NCT00643916

Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age

Safety and Immunogenicity of a Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine (TetraMenD) In Toddlers 9 to 18 Months of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 378 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 9 Months – 5 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age. Primary Objective: To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of one dose of Menomune® when administered to children aged 3 years to \<6 years of age.

Detailed description

This is a Phase II, open-label, parallel, exploratory, multi-center study in healthy toddlers.

Conditions

• Meningitis
• Meningococcal Infection

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)	0.5 mL, Intramuscular (at age 9 and 12 months)
BIOLOGICAL	Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)	0.5 mL, Intramuscular (at age 9 and 15 months)
BIOLOGICAL	Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)	0.5 mL, Intramuscular (at age 12 and 15 months)
BIOLOGICAL	Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)	0.5 mL, Intramuscular (at age 15 months)
BIOLOGICAL	Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)	0.5 mL, Intramuscular (at age 18 months)
BIOLOGICAL	A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)	0.5 mL, Subcutaneous (at 3 years to \<6 years of age)

Timeline

• Start date: 2004-12-01
• Primary completion: 2006-03-01
• Completion: 2007-10-01
• First posted: 2008-03-26
• Last updated: 2014-02-14
• Results posted: 2010-01-08

Locations

14 sites across 1 country: United States