Trial Outcomes & Findings for A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years (NCT NCT01339923)

Last Updated: 2016-05-09

Results Overview

Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254 and hSBA titers ≥ 5 against strain M10713 following 2-dose primary series of vaccination with rMenB+OMV NZ at 3.5 and 5 months of age or at 6 and 8 months of age. Analysis was done on Full analysis set (FAS)-Primary series.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1409 participants

Primary outcome timeframe

1 month after second vaccination

Results posted on

2016-05-09

Participant Flow

The study was conducted in a total of a total of 26 sites; 4 sites in Brazil, 3 sites in Peru, 10 sites in Hungary, 9 sites in Spain.

All enrolled subjects were included in the study.

Participant milestones

Participant milestones
Measure	B_2h3h5_11 Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.	B_3h5_11 Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_02_2_5 Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.	B_02_6_10 Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.	BC_35_12 Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.	C_35_12 Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
Overall Study STARTED	253	250	251	104	300	126	125
Overall Study COMPLETED	239	234	243	100	295	117	111
Overall Study NOT COMPLETED	14	16	8	4	5	9	14

Reasons for withdrawal

Reasons for withdrawal
Measure	B_2h3h5_11 Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.	B_3h5_11 Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_02_2_5 Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.	B_02_6_10 Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.	BC_35_12 Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.	C_35_12 Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
Overall Study Adverse Event	1	1	1	0	0	0	1
Overall Study Inappropriate Enrollment	1	0	0	0	0	1	0
Overall Study Lost to Follow-up	4	4	0	3	1	1	5
Overall Study Protocol Violation	0	0	0	0	0	3	1
Overall Study Unable to Classify	1	0	1	0	0	1	5
Overall Study Withdrawal by Subject	7	11	6	1	4	3	2

Baseline Characteristics

A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	B_2h3h5_11 n=253 Participants Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.	B_3h5_11 n=250 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=251 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_02_2_5 n=104 Participants Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.	B_02_6_10 n=300 Participants Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.	BC_35_12 n=126 Participants Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.	C_35_12 n=125 Participants Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.	TOTAL n=1409 Participants Total of all reporting groups
Age, Continuous	2.0 month STANDARD_DEVIATION 0.1 • n=5 Participants	3.0 month STANDARD_DEVIATION 0.1 • n=7 Participants	6.0 month STANDARD_DEVIATION 0.0 • n=5 Participants	47.5 month STANDARD_DEVIATION 13.4 • n=4 Participants	96.9 month STANDARD_DEVIATION 16.8 • n=21 Participants	3.0 month STANDARD_DEVIATION 0.2 • n=10 Participants	3.0 month STANDARD_DEVIATION 0.1 • n=115 Participants	26.6 month STANDARD_DEVIATION 39.3 • n=24 Participants
Sex: Female, Male Female	117 Participants n=5 Participants	124 Participants n=7 Participants	127 Participants n=5 Participants	49 Participants n=4 Participants	149 Participants n=21 Participants	74 Participants n=10 Participants	59 Participants n=115 Participants	699 Participants n=24 Participants
Sex: Female, Male Male	136 Participants n=5 Participants	126 Participants n=7 Participants	124 Participants n=5 Participants	55 Participants n=4 Participants	151 Participants n=21 Participants	52 Participants n=10 Participants	66 Participants n=115 Participants	710 Participants n=24 Participants

PRIMARY outcome

Timeframe: 1 month after second vaccination

Population: FAS-Primary series

Outcome measures

Outcome measures
Measure	B_3h5_11 n=230 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=238 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination. H44/76 (hSBA≥ 4; N=228, 234))	100 Percentages of subjects Interval 97.0 to 100.0	100 Percentages of subjects Interval 97.0 to 100.0	—	—
Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination. 5/99 (hSBA≥ 4)	100 Percentages of subjects Interval 97.0 to 100.0	100 Percentages of subjects Interval 98.0 to 100.0	—	—
Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination. NZ98/254 (hSBA≥ 4; N=230, 233)	98 Percentages of subjects Interval 95.0 to 99.0	99 Percentages of subjects Interval 97.0 to 100.0	—	—
Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination. M10713 (hSBA≥ 5; N=181, 192))	44 Percentages of subjects Interval 35.0 to 52.0	73 Percentages of subjects Interval 65.0 to 80.0	—	—

SECONDARY outcome

Timeframe: 1 month after third vaccination

Population: FAS-primary series

Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713, following 3-dose primary series of vaccination with rMenB+OMV NZ at 2.5, 3.5 and 5 months of age. Analysis was done on FAS-primary series.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=238 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination H44/76 (hSBA≥ 4; 1 month after 3rd vacc; N=237)	100 Percentages of subjects Interval 98.0 to 100.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination 5/99 (hSBA≥ 4; 1 month after 3rd vacc)	100 Percentages of subjects Interval 98.0 to 100.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination NZ98/254 (hSBA≥ 4; 1 month after 3rd vacc)	99 Percentages of subjects Interval 96.0 to 100.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination M10713 (hSBA≥ 5; 1 month after 3rd vacc; N=197)	55 Percentages of subjects Interval 48.0 to 62.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination H44/76 (hSBA≥ 8; 1 month after 3rd vacc; N=237)	98 Percentages of subjects Interval 96.0 to 100.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination 5/99 (hSBA≥ 8; 1 month after 3rd vacc)	100 Percentages of subjects Interval 98.0 to 100.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination NZ98/254 (hSBA≥ 8; 1 month after 3rd vacc)	89 Percentages of subjects Interval 85.0 to 93.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination M10713 (hSBA≥ 8; 1 month after 3rd vacc; N=197)	47 Percentages of subjects Interval 40.0 to 54.0	—	—	—

SECONDARY outcome

Timeframe: 1 month after second vaccination

Population: FAS-primary series

Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following 2-dose catch-up series of vaccination with rMenB+OMV NZ in healthy children aged 2-10 years (0, 2 month schedule). Analysis was done on FAS-primary series.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=390 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination H44/76 (hSBA≥ 4; 1 month after 2nd vacc; N=386)	99 Percentages of subjects Interval 97.0 to 100.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination 5/99 (hSBA≥ 4; 1 month after 2nd vacc)	99 Percentages of subjects Interval 98.0 to 100.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination NZ98/254 (hSBA≥ 4; 1 month after 2nd vacc; N=389)	99 Percentages of subjects Interval 97.0 to 100.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination M10713 (hSBA≥ 5; 1 month after 2nd vacc; N=370)	94 Percentages of subjects Interval 91.0 to 96.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination H44/76 (hSBA≥ 8; 1 month after 2nd vacc; N=386)	98 Percentages of subjects Interval 96.0 to 99.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination 5/99 (hSBA≥ 8; 1 month after 2nd vacc)	99 Percentages of subjects Interval 98.0 to 100.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination NZ98/254 (hSBA≥ 8; 1 month after 2nd vacc; N=389)	95 Percentages of subjects Interval 92.0 to 97.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination M10713 (hSBA≥ 8; 1 month after 2nd vacc; N=370)	92 Percentages of subjects Interval 89.0 to 94.0	—	—	—

SECONDARY outcome

Timeframe: 1 month after second vaccination

Population: FAS- primary series

Immunogenicity was assessed in terms of percentages of subjects achieving 4-fold increase in hSBA titers as compared to baseline against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254, M10713; following 2-dose catch-up series of vaccination with rMenB+OMV NZ in healthy children aged 2-10 years (0, 2 month schedule). Analysis was done on FAS- primary series.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=388 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Percentages of Subjects Achieving Four-fold Rise Over Baseline hSBA Titers Following a 2-dose Catch-up Series of rMenB+OMV Vaccination H44/76 (1 month after 2nd vacc; N=385)	96 Percentages of subjects Interval 93.0 to 97.0	—	—	—
Percentages of Subjects Achieving Four-fold Rise Over Baseline hSBA Titers Following a 2-dose Catch-up Series of rMenB+OMV Vaccination 5/99 (1 month after 2nd vacc)	99 Percentages of subjects Interval 97.0 to 100.0	—	—	—
Percentages of Subjects Achieving Four-fold Rise Over Baseline hSBA Titers Following a 2-dose Catch-up Series of rMenB+OMV Vaccination NZ98/254 (1 month after 2nd vacc; N=387)	93 Percentages of subjects Interval 89.0 to 95.0	—	—	—
Percentages of Subjects Achieving Four-fold Rise Over Baseline hSBA Titers Following a 2-dose Catch-up Series of rMenB+OMV Vaccination M10713 (1 month after 2nd vacc; N=352)	46 Percentages of subjects Interval 41.0 to 51.0	—	—	—

SECONDARY outcome

Timeframe: 1 month after primary series vaccination

Population: FAS-primary series

Immunogenicity was assessed in terms of Geometric mean hSBA titers (GMTs) against N meningitidis serogroup B indicator strains following 2 or 3 dose primary series of vaccination rMenB+OMV NZ (1 month after 3rd infant vaccination in B\_2h3h5\_11 and 1 month after 2nd infant vaccination in B\_3h5\_11, B\_68\_11 and B\_02). Analysis was done on FAS-primary series.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=238 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=230 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=238 Participants Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 n=390 Participants Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV H44/76 (1 month after primary vacc; N=237,228,234,	109 Titers Interval 92.0 to 130.0	132 Titers Interval 110.0 to 158.0	240 Titers Interval 201.0 to 287.0	121 Titers Interval 109.0 to 135.0
Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV 5/99 (1 month after primary vacc)	795 Titers Interval 665.0 to 950.0	605 Titers Interval 502.0 to 729.0	1157 Titers Interval 964.0 to 1390.0	489 Titers Interval 442.0 to 541.0
Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV NZ98/254 1m after primary vacc; N=238,230,233,389	34 Titers Interval 28.0 to 42.0	39 Titers Interval 31.0 to 48.0	65 Titers Interval 52.0 to 80.0	42 Titers Interval 38.0 to 47.0
Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV M10713 1 m after primary vacc; N=197,181,192,370	4.86 Titers Interval 3.62 to 6.54	3.39 Titers Interval 2.48 to 4.64	9.96 Titers Interval 7.33 to 14.0	35 Titers Interval 31.0 to 39.0

SECONDARY outcome

Timeframe: 1, 1.5 or 2 months after first infant vaccination

Population: FAS-post first dose

Immunogenicity was assessed in terms of Geometric mean hSBA titers (GMTs) against N meningitidis serogroup B indicator strains after the first infant vaccination in groups B\_2h3h5\_11b, B\_3h5\_11b and B\_68\_11b (after 1 month for group B\_2h3h5\_11b, 1.5 months for group B\_2h3h5\_11b and 2 months for group B\_68\_11b). Analysis was done on FAS-post first dose.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=119 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=115 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=118 Participants Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV. NZ98/254 1 month after 1st vacc; N=118,114,117	2.87 Titers Interval 2.32 to 3.54	2.48 Titers Interval 1.98 to 3.11	2.84 Titers Interval 2.28 to 3.55	—
Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV. H44/76 1 month after 1st vacc; N=117,115,117	4.19 Titers Interval 3.29 to 5.35	5.7 Titers Interval 4.41 to 7.37	9.83 Titers Interval 7.59 to 13.0	—
Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV. 5/99 1 month after 1st vacc	20 Titers Interval 15.0 to 27.0	30 Titers Interval 22.0 to 42.0	37 Titers Interval 27.0 to 52.0	—
Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV. M10713 1 month after 1st vacc; N=95,99,95	2.59 Titers Interval 1.86 to 3.6	1.69 Titers Interval 1.21 to 2.36	1.62 Titers Interval 1.15 to 2.28	—

SECONDARY outcome

Timeframe: Post- first dose (1 month for B_2h3h5_11b, 1.5 month for B_3h5_11b and 2 months for B_68_11b after 1st vaccination)

Population: FAS-post first dose

Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254, hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713 after the first infant vaccination in groups B\_2h3h5\_11b, B\_3h5\_11b and B\_68\_11b (at 3.5, 5, and 8 months of age respectively). Analysis was done on FAS-post first dose.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=119 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=115 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=118 Participants Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV H44/76 (hSBA≥ 4; Post 1st vacc; N=117,115,117)	62 Percentages of subjects Interval 52.0 to 70.0	72 Percentages of subjects Interval 63.0 to 80.0	82 Percentages of subjects Interval 74.0 to 89.0	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV 5/99 (hSBA≥ 4; Post 1st vacc)	91 Percentages of subjects Interval 84.0 to 95.0	95 Percentages of subjects Interval 89.0 to 98.0	92 Percentages of subjects Interval 86.0 to 96.0	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV NZ98/254 (hSBA≥ 4; Post 1st vacc; N=118,114,117)	43 Percentages of subjects Interval 34.0 to 53.0	39 Percentages of subjects Interval 30.0 to 48.0	41 Percentages of subjects Interval 32.0 to 50.0	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV M10713 (hSBA≥ 5; Post1st vacc; N=95,99,95)	31 Percentages of subjects Interval 21.0 to 41.0	18 Percentages of subjects Interval 11.0 to 27.0	17 Percentages of subjects Interval 10.0 to 26.0	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV H44/76 (hSBA≥ 8; Post 1st vacc; N=117,115,117)	25 Percentages of subjects Interval 17.0 to 34.0	38 Percentages of subjects Interval 29.0 to 48.0	58 Percentages of subjects Interval 49.0 to 67.0	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV 5/99 (hSBA≥ 8; Post1st vacc)	82 Percentages of subjects Interval 73.0 to 88.0	90 Percentages of subjects Interval 82.0 to 94.0	86 Percentages of subjects Interval 79.0 to 92.0	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV NZ98/254 (hSBA≥ 8; 1st vacc; N=118,114,117)	13 Percentages of subjects Interval 7.0 to 20.0	7 Percentages of subjects Interval 3.0 to 13.0	13 Percentages of subjects Interval 7.0 to 20.0	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV M10713 (hSBA≥ 8; Post1st vacc; N=95,99,95)	21 Percentages of subjects Interval 13.0 to 31.0	15 Percentages of subjects Interval 9.0 to 24.0	13 Percentages of subjects Interval 7.0 to 21.0	—

