Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers

Phase 3

Completed

• Conditions: Rubella; Meningococcal Meningitis; Mumps; Measles; Varicella
• Interventions: Biological: Measles, Mumps, Rubella and Varicella; Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine

• Registration Number: NCT00422292
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers.

Primary Objectives:

* To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella (MMRV) vaccine when administered alone or concomitantly with Menactra vaccine.

* To evaluate the antibody responses induced by Pneumococcal Conjugated Vaccine (PCV) when administered alone or concomitantly with Menactra vaccine.

Observational Objectives:

Safety - To describe the safety profile throughout the course of the study from Day 0 up to 6 months after the last study vaccination\[s\]) in subjects in the study groups.

Immunogenicity:

- To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days after the first and second Menactra vaccine administration in a subset of subjects in the first study group.

Detailed Description

No meningococcal vaccine is presently licensed for the population aged \< 2 years in the US, establishing the effectiveness of a quadrivalent polysaccharide conjugate vaccine against invasive meningococcal disease in children aged \< 2 years would address this important, currently unmet public health need.

At enrollment, each 9-month old subject will be randomly assigned to a study group and vaccinated. A second vaccination will be administered at 12 months of age. Subjects will provide one blood sample during the trial.

Twelve-month old subjects will also be vaccinated with routine pediatric vaccines and provide one blood sample 30 days after vaccinations in the control group

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-01-12
• Study First Submitted QC: 2007-01-12
• Study First Posted: 2007-01-15
• Primary Completion: 2009-01
• Study Completion: 2009-04
• Disposition First Submitted: 2010-03-31
• Disposition First Submitted QC: 2010-03-31
• Disposition First Posted: 2010-04-02
• Results First Submitted: 2011-05-10
• Results First Submitted QC: 2011-05-10
• Results First Posted: 2011-06-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1664

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MMRV + PCV at 12 Months	Measles, Mumps, Rubella and Varicella	Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Menactra® at 9 and 12 Months	Meningococcal Polysaccharide Diphtheria Conjugate Vaccine	Participants will received Menactra® vaccination at 9 and 12 months of age.
Menactra® at 9 Months and Menactra® + MMRV at 12 Months	Meningococcal Polysaccharide Diphtheria Conjugate Vaccine	Participants will receive Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV) vaccine at 12 months of age
Menactra® at 9 Months and Menactra® + PCV at 12 Months	Meningococcal Polysaccharide Diphtheria Conjugate Vaccine	Participants will receive Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age

Primary Outcome Measures

Name	Time	Method
Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4	Day 30 after the 12-month vaccination
Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only)	Day 30 after the 12-month vaccination	Percentage of participants who had a concentration of ≥ 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or ≥ 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; ≥ 500 U/mL (ELISA) or ≥ 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; ≥ 10 IU/mL (ELISA) - for Rubella; and ≥ 300 mIU/mL (ELISA) or ≥ 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentration was less than 300 mIU/mL - for varicella.