NCT00483574

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

Safety Study of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) When Administered With Other Pediatric Vaccines to Healthy Toddlers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,378 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 9 Months – 12 Months
• Healthy volunteers: Accepted

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.

Conditions

• Meningococcal Meningitis
• Measles
• Mumps
• Rubella
• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate	0.5 mL, IM at age 9 and 12 months
BIOLOGICAL	Measles-mumps-rubella-varicella vaccine	0.5 mL, intramuscular at 12 months of age
BIOLOGICAL	Routine paediatric vaccine - Pneumococcal conjugate (PCV)	0.5 mL, Intramuscular at age 12 months
BIOLOGICAL	Routine paediatric vaccine - Hepatitis A	0.5 mL, Intramuscular at age 12 months

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-01-01
• Completion: 2009-04-01
• First posted: 2007-06-07
• Last updated: 2016-05-16
• Results posted: 2011-07-06

Locations

79 sites across 2 countries: United States, Chile