Clinical Trials/NCT01086969

NCT01086969

Completed

Phase 3

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

Sanofi0 sites300 target enrollmentJune 2010

ConditionsMeningococcal Infection Meningitis

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Meningococcal Infection
Sponsor: Sanofi
Enrollment: 300
Primary Endpoint: Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

June 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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

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