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Safety and Immunogenicity Study for Use of Menactra® Versus Adacel® in Subjects 11 to 55 Years of Age in South Korea

NCT01642589 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2013-12-03

Study results available
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Summary

The aim of the study is to assess safety and immunogenicity of a single dose of Menactra® in support of registration of the vaccine in South Korea.

Primary Objective:

* To demonstrate that the seroconversion rate is higher than 60% for serogroups A, C, Y and W-135, 28 days after a single dose of Menactra®.

Secondary objectives:

* To demonstrate the superiority of Menactra® versus Adacel® in terms of seroconversion rate for serogroups A, C, Y, and W-135, 28 days after a single dose of vaccine
* To describe the safety profile after 1 dose of Menactra® or Adacel® vaccine.
* To describe the Serum Bactericidal Assay Using Baby Rabbit (SBA-BR) Complement titers before and 28 days after a single dose of Menactra® or Adacel® vaccine.

Conditions

Interventions

BIOLOGICAL

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)

0.5 mL, Intramuscular

BIOLOGICAL

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur SA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-01-31
Completion
2013-06-30

Countries

  • South Korea

Study Locations

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Entities

Diseases

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 NCT01642589 on ClinicalTrials.gov