NCT01086969

A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India

Safety and Immunogenicity Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Healthy Subjects 2-55 Years of Age in India

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 2 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and immunogenicity of a single dose of Menactra® vaccine to support registration. Primary Objectives: * To describe the antibody titers measured by serum bactericidal activity using baby rabbit complement (SBA-BR) before and after Menactra® vaccination. * To describe the safety profile of participants after one dose of Menactra®.

Detailed description

Participants will be enrolled in three age cohorts: Children: 2 - 11 years of age; Adolescents: 12 - 17 years of age, and Adults: 18 - 55 years of age to receive a single dose of Menactra®. They will be followed for a duration of 30 days after vaccination.

Conditions

• Meningococcal Infection
• Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)	0.5 mL, Intramuscular

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-02-01
• Completion: 2011-06-01
• First posted: 2010-03-15
• Last updated: 2012-02-06
• Results posted: 2012-02-03

Locations

3 sites across 1 country: India