SECONDARY outcome

Timeframe: 1 month post-booster dose

Population: FAS-booster

Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following a booster dose of rMenB+OMV NZ given at 11 months of age (4th dose for B\_2h3h5\_11 and 3rd dose for B\_3h5\_11 and B\_68\_11). Analysis was done on FAS-booster.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=233 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=228 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=239 Participants Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination H44/76 (hSBA≥ 4, after booster; N=233,227,238)	100 Percentages of subjects Interval 98.0 to 100.0	100 Percentages of subjects Interval 98.0 to 100.0	100 Percentages of subjects Interval 98.0 to 100.0	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination 5/99 (hSBA≥ 4, after booster)	100 Percentages of subjects Interval 98.0 to 100.0	100 Percentages of subjects Interval 98.0 to 100.0	100 Percentages of subjects Interval 98.0 to 100.0	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination NZ98/254 (hSBA≥ 4, after booster; N=231,226,236)	100 Percentages of subjects Interval 98.0 to 100.0	99 Percentages of subjects Interval 96.0 to 100.0	100 Percentages of subjects Interval 98.0 to 100.0	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination M10713 (hSBA≥ 5, after booster; N=203,181,193)	83 Percentages of subjects Interval 77.0 to 88.0	87 Percentages of subjects Interval 81.0 to 91.0	83 Percentages of subjects Interval 77.0 to 88.0	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination H44/76 (hSBA≥ 8, after booster; N=233,227,238)	100 Percentages of subjects Interval 98.0 to 100.0	100 Percentages of subjects Interval 98.0 to 100.0	100 Percentages of subjects Interval 98.0 to 100.0	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination 5/99 (hSBA≥ 8, after booster)	100 Percentages of subjects Interval 98.0 to 100.0	100 Percentages of subjects Interval 98.0 to 100.0	100 Percentages of subjects Interval 98.0 to 100.0	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination NZ98/254 (hSBA≥ 8, after booster; N=231,226,236)	95 Percentages of subjects Interval 91.0 to 97.0	95 Percentages of subjects Interval 91.0 to 98.0	97 Percentages of subjects Interval 95.0 to 99.0	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination M10713 (hSBA≥ 8, after booster; N=203,181,193)	78 Percentages of subjects Interval 72.0 to 84.0	83 Percentages of subjects Interval 77.0 to 89.0	74 Percentages of subjects Interval 67.0 to 80.0	—

SECONDARY outcome

Timeframe: 11 months of age (persistence)

Population: FAS-persistence

Persistence of bactericidal antibodies at 11 months of age was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713 in subjects who previously received a primary series of 2 or 3-doses of rMenB+OMV NZ vaccine. Analysis was done on FAS-persistence.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=235 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=233 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=238 Participants Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ H44/76 (hSBA≥ 4; 11 months of age; N=235,232,237)	87 Percentages of subjects Interval 82.0 to 91.0	86 Percentages of subjects Interval 81.0 to 90.0	100 Percentages of subjects Interval 98.0 to 100.0	—
Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ 5/99 (hSBA≥ 4; 11 months of age; N=234,230,235)	100 Percentages of subjects Interval 98.0 to 100.0	93 Percentages of subjects Interval 89.0 to 96.0	100 Percentages of subjects Interval 98.0 to 100.0	—
Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ NZ98/254 hSBA≥ 4; 11 months of age; N=233,233,238)	54 Percentages of subjects Interval 47.0 to 60.0	41 Percentages of subjects Interval 34.0 to 47.0	90 Percentages of subjects Interval 85.0 to 93.0	—
Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ M10713 (hSBA≥ 5; 11 months of age; N=199,177,188)	33 Percentages of subjects Interval 26.0 to 40.0	23 Percentages of subjects Interval 17.0 to 30.0	42 Percentages of subjects Interval 35.0 to 49.0	—
Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ H44/76 (hSBA≥ 8; 11 months of age; N=235,232,237)	64 Percentages of subjects Interval 58.0 to 70.0	60 Percentages of subjects Interval 53.0 to 66.0	96 Percentages of subjects Interval 93.0 to 98.0	—
Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ 5/99 (hSBA≥ 8; 11 months of age; N=234,230,235)	94 Percentages of subjects Interval 91.0 to 97.0	87 Percentages of subjects Interval 82.0 to 91.0	99 Percentages of subjects Interval 97.0 to 100.0	—
Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ NZ98/254 hSBA≥ 8; 11 months of age; N=233,233,238)	36 Percentages of subjects Interval 30.0 to 43.0	12 Percentages of subjects Interval 8.0 to 17.0	65 Percentages of subjects Interval 58.0 to 71.0	—
Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ M10713 (hSBA≥ 8; 11 months of age; N=199,177,188)	24 Percentages of subjects Interval 18.0 to 30.0	16 Percentages of subjects Interval 11.0 to 22.0	36 Percentages of subjects Interval 29.0 to 43.0	—

SECONDARY outcome

Timeframe: 11 months of age (persistence)

Population: FAS-persistence

Persistence of bactericidal antibodies at 11 months of age was assessed in terms of GMTs against N meningitidis serogroup B indicator strains in subjects who previously received a primary series of 2 or 3-doses of rMenB+OMV NZ. Analysis was done on FAS-persistence.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=235 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=233 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=238 Participants Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ H44/76 (Baseline; N=111,113,120)	1.31 Titers Interval 1.09 to 1.57	1.34 Titers Interval 1.11 to 1.62	1.58 Titers Interval 1.32 to 1.9	—
Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ H44/76 (11 moa; N=235,232,237))	12 Titers Interval 9.64 to 14.0	12 Titers Interval 9.39 to 14.0	67 Titers Interval 55.0 to 82.0	—
Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ 5/99 (Baseline; N=113,112,120)	1.15 Titers Interval 1.02 to 1.3	1.16 Titers Interval 1.02 to 1.32	0.97 Titers Interval 0.85 to 1.09	—
Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ 5/99 (11 moa; N=234,230,235)	98 Titers Interval 78.0 to 124.0	50 Titers Interval 39.0 to 63.0	285 Titers Interval 225.0 to 363.0	—
Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ NZ98/254 (Baseline; N=113,113,122)	1.07 Titers Interval 0.99 to 1.15	1.04 Titers Interval 0.96 to 1.12	1 Titers Interval 0.93 to 1.07	—
Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ NZ98/254 (11 moa; N=233,233,238)	4.57 Titers Interval 3.66 to 5.71	2.68 Titers Interval 2.13 to 3.38	12 Titers Interval 9.79 to 15.0	—
Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ M10713 (Baseline; N=84,64,88)	2.36 Titers Interval 1.75 to 3.2	1.52 Titers Interval 1.07 to 2.17	1.29 Titers Interval 0.95 to 1.76	—
Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ M10713 (11 moa; N=199,177,188)	2.55 Titers Interval 1.89 to 3.43	1.98 Titers Interval 1.45 to 2.71	3.62 Titers Interval 2.66 to 4.94	—

SECONDARY outcome

Timeframe: 1 month after primary vaccination, pre-booster vaccination (persistence) and 1 month after booster vaccination

Population: FAS-persistence and FAS-booster

Immunogenicity was assessed in terms of Geometric mean ELISA concentrations (GMCs) against N meningitidis serogroup B vaccine antigen 287-953, following 2 or 3 dose primary series and booster dose of rMenB+OMV NZ. Analysis was done on FAS-persistence and FAS-booster.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=218 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=225 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=221 Participants Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ 1 month after primary vaccination (N=212,215,212)	4688 IU/mL Interval 3884.0 to 5660.0	3152 IU/mL Interval 2594.0 to 3831.0	4682 IU/mL Interval 3850.0 to 5694.0	—
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ Pre-booster vaccination (N=213,220,215)	474 IU/mL Interval 395.0 to 569.0	291 IU/mL Interval 241.0 to 351.0	1270 IU/mL Interval 1052.0 to 1533.0	—
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ 1 month after booster dose	5900 IU/mL Interval 5047.0 to 6898.0	6062 IU/mL Interval 5150.0 to 7135.0	5898 IU/mL Interval 5016.0 to 6934.0	—

SECONDARY outcome

Timeframe: 1 month after second vaccination

Population: FAS-primary series

Immunogenicity was assessed in terms of Geometric mean ELISA concentrations (GMCs) against N meningitidis serogroup B vaccine antigen 287-953, after a two dose catch-up immunization series with rMenB+OMV NZ in children 2-10 years of age. Analysis was done on FAS-primary series.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=389 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 After a Two Dose Catch-up rMenB+OMV NZ Immunization Series in Children 2-10 Years of Age	2333 IU/mL Interval 2124.0 to 2562.0	—	—	—

SECONDARY outcome

Timeframe: Baseline, 1 month after second vaccination and 1 month after booster vaccination

Population: PPS-primary series and PPS-booster.

Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months, as measured by the percentages of subjects achieving hSBA titers ≥ 8 against serogroup C. Analysis was done on PPS-primary series and PPS-booster.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=85 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=72 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Percentages of Subjects With hSBA Titers ≥ 8 Against Serogroup C Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone Serogroup C (1 month after 2nd vacc)	99 Percentages of subjects Interval 94.0 to 100.0	100 Percentages of subjects Interval 95.0 to 100.0	—	—
Percentages of Subjects With hSBA Titers ≥ 8 Against Serogroup C Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone Serogroup C (1 month after booster vacc; N=70,47)	100 Percentages of subjects Interval 95.0 to 100.0	100 Percentages of subjects Interval 92.0 to 100.0	—	—

SECONDARY outcome

Timeframe: 1 month after second vaccination, 1 month after booster vaccination

Population: FAS-primary series and FAS-booster

Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-primary series and FAS-booster.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=102 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=88 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone 1 month after 2nd vacc	568 Titers Interval 461.0 to 701.0	905 Titers Interval 718.0 to 1141.0	—	—
GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone Pre-booster vacc (N=92,75)	36 Titers Interval 28.0 to 47.0	56 Titers Interval 41.0 to 77.0	—	—
GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone 1 month after booster vacc (N=99,92)	1201 Titers Interval 991.0 to 1456.0	1724 Titers Interval 1350.0 to 2201.0	—	—

SECONDARY outcome

Timeframe: Pre-booster vaccination (persistence; 12 months of age)

Population: FAS-persistence

Outcome measures

Outcome measures
Measure	B_3h5_11 n=108 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=93 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone - Persistence	36 Titers Interval 28.0 to 46.0	56 Titers Interval 41.0 to 75.0	—	—

SECONDARY outcome

Timeframe: 1 month after second vaccination and 1 month after booster vaccination

Population: FAS-primary series and FAS-booster

Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and a booster at 12 months. Analysis was done on FAS-primary series and FAS-booster.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=119 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM H44/76 (hSBA≥4; 1 month after 2nd vacc)	97 Percentages of subjects Interval 92.0 to 99.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM H44/76 (hSBA≥4; 1 month after booster vacc; N=114)	100 Percentages of subjects Interval 97.0 to 100.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM 5/99 (hSBA≥4; 1 month after 2nd vacc)	96 Percentages of subjects Interval 90.0 to 99.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM 5/99 (hSBA≥4; 1 month after booster vacc; N=113)	97 Percentages of subjects Interval 92.0 to 99.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM NZ98/254 (hSBA≥4; 1 month after 2nd vacc; N=118)	95 Percentages of subjects Interval 89.0 to 98.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM NZ98/254 (hSBA≥4; 1 mo after booster vacc; N=114)	97 Percentages of subjects Interval 93.0 to 99.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM M10713 (hSBA≥5; 1 month after 2nd vacc; N=98)	68 Percentages of subjects Interval 58.0 to 77.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM M10713 (hSBA≥5; 1 month after booster vacc; N=101)	67 Percentages of subjects Interval 57.0 to 76.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM H44/76 (hSBA≥8; 1 month after 2nd vacc)	97 Percentages of subjects Interval 92.0 to 99.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM H44/76 (hSBA≥8; 1 month after booster vacc; N=114)	99 Percentages of subjects Interval 95.0 to 100.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM 5/99 (hSBA≥8; 1 month after 2nd vacc)	96 Percentages of subjects Interval 90.0 to 99.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM 5/99 (hSBA≥8; 1 month after booster vacc; N=113)	97 Percentages of subjects Interval 92.0 to 99.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM NZ98/254 (hSBA≥8; 1 month after 2nd vacc; N=118)	87 Percentages of subjects Interval 80.0 to 93.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM NZ98/254 (hSBA≥8; 1 mo after booster vacc; N=114)	95 Percentages of subjects Interval 89.0 to 98.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM M10713 (hSBA≥8; 1 month after 2nd vacc; N=98)	60 Percentages of subjects Interval 50.0 to 70.0	—	—	—
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM M10713 (hSBA≥8; 1 month after booster vacc; N=101)	61 Percentages of subjects Interval 51.0 to 71.0	—	—	—

SECONDARY outcome

Timeframe: 1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination

Population: FAS-persistence and FAS-booster

Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence and FAS-booster.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=115 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM H44/76 (1 month after 2nd vacc)	226 Titers Interval 179.0 to 284.0	—	—	—
GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM H44/76 (Pre-booster vacc)	16 Titers Interval 13.0 to 20.0	—	—	—
GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM H44/76 (1 month after booster vacc; N=114)	239 Titers Interval 198.0 to 288.0	—	—	—
GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM 5/99 (1 month after 2nd vacc)	555 Titers Interval 409.0 to 753.0	—	—	—
GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM 5/99 (Pre-booster vacc)	55 Titers Interval 42.0 to 72.0	—	—	—
GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM 5/99 (1 month after booster vacc; N=113)	1623 Titers Interval 1210.0 to 2176.0	—	—	—
GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM NZ98/254 (1 month after 2nd vacc; N=114)	27 Titers Interval 21.0 to 34.0	—	—	—
GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM NZ98/254 (Pre-booster vacc; N=115)	2.63 Titers Interval 2.21 to 3.14	—	—	—
GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM NZ98/254 (1 month after booster vacc; N=114)	68 Titers Interval 54.0 to 86.0	—	—	—
GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM M10713 (1 month after 2nd vacc; N=89)	9.81 Titers Interval 7.06 to 14.0	—	—	—
GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM M10713 (Pre-booster vacc; N=110)	2.2 Titers Interval 1.72 to 2.82	—	—	—
GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM M10713 (1 month after booster vacc; N=101)	11 Titers Interval 7.72 to 15.0	—	—	—

SECONDARY outcome

Timeframe: 1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination

Population: FAS-primary and FAS-booster

Immunogenicity was assessed in terms of Geometric mean ELISA concentrations against N meningitidis serogroup B vaccine antigen 287-953, following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-primary and FAS-booster.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=116 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM 1 month after 2nd vacc	2125 IU/mL Interval 1595.0 to 2830.0	—	—	—
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM Pre-booster vacc (N=111)	194 IU/mL Interval 164.0 to 230.0	—	—	—
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM 1 month after booster vacc (N=113)	4281 IU/mL Interval 3411.0 to 5372.0	—	—	—

SECONDARY outcome

Timeframe: Pre-booster vaccination (persistence; 12 months of age)

Population: FAS-persistence

Immunogenicity was assessed in terms of GMTs against Geometric mean ELISA concentrations against N meningitidis serogroup B vaccine antigen 287-953, following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=115 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM - Persistence	196 IU/mL Interval 166.0 to 231.0	—	—	—

SECONDARY outcome

Timeframe: Within 30 minutes after any vaccination

Population: Solicited safety set.

Safety was assessed in terms of number of subjects who reported immediate reactions within 30 minutes following a 4-dose regimen (2.5, 3.5, 5 and 11 months) or a 3-dose regimen (3.5, 5 and 11 months or 6, 8 and 11 months) of rMenB+OMV NZ. Analysis was done on solicited safety set.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=252 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=249 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=250 Participants Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ Tenderness	13 Number of subjects	9 Number of subjects	9 Number of subjects	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ Erythema	19 Number of subjects	19 Number of subjects	7 Number of subjects	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ Induration	4 Number of subjects	3 Number of subjects	2 Number of subjects	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ Swelling	1 Number of subjects	2 Number of subjects	1 Number of subjects	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ Change in eating habits	0 Number of subjects	2 Number of subjects	1 Number of subjects	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ Sleepiness	1 Number of subjects	2 Number of subjects	3 Number of subjects	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ Unusual crying	4 Number of subjects	3 Number of subjects	4 Number of subjects	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ Vomiting	1 Number of subjects	0 Number of subjects	0 Number of subjects	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ Diarrhea	0 Number of subjects	0 Number of subjects	1 Number of subjects	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ Irritability	1 Number of subjects	2 Number of subjects	1 Number of subjects	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ Rash	0 Number of subjects	1 Number of subjects	1 Number of subjects	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ Fever (≥38°C)	3 Number of subjects	2 Number of subjects	2 Number of subjects	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ Medic. used for pain (N=252,248,250)	0 Number of subjects	0 Number of subjects	0 Number of subjects	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ Medically-attended fever	0 Number of subjects	0 Number of subjects	0 Number of subjects	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ Medic. used to treat high temp. (N=252,248,250)	1 Number of subjects	1 Number of subjects	0 Number of subjects	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ Medic. used to prevent high temp. (N=252,248,250)	0 Number of subjects	0 Number of subjects	0 Number of subjects	—

SECONDARY outcome

Timeframe: Day 1 to day 7 after any vaccination

Population: Solicited safety set

Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination following a 4-dose regimen (2.5, 3.5, 5 and 11 months) or as a 3-dose regimen (3.5, 5 and 11 months or 6, 8 and 11 months) of rMenB+OMV NZ. Analysis was done on solicited safety set.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=247 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=243 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=246 Participants Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ Erythema (N=245,241,244)	164 Number of subjects	156 Number of subjects	157 Number of subjects	—
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ Induration (N=245,241,244)	161 Number of subjects	117 Number of subjects	121 Number of subjects	—
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ Swelling (N=245,241,244)	120 Number of subjects	75 Number of subjects	84 Number of subjects	—
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ Any local (N=245,241,244)	226 Number of subjects	213 Number of subjects	202 Number of subjects	—
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ Tenderness (N=245,241,244)	200 Number of subjects	174 Number of subjects	166 Number of subjects	—
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ Any systemic (N=245,241,244)	238 Number of subjects	236 Number of subjects	233 Number of subjects	—
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ Change in eating habits (N=245,241,244)	141 Number of subjects	112 Number of subjects	121 Number of subjects	—
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ Sleepiness (N=245,241,244)	186 Number of subjects	152 Number of subjects	143 Number of subjects	—
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ Irritability (N=245,241,244)	180 Number of subjects	156 Number of subjects	151 Number of subjects	—
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ Vomiting (N=245,241,244)	65 Number of subjects	39 Number of subjects	55 Number of subjects	—
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ Diarrhea (N=245,241,244)	91 Number of subjects	69 Number of subjects	74 Number of subjects	—
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ Rash (N=245,241,244)	23 Number of subjects	21 Number of subjects	22 Number of subjects	—
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ Unusual Crying (N=245,241,244)	198 Number of subjects	186 Number of subjects	156 Number of subjects	—
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ Fever (≥38°C) (N=245,241,244)	197 Number of subjects	189 Number of subjects	184 Number of subjects	—
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ Medic. used for pain (N=245,241,244)	129 Number of subjects	110 Number of subjects	109 Number of subjects	—
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ Medic. used to prevent high temp. (N=245,241,244)	97 Number of subjects	94 Number of subjects	99 Number of subjects	—
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ Medic. used to treat high temp. (N=245,242,244)	193 Number of subjects	186 Number of subjects	177 Number of subjects	—
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ Medically-attended fever	16 Number of subjects	10 Number of subjects	15 Number of subjects	—

SECONDARY outcome

Timeframe: Within 30 minutes after any vaccination

Population: Solicited safety set

Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination in subjects aged 2 - 10 years who received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Analysis was done on solicited safety set.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=104 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=300 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Pain	6 Number of subjects	17 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Erythema	6 Number of subjects	2 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Induration	1 Number of subjects	3 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Swelling	2 Number of subjects	2 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Chills (N=0,300)	NA Number of subjects Solicited AE not applicable for this age-group.	2 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Change in eating habits (N=104,0)	0 Number of subjects	NA Number of subjects Solicited AE not applicable for this age-group.	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Sleepiness (N=104,0)	0 Number of subjects	NA Number of subjects Solicited AE not applicable for this age-group.	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Irritability (N=104,0)	1 Number of subjects	NA Number of subjects Solicited AE not applicable for this age-group.	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Vomiting (N=104,0)	0 Number of subjects	NA Number of subjects Solicited AE not applicable for this age-group.	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Nausea (N=0,300)	NA Number of subjects Solicited AE not applicable for this age-group.	2 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Malaise (N=0,300)	NA Number of subjects Solicited AE not applicable for this age-group.	4 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Diarrhoea (N=104,0)	0 Number of subjects	NA Number of subjects Solicited AE not applicable for this age-group.	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Headache	0 Number of subjects	1 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Rash	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Arthralgia	0 Number of subjects	1 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Myalgia (N=0,300)	NA Number of subjects Solicited AE not applicable for this age-group.	5 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Fever (≥38°C)	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Medic. used for pain	0 Number of subjects	1 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Medic. used to prevent high temp.	0 Number of subjects	1 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Medic. used to treat high temp	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10 Medically-attended fever	0 Number of subjects	0 Number of subjects	—	—

