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

Phase 3

Completed

• Conditions: Meningococcal Infection; Meningitis

• 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

Primary Outcome Measures

Name	Time	Method
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.
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.
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