Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children

A Phase 2, Randomized, Single-blind, Controlled, Single-Center Study to Compare the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Children 2-10 Years of Age and an Open-label Study to Assess the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine Administered to Healthy Toddlers 12-23 Months of Age

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00262028

Enrollment

910

Registered

2005-12-06

Start date

2005-04-30

Completion date

2006-11-30

Last updated

2016-02-11

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

Conditions

Prevention of Meningococcal Disease

Brief summary

The purpose of this study is to evaluate the safety and immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10 years

Interventions

BIOLOGICALMenACWY-CRM Vaccine

BIOLOGICALMenACWY-PS Vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

12 Months to 10 Years

Inclusion criteria

* Group 1: Healthy children 2-10 years of age; * Group 2: Healthy toddlers 12-23 months of age; who are up to date with age appropriate immunizations for diphtheria, tetanus, pertussis, polio, hepatitis B, Hemophilus influenzae type b, and pneumococcus.

Exclusion criteria

* Group 1: Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease. * Group 2: Subjects with a previous or suspected disease caused by N. meningitidis or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease.

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	1 month post vaccination (Day 29)	Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.

Secondary

Measure	Time frame	Description
Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine	1 month post vaccination (Day 29)	Percentage of subjects (12-23 months old) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y after receiving one dose of MenACWY-CRM vaccine compared with percentage of subjects (3-5 years old) with hSBA ≥ 1:4 after one dose of licensed MenACWY-PS vaccine.
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	1 month post vaccination (Day 29)	hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or the licensed MenACWY-PS vaccine.
hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	1 month post vaccination (Day 29)	hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-5 years of age and 6-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or licensed MenACWY-PS vaccine.
hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine	1 month post vaccination (Day 29)	hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (12-23 months old), one month after receiving one dose of MenACWY-CRM vaccine compared with hSBA GMT in 3-5 year old subjects after receiving one dose of licensed MenACWY-PS vaccine.
Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	12 months post vaccination (Day 360)	Number of subjects (2-10 years, 2-5 years and 6-10 years old subjects) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, 12 months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	1 month post vaccination (Day 29)	Percentages of subjects (2-5 years of age and 6-10 years of age) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Day 1 to 7 post vaccination	Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Day 1 to 7 post vaccination	Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.
Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years	Day 1- Day 360 (throughout the study)	Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Day 1- Day 360 (Throughout the study)	Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	12 months post vaccination (Day 360)	hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years, 2-5 years and 6-10 years old), twelve months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.

Countries

United States

Participant flow

Recruitment details

Subjects were recruited from a single center.

Pre-assignment details

All enrolled subjects participated in this study.

Participants by arm

Arm	Count
MenACWY (2-5 Years Old) Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.	152
MenACWY-PS (2-5 Years Old) Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.	153
MenACWY (6-10 Years Old) Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine	157
MenACWY-PS (6-10 Years Old) Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.	157
MenACWY (12-15 Months Old) Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.	74
MenACWY-PnC (12-15 Months Old) Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine.	73
MenACWY (16-23 Months Old) Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.	71
MenACWY+DTaP (16-23 Months Old) Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine.	73
MenACWY+PS (3-5 YearsOld) Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.	100
Total	1,010

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008
Overall Study	Administrative Reason	11	14	9	12	6	7	4	6	10
Overall Study	Lost to Follow-up	7	7	5	5	4	3	3	5	6
Overall Study	Protocol Violation	0	0	0	1	0	0	0	0	0
Overall Study	Unable to classify	0	3	0	0	0	0	0	0	1
Overall Study	Withdrawal by Subject	6	3	6	5	2	3	5	7	2

Baseline characteristics

Characteristic	MenACWY-PS (2-5 Years Old)	MenACWY (6-10 Years Old)	MenACWY-PS (6-10 Years Old)	MenACWY (12-15 Months Old)	MenACWY-PnC (12-15 Months Old)	MenACWY (16-23 Months Old)	MenACWY+DTaP (16-23 Months Old)	MenACWY+PS (3-5 YearsOld)	Total	MenACWY (2-5 Years Old)
Age, Continuous	3.3 years STANDARD_DEVIATION 1.2	8.0 years STANDARD_DEVIATION 1.5	8.0 years STANDARD_DEVIATION 1.4	NA years	NA years	NA years	NA years	NA years	5.7 years STANDARD_DEVIATION 2.7	NA months
Sex: Female, Male Female	79 Participants	80 Participants	78 Participants	NA Participants	NA Participants	NA Participants	NA Participants	NA Participants	NA Participants	NA Participants
Sex: Female, Male Male	NA Participants	NA Participants	NA Participants	44 Participants	44 Participants	40 Participants	37 Participants	49 Participants	NA Participants	NA Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	82 / 151	69 / 153	81 / 157	64 / 157	64 / 74	61 / 71	62 / 71	59 / 73	40 / 100
serious Total, serious adverse events	2 / 151	1 / 153	0 / 157	0 / 157	2 / 74	3 / 71	3 / 71	2 / 73	1 / 100

Outcome results

Primary

Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine

Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.

Time frame: 1 month post vaccination (Day 29)

Population: Analysis was done on per protocol population i.e. all subjects who received one dose of vaccine and provided serum samples at the relevant time points (day 1, day 29 and day 360) and had no major protocol deviation.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM (2-10 Years Old)	Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup A (Day 1), N=280, 281	6 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup A (Day 29), N=280, 281	228 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup C (Day 1)	80 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup C (Day 29)	232 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup W (Day 1), N=279, 282	111 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup W (Day 29), N=279, 282	263 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=280, 282	61 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup Y (Day 29), N=280, 282	254 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup Y (Day 29), N=280, 282	167 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup A (Day 1), N=280, 281	1 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup W (Day 1), N=279, 282	108 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup A (Day 29), N=280, 281	125 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=280, 282	68 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup C (Day 1)	81 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup W (Day 29), N=279, 282	202 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup C (Day 29)	181 Subjects

Comparison: Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A95% CI: [29, 44]

Comparison: Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C95% CI: [12, 26]

Comparison: Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W95% CI: [17, 29]

Comparison: No inferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y95% CI: [25, 38]

Comparison: Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup95% CI: [29, 44]

Comparison: Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup95% CI: [12, 26]

Comparison: Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup95% CI: [17, 29]

Comparison: Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup95% CI: [25, 38]

Secondary

hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine

hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (12-23 months old), one month after receiving one dose of MenACWY-CRM vaccine compared with hSBA GMT in 3-5 year old subjects after receiving one dose of licensed MenACWY-PS vaccine.

Time frame: 1 month post vaccination (Day 29)

Population: Analysis was done on per protocol population.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine	Serogroup A (Day 1), N=240,91	2 Titer
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine	Serogroup A (Day 29), N=240,91	18 Titer
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine	Serogroup C (Day 1), N=241,91	2.13 Titer
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine	Serogroup C (Day 29), N=241,91	22 Titer
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine	Serogroup W (Day 1), N=240,91	2.13 Titer
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine	Serogroup W (Day 29), N=240,91	18 Titer
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine	Serogroup Y (Day 1), N=238,91	2.11 Titer
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine	Serogroup Y (Day 29), N=238,91	11 Titer
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine	Serogroup Y (Day 29), N=238,91	8.48 Titer
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine	Serogroup A (Day 1), N=240,91	2 Titer
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine	Serogroup W (Day 1), N=240,91	3.91 Titer
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine	Serogroup A (Day 29), N=240,91	7.18 Titer
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine	Serogroup Y (Day 1), N=238,91	2.69 Titer
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine	Serogroup C (Day 1), N=241,91	2.44 Titer
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine	Serogroup W (Day 29), N=240,91	9.52 Titer
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine	Serogroup C (Day 29), N=241,91	7.09 Titer

Secondary

hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine

hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years, 2-5 years and 6-10 years old), twelve months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.

