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

NCT01086969 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2012-02-06

Study results available
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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®.

Conditions

Interventions

BIOLOGICAL

Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)

0.5 mL, Intramuscular

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Sanofi Pasteur SA.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-02-28
Completion
2011-06-30

Countries

  • India

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01086969 on ClinicalTrials.gov