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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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 Summary: 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.
Sponsor: Sanofi

Current Primary Outcome:

  • Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 0 to 7 post-vaccination ]
    Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia


Original Primary Outcome:

  • To provide information concerning the immunogenicity in terms of the serum bactericidal activity using baby rabbit complement (SBA-BR) before and after Menactra® vaccination. [ Time Frame: 30 days post-vaccination ]
  • To provide information concerning the safety of Menactra® vaccine in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events. [ Time Frame: 0-30 days post-vaccination ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sanofi

Dates:
Date Received: March 11, 2010
Date Started: June 2010
Date Completion:
Last Updated: February 2, 2012
Last Verified: February 2012