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

Phase 3

Completed

• Conditions: Meningococcal Infection; Meningitis
• Interventions: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)

• Registration Number: NCT01086969
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study First Submitted: 2010-03-11
• Study First Submitted QC: 2010-03-12
• Study First Posted: 2010-03-15
• Study Start: 2010-06
• Primary Completion: 2011-02
• Study Completion: 2011-06
• Results First Submitted: 2012-01-03
• Results First Submitted QC: 2012-01-03
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-02
• Results First Posted: 2012-02-03
• Last Update Posted: 2012-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)	Participants in three age cohorts - Children: 2 - 11 years of age; Adolescents: 12 - 17 years of age, and Adults: 18 - 55 years of age will be enrolled.

Primary Outcome Measures

Name	Time	Method
Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination	Day 0 and Day 30 post-vaccination	Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.
Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination	Baseline and 21 days post-vaccination	Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test.
Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination	Day 0 to 30 post-vaccination	Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination	Day 0 to 7 post-vaccination	Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia