Trial Outcomes & Findings for Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers (NCT NCT00667602)

Last Updated: 2013-11-07

Results Overview

Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was measured using serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 against N.meningitidis serogroup C.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

662 participants

Primary outcome timeframe

1 month postvaccination

Results posted on

2013-11-07

Participant Flow

All participants enrolled were included in the trial.

Participant milestones

Participant milestones
Measure	MenACWY-CRM197 (2dose) + Concomitant Vaccines Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenACWY-CRM197 (1dose) + Concomitant Vaccines Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Overall Study STARTED	219	228	215
Overall Study COMPLETED	211	213	197
Overall Study NOT COMPLETED	8	15	18

Reasons for withdrawal

Reasons for withdrawal
Measure	MenACWY-CRM197 (2dose) + Concomitant Vaccines Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenACWY-CRM197 (1dose) + Concomitant Vaccines Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Overall Study Withdrawal by Subject	4	9	10
Overall Study Lost to Follow-up	4	5	6
Overall Study Administrative reason	0	0	2
Overall Study Protocol Violation	0	1	0

Baseline Characteristics

Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MenACWY-CRM197 (2dose) + Concomitant Vaccines n=219 Participants Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=228 Participants Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=215 Participants Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	Total n=662 Participants Total of all reporting groups
Age Continuous	208.4 Days STANDARD_DEVIATION 23.7 • n=5 Participants	209.8 Days STANDARD_DEVIATION 22.2 • n=7 Participants	209.3 Days STANDARD_DEVIATION 21.9 • n=5 Participants	209.2 Days STANDARD_DEVIATION 22.6 • n=4 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	106 Participants n=7 Participants	94 Participants n=5 Participants	305 Participants n=4 Participants
Sex: Female, Male Male	114 Participants n=5 Participants	122 Participants n=7 Participants	121 Participants n=5 Participants	357 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 month postvaccination

Population: Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.

Outcome measures

Outcome measures
Measure	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=175 Participants Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=153 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C	83 Percentages of subjects Interval 77.0 to 89.0	92 Percentages of subjects Interval 86.0 to 95.0	—

SECONDARY outcome

Timeframe: 1 month postvaccination

Population: Analysis was done on PP set.

Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentage of subjects with serum bactericidal activity using human complement (hSBA) titers ≥ 1:4 against N. meningitidis serogroup C.

Outcome measures

Outcome measures
Measure	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=175 Participants Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=153 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C	90 Percentages of subjects Interval 85.0 to 94.0	97 Percentages of subjects Interval 93.0 to 99.0	—

SECONDARY outcome

Timeframe: 1 month postvaccination.

Population: Analysis was done on PP set.

1. Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month postvaccination was assessed and compared as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup C. 2. Immunogenicity of two doses of MenACWY-CRM197 vaccine one month postvaccination was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup A, W, Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=167 Participants Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=153 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y titer ≥ 1:8, prevacc, Men A, (N=159,23)	21 Percentages of subjects Interval 15.0 to 29.0	0 Percentages of subjects Interval 0.0 to 15.0	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y titer ≥ 1:8, postvacc, Men A (N=166,23)	93 Percentages of subjects Interval 88.0 to 97.0	0 Percentages of subjects Interval 0.0 to 15.0	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y titer ≥ 1:8, prevacc, Men C (N=161,152)	78 Percentages of subjects Interval 71.0 to 84.0	6 Percentages of subjects Interval 3.0 to 11.0	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y titer ≥ 1:8, postvacc, Men C (N=167,153)	99 Percentages of subjects Interval 96.0 to 100.0	92 Percentages of subjects Interval 86.0 to 95.0	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y titer ≥ 1:8, prevacc, Men W, (N=157,23)	68 Percentages of subjects Interval 60.0 to 75.0	0 Percentages of subjects Interval 0.0 to 15.0	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y titer ≥ 1:8, postvacc, Men W, (N=165,22)	98 Percentages of subjects Interval 94.0 to 99.0	5 Percentages of subjects Interval 0.0 to 23.0	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y titer ≥ 1:8, prevacc, Men Y, (N=156, 23)	69 Percentages of subjects Interval 61.0 to 76.0	0 Percentages of subjects Interval 0.0 to 15.0	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y titer ≥ 1:8, postvacc, Men Y, (N=163,22)	96 Percentages of subjects Interval 91.0 to 98.0	5 Percentages of subjects Interval 0.0 to 23.0	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y titer ≥ 1:4, prevacc, Men A, (N=159,23)	26 Percentages of subjects Interval 19.0 to 33.0	0 Percentages of subjects Interval 0.0 to 15.0	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y titer ≥ 1:4, postvacc, Men A, (N=166,23)	95 Percentages of subjects Interval 91.0 to 98.0	0 Percentages of subjects Interval 0.0 to 15.0	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y titer ≥ 1:4, prevacc, Men C, (N=161,152)	88 Percentages of subjects Interval 81.0 to 92.0	7 Percentages of subjects Interval 4.0 to 13.0	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y titer ≥ 1:4, postvacc, Men C, (N=167,153)	99 Percentages of subjects Interval 96.0 to 100.0	97 Percentages of subjects Interval 93.0 to 99.0	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y titer ≥ 1:4, prevacc, Men W, (N=157,23)	74 Percentages of subjects Interval 66.0 to 81.0	0 Percentages of subjects Interval 0.0 to 15.0	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y titer ≥ 1:4, postvacc, Men W, (N=165,22)	98 Percentages of subjects Interval 94.0 to 99.0	5 Percentages of subjects Interval 0.0 to 23.0	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y titer ≥ 1:4, prevacc, Men Y, (N=156,23)	78 Percentages of subjects Interval 71.0 to 84.0	0 Percentages of subjects Interval 0.0 to 15.0	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y titer ≥ 1:4, postvacc, Men Y, (N=163,22)	99 Percentages of subjects Interval 96.0 to 100.0	5 Percentages of subjects Interval 0.0 to 23.0	—

SECONDARY outcome

Timeframe: 1 month postvaccination.

Population: Analysis was done on PP set.

Immunogenicity for one dose of MenACWY was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8 and titer ≥ 1:4 by serogroups A, W, Y. Serogroup C is not shown here as it is shown in other outcome measures.

Outcome measures

Outcome measures
Measure	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=175 Participants Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y titer ≥ 1:8, pre-vacc, Men A, (N=171)	1 Percentages of subjects Interval 0.015 to 3.0	—	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y titer ≥ 1:8, post-vacc, Men A, (N=172)	49 Percentages of subjects Interval 41.0 to 57.0	—	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y titer ≥ 1:8, pre-vacc, Men W, (N=168)	3 Percentages of subjects Interval 1.0 to 7.0	—	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y titer ≥ 1:8, post-vacc, Men W, (N=170)	61 Percentages of subjects Interval 53.0 to 68.0	—	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y titer ≥ 1:8, pre-vacc, Men Y, (N=160)	3 Percentages of subjects Interval 1.0 to 6.0	—	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y titer ≥ 1:8, post-vacc, Men Y, (N=167)	50 Percentages of subjects Interval 42.0 to 58.0	—	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y titer ≥ 1:4, pre-vacc, Men A, (N=171)	1 Percentages of subjects Interval 0.015 to 3.0	—	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y titer ≥ 1:4, post-vacc, Men A, (N=172)	58 Percentages of subjects Interval 50.0 to 65.0	—	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y titer ≥ 1:4, pre-vacc, Men W, (N=168)	4 Percentages of subjects Interval 1.0 to 8.0	—	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y titer ≥ 1:4, post-vacc, Men W, (N=170)	62 Percentages of subjects Interval 55.0 to 70.0	—	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y titer ≥ 1:4, pre-vacc, Men Y, (N=160)	3 Percentages of subjects Interval 1.0 to 6.0	—	—
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y titer ≥ 1:4, post-vacc, Men Y, (N=167)	56 Percentages of subjects Interval 48.0 to 63.0	—	—

SECONDARY outcome

Timeframe: 1 month postvaccination

Population: Analysis was done on PP set.

Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed with geometric mean titer (GMT) of serum bactericidal assay with human complement (hSBA) against N. meningitidis serogroup C.

Outcome measures

Outcome measures
Measure	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=175 Participants Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=153 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C Prevaccination (month 12) (N=174, 152)	2.11 Titers Interval 1.77 to 2.51	2.29 Titers Interval 1.9 to 2.75	—
Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C Postvaccination (month 13) (N=175,153)	22 Titers Interval 18.0 to 28.0	31 Titers Interval 24.0 to 39.0	—

SECONDARY outcome

Timeframe: 1 month postvaccination

Population: Analysis was done on PP set.

Immunogenicity of one dose of MenACWY-CRM197 one month postvaccination was assessed with GMT of serum bactericidal assay with hSBA against Serogroups A, W, Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=172 Participants Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y prevacc, Men A (N=171)	1.99 Titers Interval 1.72 to 2.3	—	—
Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y postvacc Men A (N=172)	10 Titers Interval 7.71 to 13.0	—	—
Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y prevacc, Men W (N=168)	2.12 Titers Interval 1.71 to 2.62	—	—
Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y postvacc Men W (N=170)	14 Titers Interval 10.0 to 19.0	—	—
Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y prevacc, Men Y (N=160)	1.92 Titers Interval 1.59 to 2.32	—	—
Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y postvacc Men Y (N=167)	7.05 Titers Interval 5.43 to 9.15	—	—

SECONDARY outcome

Timeframe: 1 month postvaccination

Population: Analysis was done on PP set.

1. The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed and compared as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroup C. 2. The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroups A, W, Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=167 Participants Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=153 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y prevacc, Men A (N=159,23)	3.4 Titers Interval 2.92 to 3.97	2 Titers Interval 1.46 to 2.73	—
Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y postvacc Men A (N=166,23)	75 Titers Interval 56.0 to 99.0	2.22 Titers Interval 1.22 to 4.04	—
Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y prevacc, Men C (N=161,152)	23 Titers Interval 19.0 to 28.0	2.29 Titers Interval 1.9 to 2.75	—
Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y postvacc, Men C (N=167,153)	249 Titers Interval 197.0 to 314.0	31 Titers Interval 24.0 to 39.0	—
Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y prevacc, Men W (N=157,23)	14 Titers Interval 11.0 to 17.0	1.71 Titers Interval 1.06 to 2.74	—
Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y postvacc, Men W (N=165,22)	213 Titers Interval 153.0 to 295.0	2 Titers Interval 0.99 to 4.03	—
Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y prevacc, Men Y (N=156,23)	11 Titers Interval 9.44 to 14.0	1.76 Titers Interval 1.18 to 2.63	—
Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y postvacc, Men Y (N=163,22)	156 Titers Interval 119.0 to 205.0	1.93 Titers Interval 1.06 to 3.52	—

SECONDARY outcome

Timeframe: 1 month postvaccination

Population: Analysis was done on PP set.

The immunogenicity of one dose of MenC to one dose of DTPa-IPV-HepB-Hib concomitant vacccine was assessed. For Pertussis antigens, Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN), the seroresponse in initially seronegative subjects (pre-vaccination antibody concentration \< LLQ) is defined as post-vaccination antibody concentration \>= LLQ; in initially seropositive subjects (pre-vaccination antibody concentration \>=LLQ) seroresponse is defined as at least two fold increase of the pre-vaccination antibody concentration. Diptheria and Tetanus: primary endpoint ELISA (Enzyme-linked immunosorbent assay) \>=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA\>=1.0 IU/mL. Polio type 1, 2 and 3: bNT (neutralization test) with \>=1:8. HepB (HBV): primary endpoint ELISA \>=10mU/mL. PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL.

Outcome measures

Outcome measures
Measure	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=168 Participants Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=173 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=152 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine) Anti-Diphtheria Toxin ≥ 0.1 IU/mL N= (168,173,152)	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 Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine) Anti-Diphtheria Toxin ≥ 1.0 IU/mL N= (168,173,152)	99 Percentages of subjects Interval 96.0 to 100.0	98 Percentages of subjects Interval 95.0 to 100.0	98 Percentages of subjects Interval 94.0 to 100.0
Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine) Anti-Tetanus Toxin ≥ 0.1 IU/mL N= (168,173,152)	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 Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine) Anti-Tetanus Toxin ≥ 1.0 IU/mL N= (168,173,152)	96 Percentages of subjects Interval 92.0 to 98.0	96 Percentages of subjects Interval 92.0 to 98.0	97 Percentages of subjects Interval 93.0 to 99.0
Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine) FHA ELISA N=(160,169,152)	97 Percentages of subjects Interval 93.0 to 99.0	91 Percentages of subjects Interval 86.0 to 95.0	96 Percentages of subjects Interval 92.0 to 99.0
Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine) PRN ELISA N=(160,169,152)	99 Percentages of subjects Interval 97.0 to 100.0	98 Percentages of subjects Interval 94.0 to 99.0	99 Percentages of subjects Interval 95.0 to 100.0
Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine) PT ELISA N=(159,165,151)	97 Percentages of subjects Interval 93.0 to 99.0	95 Percentages of subjects Interval 90.0 to 97.0	97 Percentages of subjects Interval 92.0 to 99.0
Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine) polio 1 N=(157,161,148)	100 Percentages of subjects Interval 98.0 to 100.0	100 Percentages of subjects Interval 98.0 to 100.0	99 Percentages of subjects Interval 96.0 to 100.0
Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine) polio 2 N=157,(161,148)	100 Percentages of subjects Interval 98.0 to 100.0	99 Percentages of subjects Interval 97.0 to 100.0	100 Percentages of subjects Interval 98.0 to 100.0
Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine) polio 3 N=(146,151,143)	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 97.0 to 100.0
Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine) Hep B N=(157,161,147)	99 Percentages of subjects Interval 97.0 to 100.0	99 Percentages of subjects Interval 96.0 to 100.0	99 Percentages of subjects Interval 96.0 to 100.0
Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine) Anti-PRP (HIB) ≥ 0.15 μg/mL N=(168,173,151)	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 Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine) Anti-PRP (HIB) ≥ 1.0 μg/mL N=(168,173,151)	100 Percentages of subjects Interval 98.0 to 100.0	98 Percentages of subjects Interval 95.0 to 100.0	99 Percentages of subjects Interval 96.0 to 100.0

SECONDARY outcome

Timeframe: 1 month postvaccination

Population: Analysis was done on PP set.

To compare the immunogenicity of PCV7 (Pneumococcal 7-valent Conjugate)Vaccine when given concomitantly with one dose or two doses of MenACWY-CRM197 or with MenC to infants at 12 months of age. Seroresponse for PCV7 (PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F, PnC 23F) is defined as: a subject with primary endpoint ELISA ≥ 0.35 mcg/mL and secondary endpoint ELISA ≥ 1.0 mcg/mL.

Outcome measures

Outcome measures
Measure	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=163 Participants Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=168 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=150 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine) PNC 4 N=(168,150)	83 Percentages of subjects Interval 76.0 to 88.0	82 Percentages of subjects Interval 75.0 to 88.0	87 Percentages of subjects Interval 81.0 to 92.0
Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine) PNC 6B N=(168,149)	92 Percentages of subjects Interval 87.0 to 96.0	91 Percentages of subjects Interval 86.0 to 95.0	97 Percentages of subjects Interval 93.0 to 99.0
Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine) PNC 9V N=(168,150)	90 Percentages of subjects Interval 85.0 to 94.0	89 Percentages of subjects Interval 83.0 to 93.0	93 Percentages of subjects Interval 88.0 to 97.0
Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine) PNC 14 N=(167,150)	99 Percentages of subjects Interval 96.0 to 100.0	99 Percentages of subjects Interval 97.0 to 100.0	99 Percentages of subjects Interval 96.0 to 100.0
Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine) PNC 18C N=(168,150)	71 Percentages of subjects Interval 63.0 to 77.0	76 Percentages of subjects Interval 68.0 to 82.0	86 Percentages of subjects Interval 79.0 to 91.0
Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine) PNC 19 F N=(168,150)	81 Percentages of subjects Interval 74.0 to 87.0	80 Percentages of subjects Interval 74.0 to 86.0	90 Percentages of subjects Interval 84.0 to 94.0
Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine) PNC 23 F N=(168,150)	88 Percentages of subjects Interval 82.0 to 92.0	89 Percentages of subjects Interval 83.0 to 93.0	94 Percentages of subjects Interval 89.0 to 97.0

SECONDARY outcome

Timeframe: 1 month postvaccination and 6-18 months postvaccination.

Population: Analysis was done on PP set (persistence subgroup).

Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titers ≥ 1:8, and titers ≥ 1:4 directed against N.meningitidis serogroup C (only for subjects enrolled in Australia).

Outcome measures

Outcome measures
Measure	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=17 Participants Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=14 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=13 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroup C hSBA ≥ 1:8, postvacc, Men C. N=(17,14,13)	100 Percentages of subjects Interval 80.0 to 100.0	86 Percentages of subjects Interval 57.0 to 98.0	92 Percentages of subjects Interval 64.0 to 100.0
Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroup C hSBA ≥ 1:8, perisistence, Men C. N=(17,14,13)	71 Percentages of subjects Interval 44.0 to 90.0	64 Percentages of subjects Interval 35.0 to 87.0	54 Percentages of subjects Interval 25.0 to 81.0
Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroup C hSBA ≥ 1:4, postvacc, Men C. N=(17,14,13)	100 Percentages of subjects Interval 80.0 to 100.0	93 Percentages of subjects Interval 66.0 to 100.0	100 Percentages of subjects Interval 75.0 to 100.0
Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroup C hSBA ≥ 1:4, persistence, Men C. N=(17,14,13)	76 Percentages of subjects Interval 50.0 to 93.0	71 Percentages of subjects Interval 42.0 to 92.0	77 Percentages of subjects Interval 46.0 to 95.0

SECONDARY outcome

Timeframe: 1 month postvaccination 6-18 months postvaccination

Population: Analysis was done on PP set (persistence subset).

Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 and titer ≥ 1:4 directed against N. meningitidis serogroups A, W and Y (only for subjects enrolled in Australia).

Outcome measures

Outcome measures
Measure	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=17 Participants Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=14 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y hSBA ≥ 1:8, postvacc, Men A (N=17,14)	88 Percentages of subjects Interval 64.0 to 99.0	42 Percentages of subjects Interval 15.0 to 72.0	—
Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y hSBA ≥ 1:8, persistence, Men A (N=16,14)	31 Percentages of subjects Interval 11.0 to 59.0	7 Percentages of subjects Interval 0.0 to 34.0	—
Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y hSBA ≥ 1:4, post-vacc, Men A (N=17,12)	100 Percentages of subjects Interval 80.0 to 100.0	50 Percentages of subjects Interval 21.0 to 79.0	—
Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y hSBA ≥ 1:4, persistence, Men A (N=16,14)	38 Percentages of subjects Interval 15.0 to 65.0	14 Percentages of subjects Interval 2.0 to 43.0	—
Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y hSBA ≥ 1:8, postvacc, Men W (N=17,12)	100 Percentages of subjects Interval 80.0 to 100.0	67 Percentages of subjects Interval 35.0 to 90.0	—
Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y hSBA ≥ 1:8, persistence, Men W (N=16,14)	75 Percentages of subjects Interval 48.0 to 93.0	71 Percentages of subjects Interval 42.0 to 92.0	—
Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y hSBA ≥ 1:4, postvacc, Men W (N=17,13)	86 Percentages of subjects Interval 57.0 to 98.0	0 Percentages of subjects Interval 0.0 to 25.0	—
Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y hSBA ≥ 1:4, persistence, Men W (N=16,14)	88 Percentages of subjects Interval 62.0 to 98.0	71 Percentages of subjects Interval 42.0 to 92.0	—
Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y hSBA ≥ 1:8, postvacc, Men Y (N=17,12)	100 Percentages of subjects Interval 80.0 to 100.0	33 Percentages of subjects Interval 10.0 to 65.0	—
Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y hSBA ≥ 1:8, persistence, Men Y (N=14,14)	79 Percentages of subjects Interval 49.0 to 95.0	79 Percentages of subjects Interval 49.0 to 95.0	—
Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y hSBA ≥ 1:4, postvacc, Men Y (N=17,12)	100 Percentages of subjects Interval 80.0 to 100.0	50 Percentages of subjects Interval 21.0 to 79.0	—
Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y hSBA ≥ 1:4, persistence, Men Y (N=14,14)	86 Percentages of subjects Interval 57.0 to 98.0	93 Percentages of subjects Interval 66.0 to 100.0	—

SECONDARY outcome

Timeframe: 1 month postvaccination and 6-18 months postvaccination.

Population: Analysis was done on PP set (subjects enrolled in Australia).

Persistence of immunogenicity of either one or two doses of MenACWY or one dose of MenC as measured by human serum bactericidal activity geometric mean titers directed against N.meningitidis serogroup C (only for subjects enrolled in Australia).

Outcome measures

Outcome measures
Measure	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=17 Participants Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=14 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=13 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C Month 13	241 Titers Interval 139.0 to 419.0	36 Titers Interval 19.0 to 66.0	30 Titers Interval 16.0 to 56.0
Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C 6 - 18 months after month 12	15 Titers Interval 7.45 to 29.0	12 Titers Interval 5.65 to 25.0	8.95 Titers Interval 4.15 to 19.0

SECONDARY outcome

Timeframe: 6-18 months postvaccination.

Population: Analysis was done on PP set (only for subjects enrolled in Australia).

Immunogenicity of two doses of MenACWY to one dose of MenACWY as measured by hSBA GMTs directed against N.meningitidis serogroups A, W, Y (only for subjects enrolled in Australia).

Outcome measures

Outcome measures
Measure	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=17 Participants Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=14 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y Month 12, Ser W (N= 17, 12)	180 Titers Interval 95.0 to 340.0	13 Titers Interval 6.26 to 28.0	—
Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y Month 12, Ser A (N= 17, 12)	47 Titers Interval 26.0 to 86.0	6.69 Titers Interval 3.28 to 14.0	—
Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y 6 - 18 months after Month 12, Ser A (N=16,14)	4.41 Titers Interval 2.78 to 7.0	2.78 Titers Interval 1.7 to 4.56	—
Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y 6 - 18 months after Month 12, Ser W (N=16,14)	20 Titers Interval 10.0 to 39.0	20 Titers Interval 9.77 to 42.0	—
Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y Month 12, Ser Y (N= 17, 12)	151 Titers Interval 93.0 to 246.0	5.13 Titers Interval 2.87 to 9.17	—
Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y 6 - 18 months after Month 12, Ser Y (N=14,14)	22 Titers Interval 12.0 to 38.0	16 Titers Interval 9.15 to 28.0	—

SECONDARY outcome

Timeframe: 1 month postvaccination.

Population: Analysis was done on PP set.

1. Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C. 2. Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C.

Outcome measures

Outcome measures
Measure	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=156 Participants Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=157 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=145 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C rSBA titer ≥ 1:8, prevacc (N=140,140,139)	72 Percentages of subjects Interval 64.0 to 79.0	4 Percentages of subjects Interval 1.0 to 8.0	1 Percentages of subjects Interval 0.0 to 5.0
Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C rSBA titer ≥ 1:8, postvacc (N=156,157,145)	98 Percentages of subjects Interval 94.0 to 100.0	92 Percentages of subjects Interval 86.0 to 96.0	97 Percentages of subjects Interval 92.0 to 99.0
Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C rSBA titer ≥ 1:128, prevacc (N=140,140,139)	31 Percentages of subjects Interval 23.0 to 39.0	1 Percentages of subjects Interval 0.018 to 4.0	0 Percentages of subjects Interval 0.0 to 3.0
Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C rSBA titer ≥ 1:128, postvacc (N=156,157,145)	92 Percentages of subjects Interval 87.0 to 96.0	75 Percentages of subjects Interval 68.0 to 82.0	88 Percentages of subjects Interval 82.0 to 93.0
Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C four fold rise (N=132,140,139)	86 Percentages of subjects Interval 79.0 to 92.0	91 Percentages of subjects Interval 86.0 to 95.0	96 Percentages of subjects Interval 92.0 to 99.0

SECONDARY outcome

Timeframe: 1 month postvaccination.

Population: Analysis was done on PP set.

1. Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y. 2. Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=76 Participants Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=83 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y rSBA titer ≥ 1:128, Men A	100 Percentages of subjects Interval 95.0 to 100.0	98 Percentages of subjects Interval 92.0 to 100.0	—
Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y rSBA titer ≥ 1:128, Men W	96 Percentages of subjects Interval 89.0 to 99.0	93 Percentages of subjects Interval 85.0 to 97.0	—
Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y rSBA titer ≥ 1:128, Men Y	89 Percentages of subjects Interval 80.0 to 95.0	86 Percentages of subjects Interval 76.0 to 92.0	—
Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y rSBA titer ≥ 1:8, Men A	100 Percentages of subjects Interval 95.0 to 100.0	98 Percentages of subjects Interval 92.0 to 100.0	—
Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y rSBA titer ≥ 1:8, Men W	100 Percentages of subjects Interval 95.0 to 100.0	95 Percentages of subjects Interval 88.0 to 99.0	—
Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y rSBA titer ≥ 1:8, Men Y	97 Percentages of subjects Interval 91.0 to 100.0	88 Percentages of subjects Interval 79.0 to 94.0	—
Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y Four Fold Rise of rSBA titer, Men A	75 Percentages of subjects Interval 64.0 to 85.0	95 Percentages of subjects Interval 88.0 to 99.0	—
Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y Four Fold Rise of rSBA titer, Men W	95 Percentages of subjects Interval 86.0 to 99.0	95 Percentages of subjects Interval 87.0 to 99.0	—
Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y Four Fold Rise of rSBA titer, Men Y	91 Percentages of subjects Interval 75.0 to 98.0	87 Percentages of subjects Interval 74.0 to 95.0	—

SECONDARY outcome

Timeframe: 1 month postvaccination.

Population: Analysis was done on PP set.

1. Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C. 2. Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C.

Outcome measures

Outcome measures
Measure	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=156 Participants Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=157 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=145 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C GMT, prevacc (N=140,140,139)	26 Titers Interval 21.0 to 33.0	2.22 Titers Interval 1.76 to 2.8	2.03 Titers Interval 1.62 to 2.54
Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C GMT, postvacc (N=156,157,145)	353 Titers Interval 260.0 to 479.0	131 Titers Interval 98.0 to 176.0	266 Titers Interval 197.0 to 359.0

SECONDARY outcome

Timeframe: 1 month postvaccination.

Population: Analysis was done on PP set.

1. Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with GMT of SBA with rabbit complement (rSBA) against Serogroup A, W, Y. 2. Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup A, W, Y.

Outcome measures

Outcome measures
Measure	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=76 Participants Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=83 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y GMT, prevacc, Men A (N=73,82)	281 Titers Interval 134.0 to 587.0	6.83 Titers Interval 3.34 to 14.0	—
Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y GMT, postvacc, Men A	3136 Titers Interval 2013.0 to 4886.0	3258 Titers Interval 2113.0 to 5022.0	—
Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y GMT, prevacc, Men W (N=59,75)	20 Titers Interval 12.0 to 33.0	2.32 Titers Interval 1.46 to 3.69	—
Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y GMT, postvacc, Men W	708 Titers Interval 421.0 to 1191.0	1306 Titers Interval 786.0 to 2169.0	—
Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y GMT, prevacc, Men Y (N=32,49)	22 Titers Interval 12.0 to 40.0	2.4 Titers Interval 1.42 to 4.06	—
Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y GMT, postvacc, Men Y (N=76,81)	574 Titers Interval 320.0 to 1028.0	598 Titers Interval 336.0 to 1066.0	—

SECONDARY outcome

Timeframe: From day 1 to day 7 postvaccination

Population: Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.

Safety was assessed as the number of subjects who reported solicited local reactions from day 1 to day 7 postvaccination for all the three vaccination groups. safety was assessed as the number of subjects who reported solicited systemic reactions from day 1 to day 7 Following the Month 12 vaccination in all three vaccination groups

Outcome measures

Outcome measures
Measure	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=195 Participants Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=192 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=179 Participants Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Any Local N=(195,192,179)	130 Number of subjects	131 Number of subjects	135 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Tenderness (MenACWY-CRM197/MenC)N=(194,192,178)	57 Number of subjects	65 Number of subjects	44 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Erythema (MenACWY-CRM197/MenC) N=(194,192,178)	94 Number of subjects	62 Number of subjects	64 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Induration (MenACWY-CRM197/MenC) N=(194,192,178)	53 Number of subjects	24 Number of subjects	43 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Tenderness (DTPa-IPV-HepB-Hib) N=(189,190,176)	62 Number of subjects	83 Number of subjects	73 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Erythema (DTPa-IPV-HepB-Hib)B N=(189,190,176)	80 Number of subjects	81 Number of subjects	96 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Induration (DTPa-IPV-HepB-Hib) N=(189,190,176)	62 Number of subjects	66 Number of subjects	81 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Tenderness (PCV7) N=(189,190,176)	58 Number of subjects	68 Number of subjects	60 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Erythema (PCV7) N=(189,190,176)	71 Number of subjects	68 Number of subjects	77 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Induration (PCV7) N=(189,190,176)	50 Number of subjects	50 Number of subjects	59 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Any Systemic reactions N=(195,192,179)	173 Number of subjects	149 Number of subjects	150 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Change in eating habits N=(189, 191,177)	62 Number of subjects	66 Number of subjects	49 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Sleepiness N=(191,191,179)	93 Number of subjects	99 Number of subjects	94 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Persistent crying N=(189,191,177)	77 Number of subjects	93 Number of subjects	76 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Irritability N=(191,191,179)	67 Number of subjects	68 Number of subjects	73 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Vomiting N=(191,191,179)	10 Number of subjects	18 Number of subjects	16 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Diarrhoea N=(191,191,179)	26 Number of subjects	41 Number of subjects	42 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Rash N=(191,191,179)	7 Number of subjects	17 Number of subjects	7 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Fever ≥ 38.5C N=(191,192,179)	54 Number of subjects	62 Number of subjects	50 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Others N=(195,192,179)	64 Number of subjects	62 Number of subjects	62 Number of subjects
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Analgesic-Antipyretic medication N=(191,192,179)	58 Number of subjects	62 Number of subjects	62 Number of subjects

Adverse Events

MenACWY-CRM197 (2dose) + Concomitant Vaccines

Serious events: 13 serious events

Other events: 192 other events

Deaths: 0 deaths

MenACWY-CRM197 (1dose) + Concomitant Vaccines

Serious events: 19 serious events

Other events: 184 other events

Deaths: 0 deaths

MenC (1dose) + Concomitant Vaccines

Serious events: 12 serious events

Other events: 170 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	MenACWY-CRM197 (2dose) + Concomitant Vaccines n=195 participants at risk Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenACWY-CRM197 (1dose) + Concomitant Vaccines n=192 participants at risk Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	MenC (1dose) + Concomitant Vaccines n=179 participants at risk Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
Infections and infestations Gastroenteritis	11.3% 22/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	7.3% 14/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	6.7% 12/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
Infections and infestations Nasopharyngitis	9.7% 19/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	7.3% 14/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	7.8% 14/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
Infections and infestations Otitis media	16.9% 33/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	11.5% 22/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	11.7% 21/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
Infections and infestations Rhinitis	12.3% 24/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	3.6% 7/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	4.5% 8/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
Infections and infestations Upper respiratory tract infection	34.4% 67/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	16.1% 31/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	16.2% 29/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
Infections and infestations Viral infection	19.5% 38/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	13.5% 26/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	14.5% 26/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
Nervous system disorders Crying	51.3% 100/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	48.4% 93/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	42.5% 76/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
Nervous system disorders Somnolence	64.6% 126/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	51.6% 99/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	52.5% 94/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
Psychiatric disorders Eating disorder	44.6% 87/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	34.4% 66/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	27.4% 49/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
Respiratory, thoracic and mediastinal disorders Cough	12.8% 25/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	5.7% 11/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	5.6% 10/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
Skin and subcutaneous tissue disorders Dermatitis Diaper	12.3% 24/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	10.4% 20/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	5.0% 9/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
Skin and subcutaneous tissue disorders Rash	14.4% 28/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	12.5% 24/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	3.9% 7/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
Eye disorders Conjunctivitis	18.5% 36/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	7.8% 15/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	10.1% 18/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
Gastrointestinal disorders Diarrhoea	27.7% 54/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	22.9% 44/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	24.6% 44/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
Gastrointestinal disorders Enteritis	6.7% 13/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	2.1% 4/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	2.8% 5/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
Gastrointestinal disorders Teething	10.8% 21/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	3.1% 6/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	3.9% 7/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
Gastrointestinal disorders Vomiting	19.5% 38/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	12.5% 24/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	10.6% 19/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
General disorders Injection site erythema	56.4% 110/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	53.1% 102/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	61.5% 110/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
General disorders Injection site induration	44.1% 86/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	42.7% 82/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	58.1% 104/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
General disorders Injection site pain	46.2% 90/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	50.5% 97/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	46.9% 84/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
General disorders Irritability	43.6% 85/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	35.4% 68/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	40.8% 73/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
General disorders Pyrexia	65.1% 127/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	57.8% 111/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	57.0% 102/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.
Infections and infestations Bronchitis	24.1% 47/195 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	15.1% 29/192 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.	16.2% 29/179 • Solicited Adverse Events (AEs) were collected from Days 1-7 after any vaccination. Other AEs and Serious AEs were collected from days 1 to 180. Data collected from one site were not included in the data analysis for outcome measures and the AE section.