SECONDARY outcome

Timeframe: Day 1 to day 7 after any vaccination

Population: Solicited safety set

Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination in subjects aged 2- 10 years who received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Analysis was done on solicited safety set.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=102 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=299 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Any Local (N=100,297)	99 Number of subjects	287 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Pain (N=100,297)	98 Number of subjects	287 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Erythema (N=100,297)	58 Number of subjects	179 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Induration (N=100,297)	41 Number of subjects	123 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Swelling (N=100,297)	50 Number of subjects	146 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Any systemic (N=100,297)	78 Number of subjects	205 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Chills (N=0,296)	NA Number of subjects Solicited AE not applicable for this age-group.	45 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Change in eating habits (N=100,0)	35 Number of subjects	NA Number of subjects Solicited AE not applicable for this age-group.	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Sleepiness (N=100,0)	39 Number of subjects	NA Number of subjects Solicited AE not applicable for this age-group.	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Irritability (N=100,0)	49 Number of subjects	NA Number of subjects Solicited AE not applicable for this age-group.	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Malaise (N=0,296)	NA Number of subjects Solicited AE not applicable for this age-group.	114 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Vomiting (N=100,0)	7 Number of subjects	NA Number of subjects Solicited AE not applicable for this age-group.	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Nausea (N=0,296)	NA Number of subjects Solicited AE not applicable for this age-group.	36 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Diarrhea (N=100,0)	12 Number of subjects	NA Number of subjects Solicited AE not applicable for this age-group.	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Headache (N=100,296)	7 Number of subjects	89 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Rash (N=100,296)	9 Number of subjects	20 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Arthralgia (N=100,296)	35 Number of subjects	49 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Myalgia (N=0,296)	NA Number of subjects Solicited AE not applicable for this age-group.	126 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Fever (≥38°C) (N=100,296)	20 Number of subjects	41 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Medic. used for pain (N=100,296)	48 Number of subjects	158 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Medic. used to prevent high temp. (N=100,296)	7 Number of subjects	44 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Medic. used to treat high temp. (N=100,296)	20 Number of subjects	54 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10 Medically-attended fever	0 Number of subjects	7 Number of subjects	—	—

SECONDARY outcome

Timeframe: Within 30 minutes after any vaccination

Population: Solicited safety set

Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on solicited safety set.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=126 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=124 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Tenderness (rMenB+OMV NZ) (N=126,0)	7 Number of subjects	NA Number of subjects Subjects in this group did not receive rMenB+OMV NZ vaccination.	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Erythema (rMenB+OMV NZ) (N=126,0)	3 Number of subjects	NA Number of subjects Subjects in this group did not receive rMenB+OMV NZ vaccination.	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Induration (rMenB+OMV NZ) (N=126,0)	1 Number of subjects	NA Number of subjects Subjects in this group did not receive rMenB+OMV NZ vaccination.	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Swelling (rMenB+OMV NZ) (N=126,0)	0 Number of subjects	NA Number of subjects Subjects in this group did not receive rMenB+OMV NZ vaccination.	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Tenderness (MenC-CRM)	5 Number of subjects	5 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Erythema (MenC-CRM)	4 Number of subjects	5 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Induration (MenC-CRM)	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Swelling (MenC-CRM)	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Change in eating habits	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Sleepiness	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Unusual crying	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Irritability	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Vomiting	1 Number of subjects	0 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Diarrhea	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Rash	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Fever (≥38°C)	1 Number of subjects	0 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Medic. used for pain	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Medic. used to prevent high temp.	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Medic. used to treat high temp.	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination Medically-attended fever	0 Number of subjects	0 Number of subjects	—	—

SECONDARY outcome

Timeframe: Day 1 to day 7 after any vaccination

Population: Solicited safety set

Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on solicited safety set.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=124 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=117 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Medic. used to treat high temp.	90 Number of subjects	40 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Medically-attended fever	7 Number of subjects	12 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Any local rMenB + OMZ NV	107 Number of subjects	NA Number of subjects Subjects in this group did not receive rMenB+OMV NZ vaccination.	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Any local MenC-CRM	104 Number of subjects	79 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Any systemic	123 Number of subjects	106 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Tenderness (rMenB+OMV NZ) (N=123,0)	105 Number of subjects	NA Number of subjects Subjects in this group did not receive rMenB+OMV NZ vaccination.	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Erythema (rMenB+OMV NZ) (N=123,0)	48 Number of subjects	NA Number of subjects Subjects in this group did not receive rMenB+OMV NZ vaccination.	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Induration (rMenB+OMV NZ) (N=123,0)	37 Number of subjects	NA Number of subjects Subjects in this group did not receive rMenB+OMV NZ vaccination.	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Swelling (rMenB+OMV NZ) (N=123,0)	21 Number of subjects	NA Number of subjects Subjects in this group did not receive rMenB+OMV NZ vaccination.	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Tenderness (MenC-CRM) (N=123,117)	104 Number of subjects	74 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Erythema (MenC-CRM) (N=123,117)	25 Number of subjects	24 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Induration (MenC-CRM) (N=123,117)	10 Number of subjects	26 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Swelling (MenC-CRM) (N=123,117)	12 Number of subjects	21 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Change in eating habits (N=123,117)	67 Number of subjects	47 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Sleepiness (N=123,117)	93 Number of subjects	78 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Unusual crying (N=123,117)	105 Number of subjects	87 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Irritability (N=123,117)	95 Number of subjects	66 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Vomiting (N=123,117)	29 Number of subjects	27 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Diarrhea (N=123,117)	41 Number of subjects	40 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Rash (N=123,117)	8 Number of subjects	4 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Fever (≥38°C) (N=123,117)	97 Number of subjects	45 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Medic. used for pain (N=123,117)	102 Number of subjects	69 Number of subjects	—	—
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination Medic. used to prevent high temp.	49 Number of subjects	25 Number of subjects	—	—

SECONDARY outcome

Timeframe: Until 12 months of age; Day 1 to day 7 (All AEs)

Population: Unsolicited safety set

Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV. Analysis was done on unsolicited safety set.

