Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine

• Sponsor: Novartis Vaccines (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01345721
• Collaborator: (none)
• Enrollment: 205
• Locations: 11
• Arms: 3
• Duration (Months): 4
• Patients Per Site: 18.6
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

The primary purpose of this study is to evaluate the persistence of bactericidal antibodies in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study (NCT00667602) who received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine. This is measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against Neisseria meningitidis serogroups A, C, W-135, and Y. In addition the response one month post an additional dose of Novartis MenACWY will be measured by percentage of subjects with hSBA titers ≥ 1:8 and GMTs.

Condition or Disease	Intervention/Treatment	Phase
Meningococcal Disease	Biological: MenACWY-CRM	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 205 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Phase IIIb, Open-Label, Controlled, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MenACWY (2 primary + 1 booster dose) Subjects who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	Biological: MenACWY-CRM
Experimental: MenACWY (1 primary + 1 booster dose) Subjects who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	Biological: MenACWY-CRM
Experimental: MenC (1 primary dose)+MenACWY (1 booster dose) Subjects who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.	Biological: MenACWY-CRM

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine [From 13-33 months post last vaccination in parent study (V59P22)]

   The percentage of subjects with persisting serum bactericidal antibody (hSBA)titers ≥1:8 against Neisseria meningitidis serogroups A,C,W,Y, 13-33 months after receiving either one or two doses of MenACWY-CRM conjugate vaccine or one dose of MenC vaccine in parent study, is reported. The functional bactericidal antibodies response against N. meningitidis serogroups was measured with the serum bactericidal assay using human complement (hSBA)

2. Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination [1 month post booster]

   The serum antibody response following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y.

3. Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination [1 month post booster vaccination]

   The serum antibody titers following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, are reported as geometric mean titers (GMTs) against N. meningitidis serogroups A,C, W,Y.

4. Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination [1 month after vaccination]

   The serum antibody response following a dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C, W,Y

5. Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine [1 month post vaccination]

   The serum antibody titers following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C,W,Y

Secondary Outcome Measures

1. Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine [From 13-33 months post last vaccination in parent study (V59P22)]

   The persisting serum bactericidal antibody titers in children, 13-33 months after receiving either one or two doses of MenACWY-CRM vaccine or one dose of Men C vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y

2. Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine [1 month post vaccination]

   Comparison of serum antibody responses following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of Men C vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y

3. Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine [1 month post vaccination]

   Comparison of serum antibody titers following a one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y

4. Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination [Day 1-7 after vaccination]

   The safety and tolerability of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting solicited local and systemic AEs after MenACWY-CRM vaccine.

5. Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination [Day 1-28 after vaccination]

   The safety of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting any unsolicited AEs (day 1 to day 7); serious AEs and AEs necessitating medical attention/or premature withdrawal (day 1 to day 28) after MenACWY-CRM vaccine.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Months to 45 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Children eligible to be enrolled in the study were those

• whose parents provide written informed consent;

• were in generally good health based on the clinical judgment of the investigators;

• subjects were 22-45 months of age at the time of enrollment into V59P22E1;

• subject who had participated in the parent V59P22 study.

Exclusion Criteria:

Main exclusion criteria:

• Subjects with serious, acute, or chronic illnesses

• Subjects who had received any other licensed vaccines within 28 days (Exception: Influenza vaccine was allowed up to 14 days prior to and no less than 14 days after the study immunization) prior to enrolment and any study visit

• Subjects who had received any Meningococcal vaccine since the study dose of MenACWY or Men C at 12 months of age in V59P22 trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Johannes Kandzora and Dr. Kathrin Kandzora	Am Teich 11, Neumuenster		Germany	24534
2	Bogda-Maria Kniese,	Boyneburgstr 7, Eschwege		Germany	37269
3	Dr Goertz Martin Kimmig	GroBbottwarer Str 47, Oberstenfeld		Germany	71720
4	Dr med Walter Otto	Heinrichstrasse 16 A, Fulda		Germany	36037
5	Dr med Kerstin Pscherer	Hellersdorfer Str 237, Berlin		Germany	12627
6	Dr Renate Mangelsdorf-Taxis	Kirchstrasse 2, Bonnigheim		Germany	74357
7	Dr. Christoph Wittermann	Murnauer Str 3, Weilheim		Germany	82362
8	Ute Jessat	Rathausstr 6, Gluecksburg		Germany	24960
9	Dr med Luise Schroeter	Schoenwalder Str 28, Berlin		Germany	13347
10	Dr med Ulrich Pfletschinger	Stuttgarter Strasse 74, Stuttgart Feuerbach		Germany	70469
11	Dr Lothar Maurer	Welschgasse 39, Frankenthal		Germany	67227

