NCT00384397

A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers

An Immunogenicity and Safety Evaluation of Two Doses of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) Given to Healthy Subjects at 9 and 12 Months of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,128 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 249 Days – 305 Days
• Healthy volunteers: Accepted

Summary

This is a Phase III, modified single-blind, randomized, parallel-group, multicenter, comparative trial in the United States designed to evaluate the immunogenicity and safety of two doses of Menactra vaccine administered alone, and concomitantly with other routine pediatric vaccines typically administered between 12 and 15 months of age. Primary Objective: To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135. Secondary Objectives: Immunogenicity * To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with Hib and MMRV vaccines. * To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with PCV vaccine. Safety \- To describe the safety profile within 7 and 30 days of each vaccination, and serious adverse events (SAEs) throughout the course of the study.

Conditions

• Meningococcal Meningitis
• Measles
• Mumps
• Rubella
• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine	0.5 mL, Intramuscular
BIOLOGICAL	Meningococcal Polysaccharide Diphtheria Toxoid Conjugate	0.5 mL, Intramuscular
BIOLOGICAL	Meningococcal Polysaccharide Diphtheria Toxoid Conjugate	0.5 mL, Intramuscular

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-08-01
• Completion: 2009-02-01
• First posted: 2006-10-06
• Last updated: 2016-04-14
• Results posted: 2011-06-02

Locations

39 sites across 1 country: United States