Outcome measures

Outcome measures
Measure	B_3h5_11 n=252 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=249 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=250 Participants Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 All AEs (days 1-7)	200 Number of subjects	186 Number of subjects	196 Number of subjects	—
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 At least possible related AEs	88 Number of subjects	41 Number of subjects	62 Number of subjects	—
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 SAEs	15 Number of subjects	18 Number of subjects	9 Number of subjects	—
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 At least possibly related SAEs	1 Number of subjects	1 Number of subjects	1 Number of subjects	—
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 Medically attended AEs	178 Number of subjects	179 Number of subjects	182 Number of subjects	—
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 AEs leading to premature withdrawal	1 Number of subjects	1 Number of subjects	0 Number of subjects	—
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11 Deaths	0 Number of subjects	0 Number of subjects	0 Number of subjects	—

SECONDARY outcome

Timeframe: Day 1 to day 7 (All AEs). Throughout the study period (SAEs, medically attended or leading to premature withdrawal AEs)

Population: Unsolicited safety set

Outcome measures

Outcome measures
Measure	B_3h5_11 n=104 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=300 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 All AEs (days 1-7)	58 Number of subjects	101 Number of subjects	—	—
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 At least possible related AEs	16 Number of subjects	24 Number of subjects	—	—
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 SAEs	1 Number of subjects	2 Number of subjects	—	—
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 At least possibly related SAEs	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 Medically attended AEs	42 Number of subjects	74 Number of subjects	—	—
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 AEs leading to premature withdrawal	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10 Deaths	0 Number of subjects	0 Number of subjects	—	—

SECONDARY outcome

Timeframe: Day 1 to Day 301 for BC_35_12 and C_35_12, Day 302 to Day 391 for C_35_12; Day 1 to day 7 (All AEs)

Population: Unsolicited safety set

Outcome measures

Outcome measures
Measure	B_3h5_11 n=126 Participants Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=123 Participants Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_68_11 Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)	B_02 Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. rMenB + OMV NZ vaccine: 2 doses 2 months apart
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 All AEs (days 1-7)	103 Number of subjects	90 Number of subjects	—	—
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 At least possibly related AEs	14 Number of subjects	12 Number of subjects	—	—
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 SAEs	5 Number of subjects	7 Number of subjects	—	—
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 At least possibly related SAEs	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 Medically attended AEs	99 Number of subjects	85 Number of subjects	—	—
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 AEs leading to premature withdrawal	0 Number of subjects	0 Number of subjects	—	—
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12 Deaths	0 Number of subjects	0 Number of subjects	—	—

Adverse Events

B_2h3h5_11

Serious events: 15 serious events

Other events: 246 other events

Deaths: 0 deaths

B_3h5_11

Serious events: 18 serious events

Other events: 240 other events

Deaths: 0 deaths

B_68_11

Serious events: 9 serious events

Other events: 245 other events

Deaths: 0 deaths

B_02_2_5

Serious events: 1 serious events

Other events: 100 other events

Deaths: 0 deaths

B_02_6_10

Serious events: 2 serious events

Other events: 288 other events

Deaths: 0 deaths

BC_35_12

Serious events: 5 serious events

Other events: 124 other events

Deaths: 0 deaths

C_35_12

Serious events: 8 serious events

Other events: 115 other events

Deaths: 0 deaths

TOTAL

Serious events: 58 serious events

Other events: 1358 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	B_2h3h5_11 n=252 participants at risk Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.	B_3h5_11 n=249 participants at risk Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=250 participants at risk Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_02_2_5 n=104 participants at risk Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.	B_02_6_10 n=300 participants at risk Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.	BC_35_12 n=126 participants at risk Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.	C_35_12 n=123 participants at risk Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.	TOTAL n=1404 participants at risk All subjects in the safety population.
Gastrointestinal disorders INGUINAL HERNIA	0.40% 1/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Gastrointestinal disorders VOMITING	0.40% 1/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.14% 2/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.80% 2/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.14% 2/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Blood and lymphatic system disorders LYMPHADENOPATHY	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Congenital, familial and genetic disorders CONGENITAL CENTRAL NERVOUS SYSTEM ANOMALY	0.40% 1/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Eye disorders GLAUCOMA	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.81% 1/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Gastrointestinal disorders ALLERGIC COLITIS	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Gastrointestinal disorders DIARRHOEA	0.40% 1/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.14% 2/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Gastrointestinal disorders FOOD POISONING	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.33% 1/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
General disorders PYREXIA	0.79% 2/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.80% 2/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.36% 5/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations ATYPICAL PNEUMONIA	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.79% 1/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations BRONCHIOLITIS	0.40% 1/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.80% 2/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.2% 3/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.6% 2/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.81% 1/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.64% 9/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations BRONCHITIS	0.79% 2/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.80% 2/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.36% 5/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations BRONCHOPNEUMONIA	0.40% 1/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.4% 3/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.36% 5/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations EAR INFECTION	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations GASTROENTERITIS	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.6% 4/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.80% 2/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.43% 6/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations GASTROENTERITIS ROTAVIRUS	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.79% 1/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.81% 1/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.14% 2/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations GASTROENTERITIS SALMONELLA	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations LARYNGITIS	0.79% 2/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.21% 3/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations MASTOIDITIS	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations NASOPHARYNGITIS	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.79% 1/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations ORAL CANDIDIASIS	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations PNEUMONIA	0.40% 1/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.80% 2/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.6% 2/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.43% 6/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations PYELONEPHRITIS	0.40% 1/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS	0.79% 2/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.14% 2/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations RESPIRATORY TRACT INFECTION VIRAL	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations SALMONELLOSIS	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations URINARY TRACT INFECTION	0.40% 1/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.81% 1/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.21% 3/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Injury, poisoning and procedural complications CONCUSSION	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.33% 1/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Injury, poisoning and procedural complications CONTUSION	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.33% 1/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Injury, poisoning and procedural complications FALL	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.33% 1/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Injury, poisoning and procedural complications SKULL FRACTURE	0.40% 1/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Metabolism and nutrition disorders COW'S MILK INTOLERANCE	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Metabolism and nutrition disorders DEHYDRATION	0.40% 1/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.2% 3/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.81% 1/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.36% 5/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Musculoskeletal and connective tissue disorders JUVENILE IDIOPATHIC ARTHRITIS	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.40% 1/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Nervous system disorders BENIGN INTRACRANIAL HYPERTENSION	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.33% 1/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Nervous system disorders FEBRILE CONVULSION	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.81% 1/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Nervous system disorders GENERALISED TONIC-CLONIC SEIZURE	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.81% 1/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Renal and urinary disorders HYDRONEPHROSIS	0.40% 1/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Respiratory, thoracic and mediastinal disorders ADENOIDAL HYPERTROPHY	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.96% 1/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Respiratory, thoracic and mediastinal disorders BRONCHOSPASM	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.80% 2/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.81% 1/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.21% 3/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Respiratory, thoracic and mediastinal disorders CHOKING	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Respiratory, thoracic and mediastinal disorders SLEEP APNOEA SYNDROME	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.96% 1/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Respiratory, thoracic and mediastinal disorders TONSILLAR HYPERTROPHY	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.96% 1/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.07% 1/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Respiratory, thoracic and mediastinal disorders WHEEZING	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.79% 1/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.14% 2/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.

