Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers

Phase 3 Completed 1378 enrolled Sanofi Pasteur, a Sanofi Company

Non-randomizedParallel-groupOpen-labelPrevention

Summary

This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US. Safety Objective: To describe the safety profile of two doses of Menactra® Vaccine.

Timeline

Start: 2007-05
Primary completion: 2009-01
Completion: 2009-04

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Menactra	Vaccine	0.5 ml	Intramuscular
Background	Hepatitis A	Vaccine	0.5 ml	Intramuscular
Background	Measles-mumps-rubella-varicella vaccine	Vaccine	0.5 ml	Intramuscular
Background	Pneumococcal conjugate (PCV)	Unknown	0.5 ml	Intramuscular

Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers

Summary

Timeline

Drugs

Indications