NCT00422292

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

An Immunogenicity, Safety, and Non-Interference Evaluation of Pediatric Vaccines Administered Concomitantly With Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) to Healthy Toddlers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,664 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 9 Months – 12 Months
• Healthy volunteers: Accepted

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

Conditions

• Meningococcal Meningitis
• Measles
• Mumps
• Rubella
• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal Polysaccharide Diphtheria Conjugate Vaccine	0.5 mL dose, intramuscular (IM)
BIOLOGICAL	Meningococcal Polysaccharide Diphtheria Conjugate Vaccine	0.5 mL dose, IM
BIOLOGICAL	Meningococcal Polysaccharide Diphtheria Conjugate Vaccine	0.5 Ml dose, IM
BIOLOGICAL	Measles, Mumps, Rubella and Varicella	0.5 mL dose, SC

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-01-01
• Completion: 2009-04-01
• First posted: 2007-01-15
• Last updated: 2016-04-14
• Results posted: 2011-06-02

Locations

88 sites across 2 countries: United States, Puerto Rico