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REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-old Children

NCT00447525 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 760

Last updated 2017-09-11

No results posted yet for this study

Summary

Primary objective:

To demonstrate the non inferiority between REVAXIS® and DT Polio® when given as a second booster to healthy 6 year-old children .

Secondary objectives:

* Additional immunogenicity assessments.
* To describe the safety profile of a single dose of REVAXIS® or DT-Polio®

Conditions

  • Diphtheria
  • Tetanus
  • Poliomyelitis

Interventions

BIOLOGICAL

REVAXIS®

BIOLOGICAL

DT-Polio®

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • France

Study Locations

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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 NCT00447525 on ClinicalTrials.gov