Sponsors and Collaborators

• Novartis Vaccines

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Vaccines
• ClinicalTrials.gov Identifier: NCT01345721
• Other Study ID Numbers: V59P22E1
• First Posted: May 2, 2011
• Last Update Posted: Jun 18, 2018
• Last Verified: May 1, 2018

• Keywords provided by Novartis Vaccines: Meningococcal; ACWY; Conjugate Vaccine; Meningitis; Toddlers; Children; Persistence; Boost
• Additional relevant MeSH terms: Meningococcal Infections

Study Results

Participant Flow

Recruitment Details	Subjects for this extension study were enrolled from only sites in Germany that participated in the parent study.
Pre-assignment Detail	All enrolled subjects were included in the trial.

Arm/Group Title	MenACWY (2 Primary + 1 Booster Dose)	MenACWY (1 Primary + 1 Booster Dose)	MenC (1 Primary Dose) + MenACWY (1 Booster Dose)
Arm/Group Description	Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Period Title: Overall Study
STARTED	74	66	65
COMPLETED	74	66	65
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	MenACWY (2 Primary +1 Booster Dose)	MenACWY (1 Primary + 1 Booster Dose)	MenC (1 Primary Dose) +MenACWY (1 Booster Dose)	Total
Arm/Group Description	Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.	Total of all reporting groups
Overall Participants	74	66	65	205
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	36.7 (5.3)	37.4 (5.6)	37.9 (5.3)	37.3 (5.4)
Sex: Female, Male (Count of Participants)
Female	34 45.9%	30 45.5%	37 56.9%	101 49.3%
Male	40 54.1%	36 54.5%	28 43.1%	104 50.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine
Description	The percentage of subjects with persisting serum bactericidal antibody (hSBA)titers ≥1:8 against Neisseria meningitidis serogroups A,C,W,Y, 13-33 months after receiving either one or two doses of MenACWY-CRM conjugate vaccine or one dose of MenC vaccine in parent study, is reported. The functional bactericidal antibodies response against N. meningitidis serogroups was measured with the serum bactericidal assay using human complement (hSBA)
Time Frame	From 13-33 months post last vaccination in parent study (V59P22)

Outcome Measure Data

Analysis Population Description

The analysis was done on the per-protocol persistence dataset i.e all enrolled subjects who provided evaluable serum samples at day 1 of the study and had no major protocol violation as defined prior to the end of the study.

Arm/Group Title	MenACWY (2 Primary + 1 Booster Dose)	MenACWY (1 Primary + 1 Booster Dose)	MenC (1 Primary Dose) +MenACWY (1 Booster Dose)
Arm/Group Description	Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Measure Participants	52	41	43
13-33 months persistence (Serogroup A)	13	7	0
13-33 months persistence (Serogroup C)(N=52,40,42)	27	25	36
13-33 months persistence (Serogroup W-135)	50	63	12
13-33 months persistence (Serogroup Y)	40	39	19

2. Secondary Outcome

Title	Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine
Description	The persisting serum bactericidal antibody titers in children, 13-33 months after receiving either one or two doses of MenACWY-CRM vaccine or one dose of Men C vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y
Time Frame	From 13-33 months post last vaccination in parent study (V59P22)

Outcome Measure Data

Analysis Population Description

The analysis was done on the per-protocol persistence dataset.

Arm/Group Title	MenACWY (2 Primary + 1 Booster Dose)	MenACWY (1 Primary + 1 Booster Dose)	MenC (1 Primary Dose) + MenACWY (1 Booster Dose)
Arm/Group Description	Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Measure Participants	52	41	43
13-33 months persistence (Serogroup A)	2.82	2.52	2
13-33 months persistence (Serogroup C) N=52,40	3.94	3.93	4.94
13-33 months persistence (Serogroup W-135)	9.36	12	2.81
13-33 months persistence (Serogroup Y)	6.79	6.03	2.99

3. Primary Outcome

Title	Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination
Description	The serum antibody response following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y.
Time Frame	1 month post booster

Outcome Measure Data

Analysis Population Description

The analysis was done on the per-protocol dataset i.e All enrolled subjects who correctly received the vaccine, provided evaluable serum samples at the relevant time points (Day 28),and had no major protocol violation as defined prior to the end of the study.

Arm/Group Title	MenACWY (2 Primary + 1 Booster Dose)	MenACWY (1 Primary + 1 Booster Dose)
Arm/Group Description	Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
Measure Participants	52	41
Pre-booster (Serogroup A)	13	7
1 month post booster (Serogroup A)	96	98
Pre-booster (Serogroup C) N=52,40	27	25
1 month post booster (Serogroup C) N=52,40	100	100
Pre-booster (Serogroup W-135)	50	63
1 month post booster (Serogroup W-135)	100	100
Pre-booster (Serogroup Y)	40	39
1 month post booster (Serogroup Y)	100	100

4. Primary Outcome

Title	Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination
Description	The serum antibody titers following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, are reported as geometric mean titers (GMTs) against N. meningitidis serogroups A,C, W,Y.
Time Frame	1 month post booster vaccination

Outcome Measure Data

Analysis Population Description

The analysis was done on the per-protocol dataset.

Arm/Group Title	MenACWY (2 Primary + 1 Booster Dose)	MenACWY (1 Primary + 1 Booster Dose)
Arm/Group Description	Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
Measure Participants	52	41
Pre-booster (Serogroup A)	2.82	2.52
1 month post booster (Serogroup A)	182	214
Pre-booster (Serogroup C) N=52,40	3.92	3.91
1 month post booster (Serogroup C) N=52,40	541	968
Pre-booster (Serogroup W-135)	9.37	12
1 month post booster (Serogroup W-135)	799	1267
Pre-booster (Serogroup Y)	6.79	6.04
1 month post booster (Serogroup Y)	650	676

5. Primary Outcome

Title	Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination
Description	The serum antibody response following a dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C, W,Y
Time Frame	1 month after vaccination

Outcome Measure Data

Analysis Population Description

The analysis was done on the per-protocol dataset.

Arm/Group Title	MenC (1 Primary Dose) +MenACWY (1 Booster Dose)
Arm/Group Description	Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Measure Participants	41
Pre-vaccination (Serogroup A)	0
1 month post vaccination (Serogroup A)	61
Pre-vaccination (Serogroup C) N=39	36
1 month post vaccination (Serogroup C) N=39	100
Pre-vaccination (Serogroup W-135)	12
1 month post vaccination (Serogroup W-135)	95
Pre-vaccination (Serogroup Y)	20
1 month post vaccination (Serogroup Y)	95

6. Primary Outcome

Title	Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine
Description	The serum antibody titers following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C,W,Y
Time Frame	1 month post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was done on the per-protocol dataset.

Arm/Group Title	MenC (1 Primary Dose) +MenACWY (1 Booster Dose)
Arm/Group Description	Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Measure Participants	41
Pre-vaccination (Serogroup A)	2
1 month post vaccination (Serogroup A)	20
Pre-vaccination (Serogroup C) N=39	4.83
1 month post vaccination (Serogroup C) N=39	1530
Pre-vaccination (Serogroup W-135)	2.82
1 month post vaccination (Serogroup W-135)	54
Pre-vaccination (Serogroup Y)	3.05
1 month post vaccination (Serogroup Y)	54

7. Secondary Outcome

Title	Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine
Description	Comparison of serum antibody responses following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of Men C vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y
Time Frame	1 month post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was done on the per-protocol dataset

Arm/Group Title	MenACWY (1 Primary + 1 Booster Dose)	MenC (1 Primary Dose) +MenACWY (1 Booster Dose)
Arm/Group Description	Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study	Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study
Measure Participants	41	41
hSBA ≥1:8(Serogroup A)	98	61
hSBA ≥1:8 (Serogroup C) N=40,39	100	100
hSBA ≥1:8(Serogroup W-135)	100	95
hSBA ≥1:8 (Serogroup Y)	100	95

8. Secondary Outcome

Title	Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine
Description	Comparison of serum antibody titers following a one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y
Time Frame	1 month post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was done on the per-protocol dataset

Arm/Group Title	MenACWY (1 Primary + 1 Booster Dose)	MenC (1 Primary Dose) +MenACWY (1 Booster Dose)
Arm/Group Description	Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study	Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study
Measure Participants	41	41
1 month post vaccination (Serogroup A)	214	20
1 month post vaccination (Serogroup C) N=40,39	968	1530
1 month post vaccination (Serogroup W-135)	1267	54
1 month post vaccination (Serogroup Y)	676	54

9. Secondary Outcome

Title	Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination
Description	The safety and tolerability of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting solicited local and systemic AEs after MenACWY-CRM vaccine.
Time Frame	Day 1-7 after vaccination

Outcome Measure Data

Analysis Population Description

The analysis was done on the safety dataset i.e all subjects who received the study vaccine and provided some post-vaccination safety data

Arm/Group Title	MenACWY (2 Primary + 1 Booster Dose)	MenACWY (1 Primary + 1 Booster Dose)	MenC (1 Primary Dose) + MenACWY (1 Booster Dose)
Arm/Group Description	Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Measure Participants	53	44	43
Any Solicited Local	33 44.6%	30 45.5%	30 46.2%
Injection site pain	10 13.5%	15 22.7%	13 20%
Injection site erythema	14 18.9%	17 25.8%	15 23.1%
Injection site induration	6 8.1%	8 12.1%	7 10.8%
Any Solicited Systemic	28 37.8%	18 27.3%	25 38.5%
Arthralgia	1 1.4%	5 7.6%	4 6.2%
Headache	5 6.8%	6 9.1%	1 1.5%
Vomiting	0 0%	2 3%	1 1.5%
Change in eating habits	6 8.1%	8 12.1%	6 9.2%
Rash	0 0%	2 3%	1 1.5%
Sleepiness	10 13.5%	13 19.7%	10 15.4%
Fever (≥38°C)	8 10.8%	7 10.6%	7 10.8%
Any other	5 6.8%	7 10.6%	5 7.7%
Stayed at home	4 5.4%	5 7.6%	2 3.1%
Analgesic Antipyretic Medication Used	4 5.4%	6 9.1%	5 7.7%
Temperature (≥40°C) (N= 52,41,41)	0 0%	0 0%	2 3.1%

10. Secondary Outcome

Title	Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination
Description	The safety of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting any unsolicited AEs (day 1 to day 7); serious AEs and AEs necessitating medical attention/or premature withdrawal (day 1 to day 28) after MenACWY-CRM vaccine.
Time Frame	Day 1-28 after vaccination

Outcome Measure Data

Analysis Population Description

The analysis was done on the safety dataset.

Arm/Group Title	MenACWY (2 Primary + 1 Booster Dose)	MenACWY (1 Primary + 1 Booster Dose)	MenC (1 Primary Dose) + MenACWY (1 Booster Dose)
Arm/Group Description	Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.	Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
Measure Participants	53	44	43
Any AE	11 14.9%	10 15.2%	9 13.8%
At least possibly related AEs	0 0%	2 3%	1 1.5%
Serious AE	0 0%	0 0%	0 0%
AEs leading to premature withdrawal	0 0%	0 0%	0 0%
Deaths	0 0%	0 0%	0 0%

Adverse Events

Time Frame	Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28.
Adverse Event Reporting Description	Due to non-compliance with protocol, data from one site was excluded in the parent study and subsequently from this extension study.Thus the number of subjects analyzed for safety differ from enrolled population.
Arm/Group Title	MenACWY (2 Primary + 1 Booster Dose)		MenACWY (1 Primary + 1 Booster Dose)		MenC (1 Primary Dose) + MenACWY (1 Booster Dose)
Arm/Group Description	Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.		Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.		Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
All Cause Mortality
	MenACWY (2 Primary + 1 Booster Dose)		MenACWY (1 Primary + 1 Booster Dose)		MenC (1 Primary Dose) + MenACWY (1 Booster Dose)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	MenACWY (2 Primary + 1 Booster Dose)		MenACWY (1 Primary + 1 Booster Dose)		MenC (1 Primary Dose) + MenACWY (1 Booster Dose)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/44 (0%)		0/43 (0%)
Other (Not Including Serious) Adverse Events
	MenACWY (2 Primary + 1 Booster Dose)		MenACWY (1 Primary + 1 Booster Dose)		MenC (1 Primary Dose) + MenACWY (1 Booster Dose)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/53 (62.3%)		31/44 (70.5%)		30/43 (69.8%)
Gastrointestinal disorders
Diarrhoea	4/53 (7.5%)		2/44 (4.5%)		8/43 (18.6%)
General disorders
Injection site erythema	14/53 (26.4%)		17/44 (38.6%)		15/43 (34.9%)
Injection site induration	6/53 (11.3%)		8/44 (18.2%)		7/43 (16.3%)
Injection site pain	10/53 (18.9%)		15/44 (34.1%)		13/43 (30.2%)
Irritability	12/53 (22.6%)		8/44 (18.2%)		14/43 (32.6%)
Pyrexia	8/53 (15.1%)		8/44 (18.2%)		7/43 (16.3%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/53 (1.9%)		5/44 (11.4%)		4/43 (9.3%)
Nervous system disorders
Headache	5/53 (9.4%)		6/44 (13.6%)		1/43 (2.3%)
Somnolence	10/53 (18.9%)		13/44 (29.5%)		10/43 (23.3%)
Psychiatric disorders
Eating disorder	6/53 (11.3%)		8/44 (18.2%)		6/43 (14%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.