147,141)
|
0 Percentages of subjects
Interval 0.0 to 2.0
|
0 Percentages of subjects
Interval 0.0 to 3.0
|
—
|
—
|
|
Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination
2 months after MMRV vaccine (N=146,140)
|
97 Percentages of subjects
Interval 93.0 to 99.0
|
99 Percentages of subjects
Interval 95.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination
Varicella (Oka, ≥5), Bas (N=147,141)
|
0 Percentages of subjects
Interval 0.0 to 2.0
|
0 Percentages of subjects
Interval 0.0 to 3.0
|
—
|
—
|
|
Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination
VarII 2 months after MMRV vaccine (N=146, 140)
|
79 Percentages of subjects
Interval 71.0 to 85.0
|
81 Percentages of subjects
Interval 73.0 to 87.0
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after booster (fourth) vaccination.Population: This analysis was done on PP population.
The human serum bactericidal antibody (hSBA) titer responses, one month after receiving booster dose or rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).
Outcome measures
| Measure |
12B12M (1a)
n=211 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (1b)
n=215 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
|
Men246
Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
|
Routine246
Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age \[12M13B15B (2a)\]; 12 and 14 months \[12M12B14B (2b)\] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
|
|---|---|---|---|---|
|
The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
Strain 44/76-SL (Baseline)
|
11 Titers
Interval 9.27 to 12.0
|
10 Titers
Interval 9.11 to 12.0
|
—
|
—
|
|
The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
1 Month after booster (N=210, 212)
|
139 Titers
Interval 123.0 to 156.0
|
119 Titers
Interval 105.0 to 133.0
|
—
|
—
|
|
The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
Strain 5/99 (N=210, 213)
|
81 Titers
Interval 71.0 to 93.0
|
81 Titers
Interval 71.0 to 92.0
|
—
|
—
|
|
The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
1 Month after booster (N=209, 212)
|
1503 Titers
Interval 1339.0 to 1686.0
|
1429 Titers
Interval 1274.0 to 1603.0
|
—
|
—
|
|
The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
Strain NZ98/254 (N=211, 215)
|
2.07 Titers
Interval 1.8 to 2.38
|
2.21 Titers
Interval 1.92 to 2.55
|
—
|
—
|
|
The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
1 Month after booster (N=211,213)
|
39 Titers
Interval 33.0 to 46.0
|
32 Titers
Interval 27.0 to 37.0
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after third vaccination and pre dose fourth (booster) vaccinationThe immunogenicity was assessed as the persistence of bactericidal antibodies at 12 months of age (pre-dose 4) who previously received three doses of rMenB+OMV NZ in the parent study as measured by hSBA GMTs directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.
Outcome measures
| Measure |
12B12M (1a)
n=139 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (1b)
n=133 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
|
Men246
n=272 Participants
Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
|
Routine246
n=51 Participants
Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age \[12M13B15B (2a)\]; 12 and 14 months \[12M12B14B (2b)\] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
|
|---|---|---|---|---|
|
Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)
Strain 44/76-SL (Baseline) N=134, 131, 265,49
|
1.15 Titers
Interval 1.05 to 1.27
|
1.15 Titers
Interval 1.05 to 1.27
|
1.15 Titers
Interval 1.08 to 1.24
|
1.14 Titers
Interval 0.99 to 1.32
|
|
Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)
1 M after 3rd vac.in parent study N=139,133,272,51
|
91 Titers
Interval 81.0 to 104.0
|
83 Titers
Interval 73.0 to 94.0
|
87 Titers
Interval 79.0 to 95.0
|
1.19 Titers
Interval 1.07 to 1.33
|
|
Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)
Pre-Boodster vac.in present study N=139,133,272,51
|
11 Titers
Interval 9.0 to 12.0
|
10 Titers
Interval 8.7 to 12.0
|
10 Titers
Interval 9.28 to 12.0
|
1.08 Titers
Interval 0.99 to 1.17
|
|
Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)
Strain 5/99 (Baseline) N=132,129,261,49
|
1.13 Titers
Interval 1.01 to 1.26
|
1.24 Titers
Interval 1.11 to 1.39
|
1.18 Titers
Interval 1.09 to 1.28
|
1.11 Titers
Interval 1.01 to 1.22
|
|
Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)
1M after 3rd vac. in parent study N=139,133,272,51
|
615 Titers
Interval 538.0 to 704.0
|
620 Titers
Interval 540.0 to 712.0
|
617 Titers
Interval 560.0 to 680.0
|
1 Titers
Interval 1.0 to 1.0
|
|
Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)
Pre-Booster vac.in present study N=139,133,272,51
|
85 Titers
Interval 72.0 to 100.0
|
79 Titers
Interval 67.0 to 94.0
|
82 Titers
Interval 73.0 to 92.0
|
1.03 Titers
Interval 0.97 to 1.09
|
|
Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)
Strain NZ98/254 (Baseline) N=135,130,265,49
|
1.05 Titers
Interval 0.98 to 1.13
|
1.12 Titers
Interval 1.04 to 1.21
|
1.09 Titers
Interval 1.03 to 1.15
|
1 Titers
Interval 1.0 to 1.0
|
|
Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)
1M after 3rd vac. in parent study.N=139,132,271,52
|
12 Titers
Interval 10.0 to 15.0
|
14 Titers
Interval 12.0 to 17.0
|
13 Titers
Interval 11.0 to 15.0
|
1.07 Titers
Interval 0.94 to 1.21
|
|
Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)
Pre-booster vac in present study. N=139,132,271,52
|
2.04 Titers
Interval 1.72 to 2.43
|
2.02 Titers
Interval 1.69 to 2.42
|
2.03 Titers
Interval 1.79 to 2.3
|
1 Titers
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: One month post vaccination and pe-booster (fourth) dose vaccinationPopulation: The analysis was done on PP population.
Immunogenicity was assessed to evaluate the persistence in terms of percentages of subjects with hSBA titers ≥ 1:5, previously received three doses of rMenB+OMV NZ directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.
Outcome measures
| Measure |
12B12M (1a)
n=139 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (1b)
n=133 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
|
Men246
n=272 Participants
Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
|
Routine246
n=51 Participants
Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age \[12M13B15B (2a)\]; 12 and 14 months \[12M12B14B (2b)\] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
|
|---|---|---|---|---|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)
44/76-SL Baseline in present studyN=134,131,265,49
|
3 Percentages of subjects
Interval 1.0 to 7.0
|
3 Percentages of subjects
Interval 1.0 to 8.0
|
3 Percentages of subjects
Interval 1.0 to 6.0
|
4 Percentages of subjects
Interval 0.0 to 14.0
|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)
1 M after 3rd vac in parent study.N=139,133,272,51
|
100 Percentages of subjects
Interval 97.0 to 100.0
|
99 Percentages of subjects
Interval 96.0 to 100.0
|
100 Percentages of subjects
Interval 98.0 to 100.0
|
0 Percentages of subjects
Interval 0.0 to 7.0
|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)
Pre-booster vac. in present study.N=139,133,272,51
|
81 Percentages of subjects
Interval 73.0 to 87.0
|
82 Percentages of subjects
Interval 74.0 to 88.0
|
81 Percentages of subjects
Interval 76.0 to 86.0
|
2 Percentages of subjects
Interval 0.05 to 10.0
|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)
5/99 Baseline in parent study N=132,129,261,49
|
4 Percentages of subjects
Interval 1.0 to 9.0
|
5 Percentages of subjects
Interval 2.0 to 10.0
|
4 Percentages of subjects
Interval 2.0 to 7.0
|
2 Percentages of subjects
Interval 0.052 to 11.0
|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)
1M after 3rd vac in parent study N=139,133,272,51
|
100 Percentages of subjects
Interval 97.0 to 100.0
|
99 Percentages of subjects
Interval 96.0 to 100.0
|
100 Percentages of subjects
Interval 98.0 to 100.0
|
0 Percentages of subjects
Interval 0.0 to 7.0
|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)
Pre-Boostervac.in present study N=139,133,272,51
|
98 Percentages of subjects
Interval 94.0 to 100.0
|
100 Percentages of subjects
Interval 97.0 to 100.0
|
99 Percentages of subjects
Interval 97.0 to 100.0
|
0 Percentages of subjects
Interval 0.0 to 7.0
|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)
NZ98/254 Baseline in parent study N=135,130,265,49
|
1 Percentages of subjects
Interval 0.019 to 4.0
|
4 Percentages of subjects
Interval 1.0 to 9.0
|
2 Percentages of subjects
Interval 1.0 to 5.0
|
0 Percentages of subjects
Interval 0.0 to 7.0
|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)
1 M after 3rd vac. in parent studyN=139,132,271,52
|
81 Percentages of subjects
Interval 74.0 to 87.0
|
85 Percentages of subjects
Interval 78.0 to 90.0
|
83 Percentages of subjects
Interval 78.0 to 87.0
|
2 Percentages of subjects
Interval 0.049 to 10.0
|
|
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)
Pre-Booster vac in present study N=139,132,271,52
|
21 Percentages of subjects
Interval 14.0 to 29.0
|
20 Percentages of subjects
Interval 13.0 to 28.0
|
20 Percentages of subjects
Interval 16.0 to 26.0
|
0 Percentages of subjects
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: one month after booster (fourth) dose vaccination and pre-fourth dose vaccinationPopulation: This analysis was done on the PP population.
The immunogenicity was assessed to demonstrate the induction of immunological memory in subjects who were previously received three doses of rMenB+OMV NZ as measured by SBA GMT response in comparison to the fourth dose of rMenB+OMV NZ at 12 months of age ( 12B12M(1a) group) to the response in subjects (12M12B14B 0 who received a single dose of rMenB+OMV NZ vaccine.
Outcome measures
| Measure |
12B12M (1a)
n=211 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (1b)
n=72 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
|
Men246
Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
|
Routine246
Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age \[12M13B15B (2a)\]; 12 and 14 months \[12M12B14B (2b)\] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
|
|---|---|---|---|---|
|
Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory)
44/76-SL (Baseline) (N=211, 71)
|
11 Titers
Interval 9.32 to 12.0
|
1.18 Titers
Interval 0.96 to 1.46
|
—
|
—
|
|
Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory)
1 M after Booster or 1st rMenB (N=210, 71)
|
140 Titers
Interval 123.0 to 159.0
|
15 Titers
Interval 12.0 to 19.0
|
—
|
—
|
|
Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory)
5/99 (Baseline) (N=210, 71)
|
83 Titers
Interval 73.0 to 93.0
|
1 Titers
Interval 0.81 to 1.24
|
—
|
—
|
|
Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory)
1 M after Booster or 1sr rMenB (N=209, 72)
|
1538 Titers
Interval 1337.0 to 1769.0
|
58 Titers
Interval 46.0 to 74.0
|
—
|
—
|
|
Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory)
NZ98/254 (Baseline) (N=211, 71)
|
2.05 Titers
Interval 1.83 to 2.31
|
1.03 Titers
Interval 0.84 to 1.26
|
—
|
—
|
|
Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory)
1M after Booster or 1st rMenB (N=211, 72)
|
39 Titers
Interval 34.0 to 46.0
|
4.18 Titers
Interval 3.18 to 5.5
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after the second dose.Population: The analysis was done on the SBA PP Catch-up population.
The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed by SBA GMTs one month after the second dose.
Outcome measures
| Measure |
12B12M (1a)
n=164 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (1b)
n=68 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
|
Men246
Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
|
Routine246
Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age \[12M13B15B (2a)\]; 12 and 14 months \[12M12B14B (2b)\] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
|
|---|---|---|---|---|
|
SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule
Strain H44/76, Baseline (N=161,67)
|
1.24 Titers
Interval 1.15 to 1.35
|
1.22 Titers
Interval 1.07 to 1.38
|
—
|
—
|
|
SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule
1 M after 2nd Vac. (N=163, 67)
|
271 Titers
Interval 237.0 to 310.0
|
248 Titers
Interval 201.0 to 306.0
|
—
|
—
|
|
SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule
Strain 5/99, Baseline (N=160, 67)
|
1.06 Titers
Interval 1.0 to 1.13
|
1.03 Titers
Interval 0.94 to 1.13
|
—
|
—
|
|
SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule
1 M after 2nd Vac. (N=164, 67)
|
599 Titers
Interval 520.0 to 690.0
|
627 Titers
Interval 502.0 to 783.0
|
—
|
—
|
|
SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule
Strain NZ98/254, Baseline (N=162, 67)
|
1.03 Titers
Interval 0.98 to 1.07
|
1.03 Titers
Interval 0.97 to 1.1
|
—
|
—
|
|
SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule
1M after 2nd Vac. (N=164, 68)
|
43 Titers
Interval 38.0 to 49.0
|
32 Titers
Interval 26.0 to 40.0
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after the second dose.The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed as percentages of subjects with SBA titers ≥1:5 one month after the second dose.
Outcome measures
| Measure |
12B12M (1a)
n=164 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (1b)
n=68 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
|
Men246
Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
|
Routine246
Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age \[12M13B15B (2a)\]; 12 and 14 months \[12M12B14B (2b)\] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
|
|---|---|---|---|---|
|
Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule
Strain H44/76, Baseline (N=161,67)
|
5 Percentages of Subjects
Interval 2.0 to 10.0
|
3 Percentages of Subjects
Interval 0.0 to 10.0
|
—
|
—
|
|
Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule
1 M after 2nd Vac. (N=163, 67)
|
100 Percentages of Subjects
Interval 98.0 to 100.0
|
100 Percentages of Subjects
Interval 95.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule
Strain 5/99, Baseline (N=160, 67)
|
1 Percentages of Subjects
Interval 0.0 to 4.0
|
1 Percentages of Subjects
Interval 0.038 to 8.0
|
—
|
—
|
|
Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule
1 M after 2nd Vac. (N=164, 67)
|
100 Percentages of Subjects
Interval 98.0 to 100.0
|
100 Percentages of Subjects
Interval 95.0 to 100.0
|
—
|
—
|
|
Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule
Strain NZ98/254, Baseline (N=162, 67)
|
1 Percentages of Subjects
Interval 0.016 to 3.0
|
0 Percentages of Subjects
Interval 0.0 to 5.0
|
—
|
—
|
|
Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule
1M after 2nd Vac. (N=164, 68)
|
100 Percentages of Subjects
Interval 98.0 to 100.0
|
96 Percentages of Subjects
Interval 88.0 to 99.0
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after the fourth (booster) dose.Population: The analysis was done on the SBA PP Booster population.
The immune response against vaccine antigen 287-953 was measured by ELISA, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).
Outcome measures
| Measure |
12B12M (1a)
n=213 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (1b)
n=216 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
|
Men246
Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
|
Routine246
Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age \[12M13B15B (2a)\]; 12 and 14 months \[12M12B14B (2b)\] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
|
|---|---|---|---|---|
|
ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months
Baseline (N=212,216)
|
390 IU/mL
Interval 351.0 to 433.0
|
389 IU/mL
Interval 349.0 to 434.0
|
—
|
—
|
|
ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months
1 M after Booster (N=213, 214)
|
6225 IU/mL
Interval 5571.0 to 6956.0
|
5608 IU/mL
Interval 5111.0 to 6154.0
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after the first dose and one month after the second dose.Population: The analysis was done on the SBA PP Catch-up population.
The immune response against vaccine antigen 287-953was measured by ELISA one month after the first dose and one month after the second dose of a two-dose catch-up regimens (12M13B15B and 12M12B14B) in toddlers.
Outcome measures
| Measure |
12B12M (1a)
n=165 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (1b)
n=68 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
|
Men246
Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
|
Routine246
Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age \[12M13B15B (2a)\]; 12 and 14 months \[12M12B14B (2b)\] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
|
|---|---|---|---|---|
|
ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers
Baseline (N=162,66)
|
20 IU/mL
Interval 20.0 to 21.0
|
22 IU/mL
Interval 19.0 to 24.0
|
—
|
—
|
|
ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers
1 M after 1st Vac. (N=162,64)
|
113 IU/mL
Interval 95.0 to 136.0
|
120 IU/mL
Interval 88.0 to 164.0
|
—
|
—
|
|
ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers
1 M after 2nd Vac.
|
5698 IU/mL
Interval 5030.0 to 6454.0
|
7154 IU/mL
Interval 5880.0 to 8704.0
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after the fourth (booster) dose.Population: The analysis was done on the SBA PP Booster population.
The immune response was measured as percentages of subjects with SBA ≥ 1:5 (95% CI) against strain M10713, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).
Outcome measures
| Measure |
12B12M (1a)
n=19 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (1b)
n=27 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
|
Men246
Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
|
Routine246
Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age \[12M13B15B (2a)\]; 12 and 14 months \[12M12B14B (2b)\] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
|
|---|---|---|---|---|
|
Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months
Pre-Booster Vac.
|
84 Percentages of Subjects
Interval 60.0 to 97.0
|
59 Percentages of Subjects
Interval 39.0 to 78.0
|
—
|
—
|
|
Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months
1 Month After Booster
|
100 Percentages of Subjects
Interval 82.0 to 100.0
|
100 Percentages of Subjects
Interval 87.0 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From day 1 to day 7 after each rMenB+OMV NZ vaccination.Population: Analysis performed on the Safety population.
Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered at 12 months. For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M and Groups 12B13M (1b) and 12B13M (3b) are combined as Group 12B13M.
Outcome measures
| Measure |
12B12M (1a)
n=152 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (1b)
n=138 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
|
Men246
n=765 Participants
Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
|
Routine246
n=789 Participants
Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age \[12M13B15B (2a)\]; 12 and 14 months \[12M12B14B (2b)\] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Any local
|
113 Subjects
|
104 Subjects
|
639 Subjects
|
673 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
MenB Tenderness
|
97 Subjects
|
80 Subjects
|
546 Subjects
|
563 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
MenB Erythema
|
78 Subjects
|
81 Subjects
|
504 Subjects
|
539 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
MenB Induration
|
61 Subjects
|
61 Subjects
|
388 Subjects
|
424 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
MenB Swelling
|
44 Subjects
|
39 Subjects
|
284 Subjects
|
287 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Any systemic
|
133 Subjects
|
117 Subjects
|
695 Subjects
|
671 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Change Eat. Habits
|
61 Subjects
|
44 Subjects
|
312 Subjects
|
318 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Sleepiness
|
64 Subjects
|
60 Subjects
|
362 Subjects
|
355 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Vomiting
|
9 Subjects
|
10 Subjects
|
54 Subjects
|
36 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Diarrhea
|
29 Subjects
|
23 Subjects
|
188 Subjects
|
160 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Irritability
|
89 Subjects
|
75 Subjects
|
560 Subjects
|
540 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Unusual Crying
|
48 Subjects
|
48 Subjects
|
327 Subjects
|
294 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Rash
|
8 Subjects
|
7 Subjects
|
57 Subjects
|
56 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Rash Oth.to Fever
|
6 Subjects
|
0 Subjects
|
31 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Rash Urt.to Fever
|
2 Subjects
|
0 Subjects
|
18 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Rash Oth.to Doc.
|
6 Subjects
|
0 Subjects
|
35 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Rash Urt.to Doc.
|
2 Subjects
|
0 Subjects
|
23 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Gland Swelling
|
4 Subjects
|
0 Subjects
|
12 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Gland Par.to Doc.
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Gland Sal.to Doc.
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Med. Att. Fever
|
3 Subjects
|
4 Subjects
|
8 Subjects
|
13 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Fever ( ≥ 38C )
|
87 Subjects
|
74 Subjects
|
356 Subjects
|
325 Subjects
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Antipyretic Med. Used
|
79 Subjects
|
69 Subjects
|
436 Subjects
|
406 Subjects
|
SECONDARY outcome
Timeframe: From day 1 to day 7 after each rMenB+MV NZ vaccination.Population: Analysis performed on the Safety population.
Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered with a two-dose catch-up schedules (groups 12M13B15B and 12M12B14B).
Outcome measures
| Measure |
12B12M (1a)
n=284 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (1b)
n=117 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
|
Men246
Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
|
Routine246
Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age \[12M13B15B (2a)\]; 12 and 14 months \[12M12B14B (2b)\] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
MenB Induration (2nd vacc)
|
115 Subjects
|
53 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
MenB Swelling (1st vacc)
|
81 Subjects
|
36 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
MenB Swelling (2nd vacc)
|
83 Subjects
|
33 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Any systemic (1st vacc)
|
216 Subjects
|
104 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Change Eat. Habits (1st vacc)
|
96 Subjects
|
44 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Any systemic (2nd vacc)
|
224 Subjects
|
99 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Change Eat. Habits (2nd vacc)
|
83 Subjects
|
43 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Sleepiness (1st vacc)
|
110 Subjects
|
55 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Sleepiness (2nd vacc)
|
106 Subjects
|
48 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Vomiting (1st vacc)
|
14 Subjects
|
2 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Vomiting (2nd vacc)
|
8 Subjects
|
3 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Diarrhea (1st vacc)
|
41 Subjects
|
34 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Any local (1st vacc)
|
211 Subjects
|
92 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Any local (2nd vacc)
|
212 Subjects
|
90 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
MenB Tenderness (1st vacc)
|
158 Subjects
|
67 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
MenB Tenderness (2nd vacc)
|
181 Subjects
|
78 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
MenB Erythema (1st vacc)
|
173 Subjects
|
79 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
MenB Erythema (2nd vacc)
|
159 Subjects
|
70 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
MenB Induration (1st vacc)
|
111 Subjects
|
57 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Diarrhea (2nd vacc)
|
41 Subjects
|
25 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Irritability (1st vacc)
|
168 Subjects
|
82 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Irritability (2nd vacc)
|
153 Subjects
|
73 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Unusual Crying (1st vacc)
|
80 Subjects
|
41 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Unusual Crying (2nd vacc)
|
74 Subjects
|
42 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Rash (1st vacc)
|
13 Subjects
|
9 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Rash (2nd vacc)
|
10 Subjects
|
4 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Rash Oth.to Fever (1st vacc)
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Rash Oth.to Fever (2nd vacc)
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Rash Urt.to Fever (1st vacc)
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Rash Urt.to Fever (2nd vacc)
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Rash Oth.to Doc. (1st vacc)
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Rash Oth.to Doc. (2nd vacc)
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Rash Urt.to Doc. (1st vacc)
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Rash Urt.to Doc. (2nd vacc)
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Gland Swelling (1st vacc)
|
0 Subjects
|
1 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Gland Swelling (2nd vacc)
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Gland Par.to Doc. (1st vacc)
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Gland Par.to Doc. (2nd vacc)
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Gland Sal.to Doc. (1st vacc)
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Gland Sal.to Doc. (2nd vacc)
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Med. Att. Fever (1st vacc)
|
0 Subjects
|
1 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Med. Att. Fever (2nd vacc)
|
2 Subjects
|
2 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Fever (≥ 38C) (1st vacc)
|
103 Subjects
|
54 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Fever (≥ 38C) (2nd vacc)
|
97 Subjects
|
50 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Antipyr. Med. Used (1st vacc)
|
119 Subjects
|
67 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Antipyretic Med. Used (2nd vacc)
|
107 Subjects
|
58 Subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: From day 1 to day 7 after MMRV vaccination.Population: Analysis performed on the Safety population.
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M\_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.
Outcome measures
| Measure |
12B12M (1a)
n=284 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (1b)
n=117 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
|
Men246
n=152 Participants
Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
|
Routine246
n=760 Participants
Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age \[12M13B15B (2a)\]; 12 and 14 months \[12M12B14B (2b)\] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age
MMRV Tenderness
|
56 Subjects
|
39 Subjects
|
68 Subjects
|
353 Subjects
|
|
Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age
MMRV Erythema
|
120 Subjects
|
52 Subjects
|
60 Subjects
|
345 Subjects
|
|
Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age
MMRV Induration
|
53 Subjects
|
18 Subjects
|
30 Subjects
|
161 Subjects
|
|
Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age
MMRV Swelling
|
31 Subjects
|
11 Subjects
|
28 Subjects
|
122 Subjects
|
SECONDARY outcome
Timeframe: From day 8 to day 28 after MMRV vaccination.Population: Analysis performed on the Safety population.
Safety was assessed as the number of subjects who reported solicited systemic reactions from day 8 through day 28 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M\_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.
Outcome measures
| Measure |
12B12M (1a)
n=284 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
|
12B13M (1b)
n=117 Participants
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
|
Men246
n=152 Participants
Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
|
Routine246
n=760 Participants
Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age \[12M13B15B (2a)\]; 12 and 14 months \[12M12B14B (2b)\] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age
Rash
|
50 Subjects
|
23 Subjects
|
17 Subjects
|
147 Subjects
|
|
Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age
Rash Oth.to Fever
|
6 Subjects
|
3 Subjects
|
4 Subjects
|
19 Subjects
|
|
Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age
Rash Urt.to Fever
|
4 Subjects
|
1 Subjects
|
2 Subjects
|
14 Subjects
|
|
Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age
Rash Oth.to Doc.
|
3 Subjects
|
1 Subjects
|
3 Subjects
|
10 Subjects
|
|
Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age
Rash Urt.to Doc.
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age
Gland Swelling
|
8 Subjects
|
3 Subjects
|
5 Subjects
|
20 Subjects
|
|
Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age
Gland Par.to Doc.
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age
Gland Sal.to Doc.
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age
Med. Att. Fever
|
19 Subjects
|
6 Subjects
|
15 Subjects
|
54 Subjects
|
|
Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age
Fever ( ≥ 38C )
|
131 Subjects
|
46 Subjects
|
62 Subjects
|
338 Subjects
|
|
Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age
Antipyretic Med. Used
|
119 Subjects
|
55 Subjects
|
48 Subjects
|
324 Subjects
|
Adverse Events
12B12M
Serious events: 28 serious events
Other events: 754 other events
Deaths: 0 deaths
12B13M
Serious events: 40 serious events
Other events: 760 other events
Deaths: 0 deaths
12M13B15B (2a)
Serious events: 27 serious events
Other events: 282 other events
Deaths: 0 deaths
12M12B14B (2b)
Serious events: 9 serious events
Other events: 116 other events
Deaths: 0 deaths
12B12M_C (4a)
Serious events: 7 serious events
Other events: 145 other events
Deaths: 0 deaths
12B13M_C (4b)
Serious events: 2 serious events
Other events: 132 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
12B12M
n=765 participants at risk
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
This group is a combination of Groups 12B12M (1a) and 12B12M (3a) for safety data analysis purposes.
|
12B13M
n=789 participants at risk
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
This group is a combination of Groups 12B13M (1b) and 12B13M (3b) for safety data analysis purposes.
|
12M13B15B (2a)
n=284 participants at risk
Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
2a - Routine and rMenB+OMV NZ vaccines: One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.
|
12M12B14B (2b)
n=117 participants at risk
Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
2b - rMenB+OMV NZ and routine vaccines: Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.
|
12B12M_C (4a)
n=152 participants at risk
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
4a- rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
|
12B13M_C (4b)
n=139 participants at risk
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
4b - rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
|
|---|---|---|---|---|---|---|
|
Vascular disorders
Kawasaki's disease
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Surgical and medical procedures
Strabismus correction
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
General disorders
Dysplasia
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.66%
1/152 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
General disorders
Hernia
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
General disorders
Pyrexia
|
0.13%
1/765 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.13%
1/765 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.25%
2/789 • Number of events 2 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.13%
1/765 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Foreign body aspiration
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.85%
1/117 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.13%
1/765 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.85%
1/117 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.85%
1/117 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.13%
1/765 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Nervous system disorders
Febrile convulsion
|
0.52%
4/765 • Number of events 4 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.85%
1/117 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.66%
1/152 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.72%
1/139 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Nervous system disorders
Partial seizures
|
0.13%
1/765 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.13%
1/765 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.13%
1/765 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.85%
1/117 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.26%
2/765 • Number of events 2 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.66%
1/152 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.13%
1/765 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.85%
1/117 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Musculoskeletal and connective tissue disorders
Growth retardation
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 2 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Abscess
|
0.13%
1/765 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Bronchitis
|
0.78%
6/765 • Number of events 8 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.38%
3/789 • Number of events 3 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
1.1%
3/284 • Number of events 3 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.66%
1/152 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.38%
3/789 • Number of events 3 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.66%
1/152 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.66%
1/152 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Cellulitis orbital
|
0.13%
1/765 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.66%
1/152 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Exanthema subitum
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.25%
2/789 • Number of events 2 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.70%
2/284 • Number of events 2 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.85%
1/117 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.66%
1/152 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.85%
1/117 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Laryngitis
|
0.52%
4/765 • Number of events 4 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.51%
4/789 • Number of events 4 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.70%
2/284 • Number of events 2 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.85%
1/117 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Otitis media
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.25%
2/789 • Number of events 2 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.66%
1/152 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.13%
1/765 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.51%
4/789 • Number of events 4 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
1.4%
4/284 • Number of events 4 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Pyelonephritis
|
0.13%
1/765 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.25%
2/789 • Number of events 2 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.35%
1/284 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.85%
1/117 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.70%
2/284 • Number of events 2 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/765 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.72%
1/139 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Tracheobronchitis
|
0.13%
1/765 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.13%
1/765 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/789 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Urinary tract infection
|
0.13%
1/765 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Viral infection
|
0.13%
1/765 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.13%
1/789 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/284 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
Other adverse events
| Measure |
12B12M
n=765 participants at risk
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
This group is a combination of Groups 12B12M (1a) and 12B12M (3a) for safety data analysis purposes.
|
12B13M
n=789 participants at risk
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
This group is a combination of Groups 12B13M (1b) and 12B13M (3b) for safety data analysis purposes.
|
12M13B15B (2a)
n=284 participants at risk
Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
2a - Routine and rMenB+OMV NZ vaccines: One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.
|
12M12B14B (2b)
n=117 participants at risk
Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
2b - rMenB+OMV NZ and routine vaccines: Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.
|
12B12M_C (4a)
n=152 participants at risk
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
4a- rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
|
12B13M_C (4b)
n=139 participants at risk
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
4b - rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
33/765 • Number of events 45 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
5.8%
46/789 • Number of events 51 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
3.9%
11/284 • Number of events 13 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
6.0%
7/117 • Number of events 8 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
5.9%
9/152 • Number of events 15 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
7.9%
11/139 • Number of events 14 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
3.8%
29/765 • Number of events 48 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.51%
4/789 • Number of events 4 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
4.6%
13/284 • Number of events 24 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
3.4%
4/117 • Number of events 6 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
5.3%
8/152 • Number of events 14 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.72%
1/139 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Nervous system disorders
Somnolence
|
47.3%
362/765 • Number of events 599 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
45.0%
355/789 • Number of events 569 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
62.7%
178/284 • Number of events 430 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
59.8%
70/117 • Number of events 154 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
42.1%
64/152 • Number of events 99 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
43.9%
61/139 • Number of events 91 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
General disorders
Crying
|
42.7%
327/765 • Number of events 558 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
37.3%
294/789 • Number of events 467 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
46.5%
132/284 • Number of events 302 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
50.4%
59/117 • Number of events 140 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
31.6%
48/152 • Number of events 86 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
36.0%
50/139 • Number of events 83 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
General disorders
Injection site erythema
|
71.8%
549/765 • Number of events 1891 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
68.3%
539/789 • Number of events 1326 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
75.0%
213/284 • Number of events 1018 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
80.3%
94/117 • Number of events 476 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
60.5%
92/152 • Number of events 316 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
59.0%
82/139 • Number of events 179 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
General disorders
Injection site induration
|
54.8%
419/765 • Number of events 1392 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
53.7%
424/789 • Number of events 1188 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
58.1%
165/284 • Number of events 717 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
66.7%
78/117 • Number of events 325 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
44.1%
67/152 • Number of events 223 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
44.6%
62/139 • Number of events 159 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
General disorders
Injection site pain
|
73.3%
561/765 • Number of events 1648 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
71.4%
563/789 • Number of events 1107 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
78.9%
224/284 • Number of events 759 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
76.1%
89/117 • Number of events 377 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
68.4%
104/152 • Number of events 329 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
58.3%
81/139 • Number of events 165 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
General disorders
Injection site swelling
|
41.8%
320/765 • Number of events 874 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
36.4%
287/789 • Number of events 667 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
44.7%
127/284 • Number of events 418 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
45.3%
53/117 • Number of events 177 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
35.5%
54/152 • Number of events 166 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
28.8%
40/139 • Number of events 94 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
General disorders
Pyrexia
|
66.8%
511/765 • Number of events 1136 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
45.1%
356/789 • Number of events 560 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
73.2%
208/284 • Number of events 584 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
72.6%
85/117 • Number of events 211 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
72.4%
110/152 • Number of events 256 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
57.6%
80/139 • Number of events 125 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Psychiatric disorders
Irritability
|
73.5%
562/765 • Number of events 1121 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
68.4%
540/789 • Number of events 996 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
79.6%
226/284 • Number of events 742 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
81.2%
95/117 • Number of events 300 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
58.6%
89/152 • Number of events 199 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
54.7%
76/139 • Number of events 142 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Psychiatric disorders
Eating disorder
|
40.9%
313/765 • Number of events 630 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
40.3%
318/789 • Number of events 582 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
54.9%
156/284 • Number of events 444 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
53.8%
63/117 • Number of events 152 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
40.1%
61/152 • Number of events 117 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
32.4%
45/139 • Number of events 84 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.4%
194/765 • Number of events 342 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
21.7%
171/789 • Number of events 268 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
32.4%
92/284 • Number of events 215 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
41.0%
48/117 • Number of events 101 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
20.4%
31/152 • Number of events 57 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
18.0%
25/139 • Number of events 38 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Gastrointestinal disorders
Teething
|
1.7%
13/765 • Number of events 13 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
1.5%
12/789 • Number of events 13 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
7.0%
20/284 • Number of events 22 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
2.6%
3/117 • Number of events 3 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
1.3%
2/152 • Number of events 2 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
1.4%
2/139 • Number of events 2 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Gastrointestinal disorders
Vomiting
|
7.3%
56/765 • Number of events 78 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
4.9%
39/789 • Number of events 53 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
13.4%
38/284 • Number of events 52 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
4.3%
5/117 • Number of events 7 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
7.2%
11/152 • Number of events 12 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
7.9%
11/139 • Number of events 21 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.3%
178/765 • Number of events 310 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
8.2%
65/789 • Number of events 104 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
27.5%
78/284 • Number of events 141 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
25.6%
30/117 • Number of events 61 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
14.5%
22/152 • Number of events 46 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
6.5%
9/139 • Number of events 13 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Bronchitis
|
7.8%
60/765 • Number of events 72 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
7.9%
62/789 • Number of events 78 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
13.4%
38/284 • Number of events 45 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
11.1%
13/117 • Number of events 16 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
7.9%
12/152 • Number of events 20 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
4.3%
6/139 • Number of events 9 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Conjunctivitis
|
6.0%
46/765 • Number of events 57 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
4.8%
38/789 • Number of events 42 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
7.7%
22/284 • Number of events 24 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
4.3%
5/117 • Number of events 5 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
4.6%
7/152 • Number of events 8 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.72%
1/139 • Number of events 2 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Ear infection
|
6.4%
49/765 • Number of events 60 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
7.5%
59/789 • Number of events 100 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
7.0%
20/284 • Number of events 37 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
12.0%
14/117 • Number of events 19 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
9.2%
14/152 • Number of events 18 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
4.3%
6/139 • Number of events 9 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Exanthema subitum
|
2.6%
20/765 • Number of events 21 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
3.4%
27/789 • Number of events 27 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
5.3%
15/284 • Number of events 15 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
2.6%
3/117 • Number of events 3 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
2.6%
4/152 • Number of events 4 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
1.4%
2/139 • Number of events 2 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Gastroenteritis
|
2.7%
21/765 • Number of events 22 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
3.2%
25/789 • Number of events 25 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
3.9%
11/284 • Number of events 11 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
1.7%
2/117 • Number of events 2 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
3.3%
5/152 • Number of events 6 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
5.0%
7/139 • Number of events 7 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Laryngitis
|
3.4%
26/765 • Number of events 26 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
3.4%
27/789 • Number of events 29 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
4.9%
14/284 • Number of events 19 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
6.0%
7/117 • Number of events 7 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
1.3%
2/152 • Number of events 2 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
4.3%
6/139 • Number of events 6 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
49/765 • Number of events 62 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
7.9%
62/789 • Number of events 81 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
13.0%
37/284 • Number of events 48 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
16.2%
19/117 • Number of events 28 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
2.0%
3/152 • Number of events 3 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
5.0%
7/139 • Number of events 7 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Otitis media
|
10.5%
80/765 • Number of events 121 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
10.0%
79/789 • Number of events 133 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
14.8%
42/284 • Number of events 56 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
8.5%
10/117 • Number of events 13 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
5.9%
9/152 • Number of events 10 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
5.0%
7/139 • Number of events 7 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Pharyngitis
|
5.0%
38/765 • Number of events 41 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
6.8%
54/789 • Number of events 64 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
6.7%
19/284 • Number of events 21 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
5.1%
6/117 • Number of events 6 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
4.6%
7/152 • Number of events 9 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
3.6%
5/139 • Number of events 6 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Rhinitis
|
3.9%
30/765 • Number of events 35 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
4.8%
38/789 • Number of events 43 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
9.2%
26/284 • Number of events 35 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
6.0%
7/117 • Number of events 7 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
2.0%
3/152 • Number of events 3 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
2.9%
4/139 • Number of events 5 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.8%
67/765 • Number of events 83 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
7.5%
59/789 • Number of events 71 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
18.0%
51/284 • Number of events 66 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
9.4%
11/117 • Number of events 14 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
5.3%
8/152 • Number of events 12 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
6.5%
9/139 • Number of events 11 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
|
Infections and infestations
Viral infection
|
4.3%
33/765 • Number of events 35 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
4.6%
36/789 • Number of events 38 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
8.1%
23/284 • Number of events 29 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
8.5%
10/117 • Number of events 11 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.66%
1/152 • Number of events 1 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
0.00%
0/139 • All solicited and unsolicited Adverse Events (AEs) were collected from Day 1 to 7; serious AEs (SAEs), possibly or probably related, unrelated , medically attended and leading to premature withdrawal AEs were collected during the overall study period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60