Other adverse events

Other adverse events
Measure	B_2h3h5_11 n=252 participants at risk Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.	B_3h5_11 n=249 participants at risk Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.	B_68_11 n=250 participants at risk Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.	B_02_2_5 n=104 participants at risk Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.	B_02_6_10 n=300 participants at risk Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.	BC_35_12 n=126 participants at risk Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.	C_35_12 n=123 participants at risk Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.	TOTAL n=1404 participants at risk All subjects in the safety population.
Gastrointestinal disorders DIARRHOEA	38.1% 96/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	29.7% 74/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	30.4% 76/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	11.5% 12/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.7% 5/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	32.5% 41/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	39.8% 49/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	25.1% 353/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
General disorders CHILLS	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	15.7% 47/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	3.3% 47/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Gastrointestinal disorders NAUSEA	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	12.7% 38/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.7% 38/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Gastrointestinal disorders VOMITING	27.4% 69/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	18.5% 46/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	23.2% 58/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	7.7% 8/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.0% 6/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	23.8% 30/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	25.2% 31/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	17.7% 248/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
General disorders CRYING	78.6% 198/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	74.7% 186/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	62.8% 157/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	83.3% 105/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	75.6% 93/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	52.6% 739/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
General disorders INDURATION	23.0% 58/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	9.2% 23/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	10.8% 27/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	6.7% 7/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.0% 6/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.79% 1/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.81% 1/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	8.8% 123/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
General disorders INJECTION SITE ERYTHEMA	67.1% 169/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	64.3% 160/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	62.8% 157/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	56.7% 59/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	60.0% 180/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	49.2% 62/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	33.3% 41/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	59.0% 828/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
General disorders INJECTION SITE INDURATION	64.3% 162/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	47.4% 118/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	48.8% 122/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	39.4% 41/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	41.3% 124/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	33.3% 42/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	33.3% 41/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	46.3% 650/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
General disorders INJECTION SITE PAIN	80.2% 202/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	70.3% 175/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	67.2% 168/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	95.2% 99/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	95.7% 287/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	90.5% 114/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	82.9% 102/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	81.7% 1147/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
General disorders INJECTION SITE SWELLING	47.6% 120/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	30.5% 76/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	33.6% 84/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	48.1% 50/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	48.7% 146/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	27.0% 34/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	28.5% 35/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	38.8% 545/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
General disorders MALAISE	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	39.0% 117/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	8.3% 117/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
General disorders PYREXIA	79.8% 201/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	77.1% 192/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	75.6% 189/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	21.2% 22/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	15.7% 47/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	78.6% 99/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	62.6% 77/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	58.9% 827/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
General disorders SWELLING	10.3% 26/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.4% 6/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	7.6% 19/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	5.8% 6/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.3% 4/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	4.3% 61/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations BRONCHIOLITIS	7.1% 18/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	10.4% 26/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	5.2% 13/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	4.8% 6/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	4.1% 5/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	4.8% 68/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations BRONCHITIS	14.7% 37/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	14.5% 36/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	13.2% 33/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	5.8% 6/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.3% 7/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.4% 3/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	8.7% 122/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations BRONCHOPNEUMONIA	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.80% 2/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.40% 1/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	4.8% 6/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	7.3% 9/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.3% 18/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations CONJUNCTIVITIS	10.7% 27/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	6.0% 15/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	6.8% 17/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.33% 1/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.6% 2/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.4% 3/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	4.6% 65/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations EAR INFECTION	4.8% 12/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	3.6% 9/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	6.4% 16/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.9% 3/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.79% 1/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	4.1% 5/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	3.3% 46/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations GASTROENTERITIS	9.9% 25/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	9.2% 23/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	12.8% 32/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.96% 1/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.0% 3/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	4.0% 5/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	4.9% 6/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	6.8% 95/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations INFLUENZA	2.8% 7/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.6% 4/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.0% 5/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.0% 3/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	5.6% 7/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.6% 2/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.0% 28/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations LARYNGITIS	4.8% 12/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.0% 5/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	6.0% 15/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.4% 3/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.5% 35/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations NASOPHARYNGITIS	15.1% 38/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	12.4% 31/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	18.8% 47/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	4.8% 5/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.7% 5/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	11.1% 14/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	8.9% 11/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	10.8% 151/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations OTITIS MEDIA	2.8% 7/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.6% 4/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	5.6% 14/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.96% 1/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.67% 2/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.0% 28/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations OTITIS MEDIA ACUTE	4.0% 10/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	3.2% 8/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	5.6% 14/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.96% 1/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	9.5% 12/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	13.0% 16/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	4.3% 61/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations PHARYNGITIS	4.4% 11/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	4.0% 10/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	5.6% 14/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.9% 2/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.3% 4/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	4.8% 6/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	8.1% 10/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	4.1% 57/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations RESPIRATORY TRACT INFECTION	7.1% 18/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	5.6% 14/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	11.2% 28/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.4% 3/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.4% 3/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	4.7% 66/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations TONSILLITIS	2.4% 6/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.2% 3/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.8% 7/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.96% 1/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.67% 2/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	4.8% 6/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	9.8% 12/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.6% 37/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	19.4% 49/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	22.5% 56/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	21.6% 54/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.9% 3/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.0% 6/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	46.8% 59/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	48.8% 60/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	20.4% 287/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Infections and infestations VIRAL INFECTION	6.3% 16/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	10.4% 26/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	5.6% 14/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	3.8% 4/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.3% 4/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	8.7% 11/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	8.1% 10/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	6.1% 85/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	33.7% 35/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	16.7% 50/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	6.1% 85/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	42.3% 127/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	9.0% 127/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Nervous system disorders HEADACHE	0.00% 0/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	6.7% 7/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	30.0% 90/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	6.9% 97/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Nervous system disorders SOMNOLENCE	73.8% 186/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	61.0% 152/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	57.6% 144/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	37.5% 39/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	73.8% 93/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	68.3% 84/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	49.7% 698/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Psychiatric disorders EATING DISORDER	56.0% 141/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	45.0% 112/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	48.4% 121/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	33.7% 35/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	53.2% 67/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	52.0% 64/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	38.5% 540/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Psychiatric disorders IRRITABILITY	71.8% 181/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	62.7% 156/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	61.2% 153/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	47.1% 49/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.33% 1/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	75.4% 95/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	64.2% 79/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	50.9% 714/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Respiratory, thoracic and mediastinal disorders BRONCHOSPASM	1.2% 3/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.0% 5/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.2% 3/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	6.3% 8/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	5.7% 7/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.9% 26/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Respiratory, thoracic and mediastinal disorders CATARRH	3.2% 8/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	5.6% 14/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	5.6% 14/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.67% 2/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.7% 38/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Respiratory, thoracic and mediastinal disorders COUGH	4.8% 12/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.4% 6/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	5.2% 13/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.9% 3/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.7% 5/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.79% 1/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.81% 1/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	2.9% 41/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Skin and subcutaneous tissue disorders ERYTHEMA	7.9% 20/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	3.2% 8/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	4.8% 12/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	5.8% 6/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.0% 3/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	1.6% 2/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	0.00% 0/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	3.6% 51/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.
Skin and subcutaneous tissue disorders RASH	14.3% 36/252 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	11.2% 28/249 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	12.8% 32/250 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	8.7% 9/104 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	7.0% 21/300 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	8.7% 11/126 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	4.9% 6/123 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.	10.2% 143/1404 • Till 12 months of age for groups B_2h3h5_11, B_3h5_11 and B_68_11; Day 1 to Day 91 for groups B02_2_5 and B02_6_10; Day 1 to Day 301 for group BC_35_12; Day 1 to Day 391 for group C_35_12. All solicited AEs were collected by systematic assessment and unsolicited AEs were collected by non-systematic assessment.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER