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

A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Toddlers

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00667602

Enrollment

662

Registered

2008-04-28

Start date

2008-03-31

Completion date

2010-10-31

Last updated

2013-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningococcal Meningitis

Keywords

Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Toddlers, Infants, Concomitant Vaccination

Brief summary

The primary immunogenicity objective is to assess and compare the immunogenicity of one dose of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured by the percentage of subjects with serum bactericidal titers directed against N. meningitidis serogroup C ≥ 1:8 obtained in the serum bactericidal assay using human complement (hSBA).

Interventions

BIOLOGICALMenACWY-CRM197 (two doses)

Two 0.5mL doses of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.

BIOLOGICALMenC

One 0.5mL dose of MenC vaccine was administered by intramuscular injection.

BIOLOGICALPCV7

One 0.5mL dose of Pneumococcal 7-valent Conjugate Vaccine (PCV7) was administered by intramuscular injection.

BIOLOGICALDTPa-IPV-HepB-Hib

One 0.5mL dose of Combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-IPV-HepB-Hib) vaccine was administered by intramuscular injection.

BIOLOGICALMenACWY-CRM197 (one dose)

One 0.5mL dose of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 8 Months

Healthy volunteers

Yes

Inclusion criteria

* infants 6 to 8 months old inclusive, who were born after full term pregnancy and previously received three doses of both Prevenar and Infanrix-hexa vaccines at least 30 days before study entry

Exclusion criteria

* who previously received any meningococcal vaccine; * who have had a previous confirmed or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis; * who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; * Subjects with any serious, acute or chronic progressive disease

Design outcomes

Primary

Measure	Time frame	Description
Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C	1 month postvaccination	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.

Secondary

Measure	Time frame	Description
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y	1 month postvaccination.	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.
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y	1 month postvaccination.	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.
Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C	1 month postvaccination	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.
Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y	1 month postvaccination	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.
Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y	1 month postvaccination	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.
Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine)	1 month postvaccination	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.
Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	1 month postvaccination	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.
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	1 month postvaccination and 6-18 months postvaccination.	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).
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C	1 month postvaccination	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.
Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C	1 month postvaccination and 6-18 months postvaccination.	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).
Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y	6-18 months postvaccination.	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).
Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C	1 month postvaccination.	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.
Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y	1 month postvaccination.	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.
Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C	1 month postvaccination.	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.
Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y	1 month postvaccination.	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.
Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination	From day 1 to day 7 postvaccination	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
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	1 month postvaccination 6-18 months postvaccination	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).

Countries

Germany

Participant flow

Pre-assignment details

All participants enrolled were included in the trial.

Participants by arm

Arm	Count
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.	219
MenACWY-CRM197 (1dose) + Concomitant Vaccines Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	228
MenC (1dose) + Concomitant Vaccines Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	215
Total	662

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Administrative reason	0	0	2
Overall Study	Lost to Follow-up	4	5	6
Overall Study	Protocol Violation	0	1	0
Overall Study	Withdrawal by Subject	4	9	10

Baseline characteristics

Characteristic	MenACWY-CRM197 (2dose) + Concomitant Vaccines	MenACWY-CRM197 (1dose) + Concomitant Vaccines	MenC (1dose) + Concomitant Vaccines	Total
Age Continuous	208.4 Days STANDARD_DEVIATION 23.7	209.8 Days STANDARD_DEVIATION 22.2	209.3 Days STANDARD_DEVIATION 21.9	209.2 Days STANDARD_DEVIATION 22.6
Sex: Female, Male Female	105 Participants	106 Participants	94 Participants	305 Participants
Sex: Female, Male Male	114 Participants	122 Participants	121 Participants	357 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	192 / 195	184 / 192	170 / 179
serious Total, serious adverse events	13 / 195	19 / 192	12 / 179

Outcome results

Primary

Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C

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.

Time frame: 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.

Arm	Measure	Value (NUMBER)
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C	83 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C	92 Percentages of subjects

Comparison: The primary criterion for immunogenicity was that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY-CRM197 and MenC in the percentage of subjects with hSBA ≥1:8 for serogroup C at 1 month following the 12 months vaccination was greater than -10% .95% CI: [-15, -1]Miettinen and Nurminen

Secondary

Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C

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.

Time frame: 1 month postvaccination

Population: Analysis was done on PP set.

Arm	Measure	Group	Value (MEAN)
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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)	2.29 Titers
MenC (1dose) + Concomitant Vaccines	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)	31 Titers

Comparison: For comparison of the Geometric Mean Titers, prevaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.95% CI: [0.76, 1.12]ANOVA

Comparison: For comparison of the Geometric Mean Titers, one month postvaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.95% CI: [0.57, 0.93]ANOVA

Secondary

Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y

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.

Time frame: 1 month postvaccination

Population: Analysis was done on PP set.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y	postvacc, Men C (N=167,153)	249 Titers
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y	postvacc Men A (N=166,23)	75 Titers
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y	prevacc, Men W (N=157,23)	14 Titers
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y	postvacc, Men W (N=165,22)	213 Titers
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y	prevacc, Men A (N=159,23)	3.4 Titers
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y	prevacc, Men Y (N=156,23)	11 Titers
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y	prevacc, Men C (N=161,152)	23 Titers
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y	postvacc, Men Y (N=163,22)	156 Titers
MenC (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y	postvacc, Men Y (N=163,22)	1.93 Titers
MenC (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y	prevacc, Men A (N=159,23)	2 Titers
MenC (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y	postvacc Men A (N=166,23)	2.22 Titers
MenC (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y	prevacc, Men C (N=161,152)	2.29 Titers
MenC (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y	postvacc, Men C (N=167,153)	31 Titers
MenC (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y	postvacc, Men W (N=165,22)	2 Titers
MenC (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y	prevacc, Men Y (N=156,23)	1.76 Titers
MenC (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y	prevacc, Men W (N=157,23)	1.71 Titers

Comparison: For comparison of the GMTs (prevaccination), MenACWY was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the ratio of the MenACWY to MenC GMTs for serogroup C was greater than 0.5 .95% CI: [8.43, 13]ANOVA

Comparison: For comparison of the GMTs (one month postvaccination), MenACWY was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the ratio of the MenACWY to MenC GMTs for serogroup C was greater than 0.5.95% CI: [6.35, 10]ANOVA

Secondary

Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y

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.

Time frame: 1 month postvaccination

Population: Analysis was done on PP set.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y	prevacc, Men A (N=171)	1.99 Titers
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y	postvacc Men A (N=172)	10 Titers
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y	prevacc, Men W (N=168)	2.12 Titers
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y	postvacc Men W (N=170)	14 Titers
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y	prevacc, Men Y (N=160)	1.92 Titers
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y	postvacc Men Y (N=167)	7.05 Titers

Secondary

Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination

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

Time frame: 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.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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)	62 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	131 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	65 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	62 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	24 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	83 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	81 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	66 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	68 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	68 Number of subjects
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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)	149 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	66 Number of subjects
MenC (1dose) + Concomitant Vaccines	Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination	Sleepiness N=(191,191,179)	99 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	93 Number of subjects
MenC (1dose) + Concomitant Vaccines	Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination	Irritability N=(191,191,179)	68 Number of subjects
MenC (1dose) + Concomitant Vaccines	Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination	Vomiting N=(191,191,179)	18 Number of subjects
MenC (1dose) + Concomitant Vaccines	Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination	Diarrhoea N=(191,191,179)	41 Number of subjects
MenC (1dose) + Concomitant Vaccines	Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination	Rash N=(191,191,179)	17 Number of subjects
MenC (1dose) + Concomitant Vaccines	Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination	Others N=(195,192,179)	62 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	62 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	60 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	44 Number of subjects
MenC (1dose) + Concomitant Vaccines	Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination	Irritability N=(191,191,179)	73 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	81 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	62 Number of subjects
MenC (1dose) + Concomitant Vaccines	Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination	Vomiting N=(191,191,179)	16 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	96 Number of subjects
MenC (1dose) + Concomitant Vaccines	Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination	Others N=(195,192,179)	62 Number of subjects
MenC (1dose) + Concomitant Vaccines	Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination	Diarrhoea N=(191,191,179)	42 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	73 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	135 Number of subjects
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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)	150 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	43 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	49 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	59 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	64 Number of subjects
MenC (1dose) + Concomitant Vaccines	Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination	Sleepiness N=(191,191,179)	94 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	77 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	50 Number of subjects
MenC (1dose) + Concomitant Vaccines	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)	76 Number of subjects

Secondary

Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C

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.

Time frame: 1 month postvaccination

Population: Analysis was done on PP set.

Arm	Measure	Value (NUMBER)
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C	90 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C	97 Percentages of subjects

Comparison: The primary criterion for immunogenicity was that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY-CRM197 and MenC in the percentage of subjects with hSBA ≥ 1:4 for serogroup C at 1 month following the 12 months vaccination was greater than -10%.95% CI: [-13, -2]Miettinen and Nurminen

Secondary

Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y

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.

Time frame: 1 month postvaccination.

Population: Analysis was done on PP set.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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)	0 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	6 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	7 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	92 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	0 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	0 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	97 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	5 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	0 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	0 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	0 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	5 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	5 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	0 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	5 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	0 Percentages of subjects

Comparison: Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:8, prevaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.95% CI: [64, 79]Percentage difference

Comparison: Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:8, one month postvaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.95% CI: [3, 13]Percentage difference

Comparison: Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:4, prevaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.95% CI: [73, 86]Percentage difference

Comparison: Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:4, one month postvaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.95% CI: [-2, 5]Percentage difference

Secondary

Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y

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.

Time frame: 1 month postvaccination.

Population: Analysis was done on PP set.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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

Secondary

Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y

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.

Time frame: 1 month postvaccination.

Population: Analysis was done on PP set.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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	87 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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	98 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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	93 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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	86 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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	98 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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	95 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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	88 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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	95 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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

Secondary

Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C

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.

Time frame: 1 month postvaccination.

Population: Analysis was done on PP set.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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)	1 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	4 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	92 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	75 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	91 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	96 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	88 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	1 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	0 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	97 Percentages of subjects

Comparison: For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.95% CI: [63, 78]Miettinen and Nurminen

Comparison: For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.95% CI: [-3, 6]Miettinen and Nurminen

Comparison: For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.95% CI: [24, 39]Miettinen and Nurminen

Comparison: For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.95% CI: [-2, 4]Miettinen and Nurminen

Comparison: For the comparisons to MenC based on percentages of subjects with response (four-fold rise in titers), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.95% CI: [-17, -4]Miettinen and Nurminen

Secondary

Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine)

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.

Time frame: 1 month postvaccination

Population: Analysis was done on PP set.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine)	PT ELISA N=(159,165,151)	95 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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)	98 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine)	FHA ELISA N=(160,169,152)	91 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine)	PRN ELISA N=(160,169,152)	98 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine)	polio 2 N=157,(161,148)	99 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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)	98 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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)	97 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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)	98 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine)	polio 1 N=(157,161,148)	99 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine)	FHA ELISA N=(160,169,152)	96 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	99 Percentages of subjects

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥0.1 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-2, 2]Miettinen and Nurminen

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥0.1 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-2, 2]Miettinen and Nurminen

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥1.0 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-3, 5]Miettinen and Nurminen

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥1.0 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-3, 4]Miettinen and Nurminen

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 0.1 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-2, 2]Miettinen and Nurminen

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 0.1 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, for any of the antigens, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-2, 2]Miettinen and Nurminen

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 1.0 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-6, 3]Miettinen and Nurminen

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 1.0 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-6, 3]Miettinen and Nurminen

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (polio 1, one month postvaccination), given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-2, 4]Miettinen and Nurminen

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (polio 1, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-2, 4]Miettinen and Nurminen

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (polio 2, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-2, 3]Miettinen and Nurminen

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (polio 2, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-3, 2]Miettinen and Nurminen

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (polio 3, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-3, 3]Miettinen and Nurminen

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (Polio 3, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-2, 3]Miettinen and Nurminen

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 0.15 μg/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-2, 2]Miettinen and Nurminen

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 0.15 μg/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-2, 2]Miettinen and Nurminen

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 1.0 μg/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-2, 4]Miettinen and Nurminen

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 1.0 μg/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-4, 2]Miettinen and Nurminen

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (Hep B, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-3, 3]Miettinen and Nurminen

Comparison: Immunogenicity of DTPa-IPV-HepB-Hib (Hep B, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-4, 3]Miettinen and Nurminen

Secondary

Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)

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.

Time frame: 1 month postvaccination

Population: Analysis was done on PP set.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 6B N=(168,149)	92 Percentages of subjects
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 18C N=(168,150)	71 Percentages of subjects
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 14 N=(167,150)	99 Percentages of subjects
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 4 N=(168,150)	83 Percentages of subjects
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 23 F N=(168,150)	88 Percentages of subjects
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 19 F N=(168,150)	81 Percentages of subjects
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 9V N=(168,150)	90 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 14 N=(167,150)	99 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 4 N=(168,150)	82 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 6B N=(168,149)	91 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 9V N=(168,150)	89 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 18C N=(168,150)	76 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 19 F N=(168,150)	80 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 23 F N=(168,150)	89 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 18C N=(168,150)	86 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 6B N=(168,149)	97 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 23 F N=(168,150)	94 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 19 F N=(168,150)	90 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 14 N=(167,150)	99 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 9V N=(168,150)	93 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)	PNC 4 N=(168,150)	87 Percentages of subjects

Comparison: Immunogenicity of PCV7 (PNC4, one month postvaccination)given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-13, 3]Miettinen and Nurminen

Comparison: Immunogenicity of PCV7(PNC 6B, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-12, -1]Miettinen and Nurminen

Comparison: Immunogenicity of PCV7(PnC 9V, one month postvaccination) given concomitantly with MenACWY-CRM197 or MenC was considered non-inferior, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than -10%.95% CI: [-11, 2]Miettinen and Nurminen

Comparison: Immunogenicity of PCV7 (PNC 14, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-3, 3]Miettinen and Nurminen

Comparison: Immunogenicity of PCV7( PNC 18C, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-19, -2]Miettinen and Nurminen

Comparison: Immunogenicity of PCV7 (PNC 19F, one month postvaccination), given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-17, -2]Miettinen and Nurminen

Comparison: Immunogenicity of PCV7 (PNC 23F, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-12, 1]Miettinen and Nurminen

Comparison: Immunogenicity of PCV7 (PNC4, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-12, 4]Miettinen and Nurminen

Comparison: Immunogenicity of PCV7 (PNC6B, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-11, 0]Miettinen and Nurminen

Comparison: Immunogenicity of PCV7 (PNC 9V, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-10, 3]Miettinen and Nurminen

Comparison: Immunogenicity of PCV7 (PNC14, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-4, 3]Miettinen and Nurminen

Comparison: Immunogenicity of PCV7 (PNC18C, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-24, -6]Miettinen and Nurminen

Comparison: Immunogenicity of PCV7 (PNC19F, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-17, -1]Miettinen and Nurminen

Comparison: Immunogenicity of PCV7 (PNC23F, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.95% CI: [-13, 0]Miettinen and Nurminen

Secondary

Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C

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).

Time frame: 1 month postvaccination and 6-18 months postvaccination.

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C	Month 13	241 Titers
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C	6 - 18 months after month 12	15 Titers
MenC (1dose) + Concomitant Vaccines	Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C	Month 13	36 Titers
MenC (1dose) + Concomitant Vaccines	Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C	6 - 18 months after month 12	12 Titers
MenC (1dose) + Concomitant Vaccines	Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C	6 - 18 months after month 12	8.95 Titers
MenC (1dose) + Concomitant Vaccines	Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C	Month 13	30 Titers

Secondary

Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y

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).

Time frame: 6-18 months postvaccination.

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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)	16 Titers
MenC (1dose) + Concomitant Vaccines	Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y	Month 12, Ser A (N= 17, 12)	6.69 Titers
MenC (1dose) + Concomitant Vaccines	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)	2.78 Titers
MenC (1dose) + Concomitant Vaccines	Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y	Month 12, Ser W (N= 17, 12)	13 Titers
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y	Month 12, Ser Y (N= 17, 12)	5.13 Titers

Secondary

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

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).

Time frame: 1 month postvaccination and 6-18 months postvaccination.

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

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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)	71 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	86 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	93 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	64 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	77 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	54 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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)	92 Percentages of subjects

Secondary

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

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).

Time frame: 1 month postvaccination 6-18 months postvaccination

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

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenACWY-CRM197 (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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)	50 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	42 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	0 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	7 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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
MenC (1dose) + Concomitant Vaccines	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)	50 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	71 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	14 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	93 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	67 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	33 Percentages of subjects
MenC (1dose) + Concomitant Vaccines	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)	71 Percentages of subjects

Secondary

Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y

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.

Time frame: 1 month postvaccination.

Population: Analysis was done on PP set.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y	GMT, prevacc, Men A (N=73,82)	281 Titers
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y	GMT, postvacc, Men A	3136 Titers
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y	GMT, prevacc, Men W (N=59,75)	20 Titers
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y	GMT, postvacc, Men W	708 Titers
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y	GMT, prevacc, Men Y (N=32,49)	22 Titers
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y	GMT, postvacc, Men Y (N=76,81)	574 Titers
MenC (1dose) + Concomitant Vaccines	Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y	GMT, prevacc, Men Y (N=32,49)	2.4 Titers
MenC (1dose) + Concomitant Vaccines	Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y	GMT, prevacc, Men A (N=73,82)	6.83 Titers
MenC (1dose) + Concomitant Vaccines	Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y	GMT, postvacc, Men W	1306 Titers
MenC (1dose) + Concomitant Vaccines	Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y	GMT, postvacc, Men A	3258 Titers
MenC (1dose) + Concomitant Vaccines	Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y	GMT, postvacc, Men Y (N=76,81)	598 Titers
MenC (1dose) + Concomitant Vaccines	Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y	GMT, prevacc, Men W (N=59,75)	2.32 Titers

Secondary

Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C

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.

Time frame: 1 month postvaccination.

Population: Analysis was done on PP set.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C	GMT, prevacc (N=140,140,139)	26 Titers
MenACWY-CRM197 (1dose) + Concomitant Vaccines	Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C	GMT, postvacc (N=156,157,145)	353 Titers
MenC (1dose) + Concomitant Vaccines	Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C	GMT, prevacc (N=140,140,139)	2.22 Titers
MenC (1dose) + Concomitant Vaccines	Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C	GMT, postvacc (N=156,157,145)	131 Titers
MenC (1dose) + Concomitant Vaccines	Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C	GMT, prevacc (N=140,140,139)	2.03 Titers
MenC (1dose) + Concomitant Vaccines	Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C	GMT, postvacc (N=156,157,145)	266 Titers

Comparison: For comparison of the Geometric Mean Titers at one month postvaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.95% CI: [0.96, 1.83]ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026

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

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C

Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C

Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y

Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y

Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination

Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C

Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y

Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y

Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y

Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C

Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine)

Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)

Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C

Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y

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

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

Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y

Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C