Time frame: 12 months post vaccination (Day 360)

Population: Analysis was done on per protocol population.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 1), N=252,240,119,114,133,126	3.04 Titer
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 360), N=253,238,119114,134,124	3.88 Titer
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 1), N=253,238,119,114,134,124	2.06 Titer
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 360), N=252,240,119,114,133,126	11 Titer
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 1), N=249,237,119,113,130,124	5.5 Titer
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 360), N=249,237,119,113,130,124	42 Titer
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=250,239,118,113,132,126	3.29 Titer
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 360), N=250,239,118,113,132,126	27 Titer
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 360), N=252,240,119,114,133,126	9.02 Titer
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 360), N=250,239,118,113,132,126	5.29 Titer
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 1), N=253,238,119,114,134,124	2.02 Titer
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=250,239,118,113,132,126	3.4 Titer
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 360), N=249,237,119,113,130,124	7.57 Titer
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 1), N=252,240,119,114,133,126	3.43 Titer
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 360), N=253,238,119114,134,124	3 Titer
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 1), N=249,237,119,113,130,124	5.38 Titer
MenACWY-CRM (6-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 360), N=253,238,119114,134,124	3.15 Titer
MenACWY-CRM (6-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 1), N=252,240,119,114,133,126	2.77 Titer
MenACWY-CRM (6-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 360), N=252,240,119,114,133,126	7.53 Titer
MenACWY-CRM (6-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 360), N=250,239,118,113,132,126	24 Titer
MenACWY-CRM (6-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 1), N=249,237,119,113,130,124	4.4 Titer
MenACWY-CRM (6-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 360), N=249,237,119,113,130,124	36 Titer
MenACWY-CRM (6-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=250,239,118,113,132,126	3.04 Titer
MenACWY-CRM (6-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 1), N=253,238,119,114,134,124	2.04 Titer
MenACWY-PS (6-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=250,239,118,113,132,126	2.56 Titer
MenACWY-PS (6-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 360), N=249,237,119,113,130,124	4.95 Titer
MenACWY-PS (6-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 1), N=249,237,119,113,130,124	3.43 Titer
MenACWY-PS (6-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 1), N=253,238,119,114,134,124	2 Titer
MenACWY-PS (6-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 1), N=252,240,119,114,133,126	2.38 Titer
MenACWY-PS (6-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 360), N=252,240,119,114,133,126	4.71 Titer
MenACWY-PS (6-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 360), N=250,239,118,113,132,126	3.42 Titer
MenACWY-PS (6-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 360), N=253,238,119114,134,124	2.49 Titer
MenACWY-CRM (6-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 360), N=250,239,118,113,132,126	30 Titer
MenACWY-CRM (6-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 1), N=253,238,119,114,134,124	2.09 Titer
MenACWY-CRM (6-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 1), N=249,237,119,113,130,124	6.75 Titer
MenACWY-CRM (6-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 360), N=249,237,119,113,130,124	49 Titer
MenACWY-CRM (6-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=250,239,118,113,132,126	3.53 Titer
MenACWY-CRM (6-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 360), N=253,238,119114,134,124	4.66 Titer
MenACWY-CRM (6-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 1), N=252,240,119,114,133,126	3.3 Titer
MenACWY-CRM (6-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 360), N=252,240,119,114,133,126	15 Titer
MenACWY-PS (6-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 360), N=250,239,118,113,132,126	7.82 Titer
MenACWY-PS (6-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 1), N=249,237,119,113,130,124	8.1 Titer
MenACWY-PS (6-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 1), N=252,240,119,114,133,126	4.77 Titer
MenACWY-PS (6-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 360), N=252,240,119,114,133,126	16 Titer
MenACWY-PS (6-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 360), N=249,237,119,113,130,124	11 Titer
MenACWY-PS (6-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 360), N=253,238,119114,134,124	3.55 Titer
MenACWY-PS (6-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=250,239,118,113,132,126	4.39 Titer
MenACWY-PS (6-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 1), N=253,238,119,114,134,124	2.04 Titer

Secondary

hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine

hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or the licensed MenACWY-PS vaccine.

Time frame: 1 month post vaccination (Day 29)

Population: Analysis was done on per protocol population.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 1), N=280, 281	2.06 Titers
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 29), N=280, 281	36 Titers
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 1)	3.07 Titers
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 29)	26 Titers
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 1), N=279, 282	5.74 Titers
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 29), N=279, 282	60 Titers
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=280, 282	3.32 Titers
MenACWY-CRM (2-10 Years Old)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 29), N=280, 282	54 Titers
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 29), N=280, 282	11 Titers
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 1), N=280, 281	2.02 Titers
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 1), N=279, 282	5.63 Titers
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 29), N=280, 281	6.31 Titers
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=280, 282	3.34 Titers
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 1)	3.33 Titers
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 29), N=279, 282	14 Titers
MenACWY-PS (2-10 Years)	hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 29)	15 Titers

Secondary

hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine

hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-5 years of age and 6-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or licensed MenACWY-PS vaccine.

Time frame: 1 month post vaccination (Day 29)

Population: Analysis was done on per protocol population.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
MenACWY-CRM (2-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=134,138,146,144	3 Titer
MenACWY-CRM (2-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 29), N=134,138,146,144	42 Titer
MenACWY-CRM (2-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 1), N=133,138,147,143	2.04 Titer
MenACWY-CRM (2-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 29), N=133,138,147,143	28 Titer
MenACWY-CRM (2-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 1), N=135,138,146,145	2.81 Titer
MenACWY-CRM (2-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 29), N=135,138,146,145	14 Titer
MenACWY-CRM (2-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 1), N=135,138,144,144	4.68 Titer
MenACWY-CRM (2-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 29), N=135,138,144,144	43 Titer
MenACWY-PS (2-10 Years)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 29), N=135,138,146,145	6.93 Titer
MenACWY-PS (2-10 Years)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 1), N=135,138,146,145	2.38 Titer
MenACWY-PS (2-10 Years)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 29), N=134,138,146,144	7.17 Titer
MenACWY-PS (2-10 Years)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 29), N=135,138,144,144	7.84 Titer
MenACWY-PS (2-10 Years)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 1), N=135,138,144,144	3.64 Titer
MenACWY-PS (2-10 Years)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 29), N=133,138,147,143	5.8 Titer
MenACWY-PS (2-10 Years)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 1), N=133,138,147,143	2 Titer
MenACWY-PS (2-10 Years)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=134,138,146,144	2.57 Titer
MenACWY-CRM (6-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 1), N=135,138,144,144	6.94 Titer
MenACWY-CRM (6-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 1), N=133,138,147,143	2.08 Titer
MenACWY-CRM (6-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 29), N=133,138,147,143	45 Titer
MenACWY-CRM (6-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 1), N=135,138,146,145	3.33 Titer
MenACWY-CRM (6-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 29), N=135,138,146,145	47 Titer
MenACWY-CRM (6-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 29), N=135,138,144,144	80 Titer
MenACWY-CRM (6-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=134,138,146,144	3.65 Titer
MenACWY-CRM (6-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 29), N=134,138,146,144	68 Titer
MenACWY-PS (6-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 1), N=133,138,147,143	2.03 Titer
MenACWY-PS (6-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 29), N=133,138,147,143	6.84 Titer
MenACWY-PS (6-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 29), N=134,138,146,144	18 Titer
MenACWY-PS (6-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=134,138,146,144	4.3 Titer
MenACWY-PS (6-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 1), N=135,138,146,145	4.58 Titer
MenACWY-PS (6-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 29), N=135,138,144,144	24 Titer
MenACWY-PS (6-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 1), N=135,138,144,144	8.55 Titer
MenACWY-PS (6-10 Years Old)	hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 29), N=135,138,146,145	33 Titer

Secondary

Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine

Number of subjects (2-10 years, 2-5 years and 6-10 years old subjects) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, 12 months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.

Time frame: 12 months post vaccination (Day 360)

Population: Analysis was done on per protocol population.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM (2-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 1), N=252,240,119,114,133,126	70 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 360), N=253,238,119,114,134,124	71 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 1), N=253,238,119,114,134,124	6 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 360), N=252,240,119,114,133,126	172 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 1), N=249,237,119,113,130,124	96 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 360), N=249,237,119,113,130,124	234 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=250,239,118,113,132,126	53 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 360), N=250,239,118,113,132,126	215 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 360), N=252,240,119,114,133,126	126 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 360), N=250,239,118,113,132,126	90 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 1), N=253,238,119,114,134,124	1 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=250,239,118,113,132,126	59 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 360), N=249,237,119,113,130,124	119 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 1), N=252,240,119,114,133,126	72 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 360), N=253,238,119,114,134,124	44 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 1), N=249,237,119,113,130,124	85 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 360), N=253,238,119,114,134,124	27 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 1), N=252,240,119,114,133,126	26 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 360), N=252,240,119,114,133,126	77 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 360), N=250,239,118,113,132,126	101 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 1), N=249,237,119,113,130,124	35 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 360), N=249,237,119,113,130,124	108 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=250,239,118,113,132,126	22 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 1), N=253,238,119,114,134,124	2 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=250,239,118,113,132,126	14 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 360), N=249,237,119,113,130,124	41 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 1), N=249,237,119,113,130,124	21 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 1), N=253,238,119,114,134,124	0 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 1), N=252,240,119,114,133,126	12 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 360), N=252,240,119,114,133,126	41 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 360), N=250,239,118,113,132,126	26 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 360), N=253,238,119,114,134,124	15 Subjects
MenACWY-CRM (6-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 360), N=250,239,118,113,132,126	114 Subjects
MenACWY-CRM (6-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 1), N=253,238,119,114,134,124	4 Subjects
MenACWY-CRM (6-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 1), N=249,237,119,113,130,124	61 Subjects
MenACWY-CRM (6-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 360), N=249,237,119,113,130,124	126 Subjects
MenACWY-CRM (6-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=250,239,118,113,132,126	31 Subjects
MenACWY-CRM (6-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 360), N=253,238,119,114,134,124	44 Subjects
MenACWY-CRM (6-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 1), N=252,240,119,114,133,126	44 Subjects
MenACWY-CRM (6-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 360), N=252,240,119,114,133,126	95 Subjects
MenACWY-PS (6-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 360), N=250,239,118,113,132,126	64 Subjects
MenACWY-PS (6-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 1), N=249,237,119,113,130,124	64 Subjects
MenACWY-PS (6-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 1), N=252,240,119,114,133,126	60 Subjects
MenACWY-PS (6-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup C (Day 360), N=252,240,119,114,133,126	85 Subjects
MenACWY-PS (6-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup W (Day 360), N=249,237,119,113,130,124	78 Subjects
MenACWY-PS (6-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 360), N=253,238,119,114,134,124	29 Subjects
MenACWY-PS (6-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=250,239,118,113,132,126	45 Subjects
MenACWY-PS (6-10 Years)	Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine	Serogroup A (Day 1), N=253,238,119,114,134,124	1 Subjects

Secondary

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years

Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.

Time frame: Day 1 to 7 post vaccination

Population: Analysis was done on safety population i.e. all randomized subjects who received a vaccination and who had follow up safety data.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Local reactions	56 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Change in eating habits, N=145,150	18 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Malaise, N=156, 157	NA Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Nausea, N=156, 157	NA Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Chills, N=156, 157	NA Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Sleepiness	25 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Myalgia, N=156, 157	NA Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Analg./antipyr. med. used, N=150,152,157,157	38 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Other	40 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Irritability	29 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Injection site pain	43 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Injection site erythema	23 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Stayed at home due to reactions, N=146,151,154,156	6 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Vomiting	12 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Systemic reactions	55 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Injection site induration	17 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Headache, N=151,153,156,157	6 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Diarrhea	11 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Arthralgia, N=151,153,156,157	3 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Diarrhea	6 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Arthralgia, N=151,153,156,157	7 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Chills, N=156, 157	NA Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Stayed at home due to reactions, N=146,151,154,156	5 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Nausea, N=156, 157	NA Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Myalgia, N=156, 157	NA Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Malaise, N=156, 157	NA Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Injection site induration	5 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Systemic reactions	45 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Injection site pain	30 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Change in eating habits, N=145,150	16 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Local reactions	37 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Other	31 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Sleepiness	24 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Irritability	26 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Headache, N=151,153,156,157	3 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Vomiting	6 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Injection site erythema	11 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Analg./antipyr. med. used, N=150,152,157,157	28 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Other	37 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Local reactions	70 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Injection site pain	57 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Injection site erythema	26 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Injection site induration	26 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Systemic reactions	39 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Change in eating habits, N=145,150	NA Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Sleepiness	NA Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Irritability	NA Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Vomiting	NA Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Diarrhea	NA Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Chills, N=156, 157	13 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Nausea, N=156, 157	6 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Malaise, N=156, 157	12 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Myalgia, N=156, 157	12 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Arthralgia, N=151,153,156,157	5 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Headache, N=151,153,156,157	29 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Stayed at home due to reactions, N=146,151,154,156	6 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Analg./antipyr. med. used, N=150,152,157,157	36 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Diarrhea	NA Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Injection site pain	43 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Arthralgia, N=151,153,156,157	3 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Vomiting	NA Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Irritability	NA Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Local reactions	50 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Headache, N=151,153,156,157	17 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Sleepiness	NA Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Change in eating habits, N=145,150	NA Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Systemic reactions	28 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Other	23 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Injection site induration	6 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Injection site erythema	9 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Analg./antipyr. med. used, N=150,152,157,157	23 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Malaise, N=156, 157	9 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Nausea, N=156, 157	6 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Stayed at home due to reactions, N=146,151,154,156	3 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Myalgia, N=156, 157	4 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years	Chills, N=156, 157	5 Subjects

Secondary

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months

Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.

Time frame: Day 1 to 7 post vaccination

Population: Analysis was done on safety population.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Sleepiness	22 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Persistent crying, N=74,70,71,72	1 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Analgesic/antipyretic medicine used	35 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Vomiting	1 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Irritability	36 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Injection site reaction erythema	29 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Local reactions	37 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Injection site reaction induration	16 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Other	35 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Systemic reactions	47 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Injection site reaction tenderness	15 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Change in eating habits, N=74,70,71,72	11 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Diarrhea	10 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Diarrhea	11 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Local reactions	29 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Vomiting	2 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Injection site reaction induration	13 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Persistent crying, N=74,70,71,72	3 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Analgesic/antipyretic medicine used	44 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Sleepiness	32 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Change in eating habits, N=74,70,71,72	20 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Irritability	40 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Systemic reactions	50 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Injection site reaction erythema	17 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Injection site reaction tenderness	17 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Other	44 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Diarrhea	20 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Local reactions	40 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Injection site reaction tenderness	19 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Injection site reaction erythema	30 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Injection site reaction induration	16 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Systemic reactions	51 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Change in eating habits, N=74,70,71,72	13 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Sleepiness	21 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Persistent crying, N=74,70,71,72	4 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Irritability	33 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Vomiting	4 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Other	25 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Analgesic/antipyretic medicine used	25 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Local reactions	35 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Vomiting	5 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Change in eating habits, N=74,70,71,72	18 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Systemic reactions	50 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Diarrhea	16 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Injection site reaction induration	10 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Injection site reaction erythema	25 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Analgesic/antipyretic medicine used	41 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Other	41 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Injection site reaction tenderness	18 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Irritability	32 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Persistent crying, N=74,70,71,72	4 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Sleepiness	25 Subjects

Secondary

Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years

Time frame: Day 1- Day 360 (throughout the study)

Population: Analysis was done on safety population.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years	Possibly or probably related AEs	6 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years	AEs leading to premature withdrawal	0 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years	SAEs	2 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years	Any AE	56 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years	Possibly or probably related AEs	7 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years	AEs leading to premature withdrawal	0 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years	Any AE	43 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years	SAEs	1 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years	SAEs	0 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years	AEs leading to premature withdrawal	0 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years	Any AE	45 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years	Possibly or probably related AEs	15 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years	AEs leading to premature withdrawal	0 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years	Any AE	33 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years	SAEs	0 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years	Possibly or probably related AEs	9 Subjects

Secondary

Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months

Time frame: Day 1- Day 360 (Throughout the study)

Population: Analysis was done on safety population.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Any AE	35 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Possibly or probably related AEs	6 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	AEs leading to premature withdrawal	0 Subjects
MenACWY-CRM (2-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	SAEs	2 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Possibly or probably related AEs	1 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	AEs leading to premature withdrawal	0 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	SAEs	3 Subjects
MenACWY-PS (2-10 Years)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Any AE	33 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	AEs leading to premature withdrawal	0 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Possibly or probably related AEs	1 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	SAEs	3 Subjects
MenACWY-CRM (6-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Any AE	25 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	SAEs	2 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Possibly or probably related AEs	4 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	Any AE	30 Subjects
MenACWY-PS (6-10 Years Old)	Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months	AEs leading to premature withdrawal	1 Subjects

Secondary

Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine

Percentage of subjects (12-23 months old) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y after receiving one dose of MenACWY-CRM vaccine compared with percentage of subjects (3-5 years old) with hSBA ≥ 1:4 after one dose of licensed MenACWY-PS vaccine.

Time frame: 1 month post vaccination (Day 29)

Population: Analysis was done on per protocol population.

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM (2-10 Years Old)	Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine	Serogroup A (Day 1), N=240,91	0 Percentages of subjects
MenACWY-CRM (2-10 Years Old)	Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine	Serogroup A (Day 29), N=240,91	81 Percentages of subjects
MenACWY-CRM (2-10 Years Old)	Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine	Serogroup C (Day 1), N=241,91	3 Percentages of subjects
MenACWY-CRM (2-10 Years Old)	Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine	Serogroup C (Day 29), N=241,91	90 Percentages of subjects
MenACWY-CRM (2-10 Years Old)	Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine	Serogroup W (Day 1), N=240,91	3 Percentages of subjects
MenACWY-CRM (2-10 Years Old)	Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine	Serogroup W (Day 29), N=240,91	86 Percentages of subjects
MenACWY-CRM (2-10 Years Old)	Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine	Serogroup Y (Day 1), N=238,91	2 Percentages of subjects
MenACWY-CRM (2-10 Years Old)	Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine	Serogroup Y (Day 29), N=238,91	64 Percentages of subjects
MenACWY-PS (2-10 Years)	Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine	Serogroup Y (Day 29), N=238,91	51 Percentages of subjects
MenACWY-PS (2-10 Years)	Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine	Serogroup A (Day 1), N=240,91	0 Percentages of subjects
MenACWY-PS (2-10 Years)	Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine	Serogroup W (Day 1), N=240,91	24 Percentages of subjects
MenACWY-PS (2-10 Years)	Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine	Serogroup A (Day 29), N=240,91	51 Percentages of subjects
MenACWY-PS (2-10 Years)	Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine	Serogroup Y (Day 1), N=238,91	15 Percentages of subjects
MenACWY-PS (2-10 Years)	Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine	Serogroup C (Day 1), N=241,91	12 Percentages of subjects
MenACWY-PS (2-10 Years)	Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine	Serogroup W (Day 29), N=240,91	63 Percentages of subjects
MenACWY-PS (2-10 Years)	Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine	Serogroup C (Day 29), N=241,91	42 Percentages of subjects

Secondary

Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine

Percentages of subjects (2-5 years of age and 6-10 years of age) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.

Time frame: 1 month post vaccination (Day 29)

Population: Analysis was done on per protocol population. The total number of participants analyzed in the MenACWY-CRM (2-10 Years Old) group (282), is different respect with that reported in the Outcome Measure 1 (281). There, the largest number for each group across the 4 strains was reported (not all strains had a result from the lab-i.e. C strain).

Arm	Measure	Group	Value (NUMBER)
MenACWY-CRM (2-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup A (Day 1), N=133,138,147,143	2 Percentages of subjects
MenACWY-CRM (2-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup A (Day 29), N=133,138,147,143	80 Percentages of subjects
MenACWY-CRM (2-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup C (Day 1), N=135,138,146,145	23 Percentages of subjects
MenACWY-CRM (2-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup C (Day 29), N=135,138,146,145	76 Percentages of subjects
MenACWY-CRM (2-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup W (Day 1), N=135,138,144,144	32 Percentages of subjects
MenACWY-CRM (2-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup W (Day 29), N=135,138,144,144	90 Percentages of subjects
MenACWY-CRM (2-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=134,138,146,144	18 Percentages of subjects
MenACWY-CRM (2-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup Y (Day 29), N=134,138,146,144	87 Percentages of subjects
MenACWY-PS (2-10 Years)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup W (Day 29), N=135,138,144,144	55 Percentages of subjects
MenACWY-PS (2-10 Years)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup W (Day 1), N=135,138,144,144	22 Percentages of subjects
MenACWY-PS (2-10 Years)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup A (Day 29), N=133,138,147,143	43 Percentages of subjects
MenACWY-PS (2-10 Years)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup Y (Day 29), N=134,138,146,144	49 Percentages of subjects
MenACWY-PS (2-10 Years)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=134,138,146,144	13 Percentages of subjects
MenACWY-PS (2-10 Years)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup C (Day 29), N=135,138,146,145	45 Percentages of subjects
MenACWY-PS (2-10 Years)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup C (Day 1), N=135,138,146,145	11 Percentages of subjects
MenACWY-PS (2-10 Years)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup A (Day 1), N=133,138,147,143	0 Percentages of subjects
MenACWY-CRM (6-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=134,138,146,144	25 Percentages of subjects
MenACWY-CRM (6-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup C (Day 1), N=135,138,146,145	34 Percentages of subjects
MenACWY-CRM (6-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup C (Day 29), N=135,138,146,145	88 Percentages of subjects
MenACWY-CRM (6-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup W (Day 1), N=135,138,144,144	47 Percentages of subjects
MenACWY-CRM (6-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup W (Day 29), N=135,138,144,144	98 Percentages of subjects
MenACWY-CRM (6-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup Y (Day 29), N=134,138,146,144	95 Percentages of subjects
MenACWY-CRM (6-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup A (Day 1), N=133,138,147,143	3 Percentages of subjects
MenACWY-CRM (6-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup A (Day 29), N=133,138,147,143	83 Percentages of subjects
MenACWY-PS (6-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup C (Day 1), N=135,138,146,145	46 Percentages of subjects
MenACWY-PS (6-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup C (Day 29), N=135,138,146,145	82 Percentages of subjects
MenACWY-PS (6-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup A (Day 29), N=133,138,147,143	46 Percentages of subjects
MenACWY-PS (6-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup A (Day 1), N=133,138,147,143	1 Percentages of subjects
MenACWY-PS (6-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup W (Day 1), N=135,138,144,144	53 Percentages of subjects
MenACWY-PS (6-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup Y (Day 29), N=134,138,146,144	69 Percentages of subjects
MenACWY-PS (6-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup Y (Day 1), N=134,138,146,144	35 Percentages of subjects
MenACWY-PS (6-10 Years Old)	Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine	Serogroup W (Day 29), N=135,138,144,144	88 Percentages of subjects

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026

Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine

hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine

hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine

hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine

hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine

Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months

Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years

Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months

Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine

Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine