Clinical Trials Directory

Trials / Completed

CompletedNCT00447525

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

Comparison of the Immunogenicity and Safety of a Combined Adsorbed Low Dose Diphtheria, Tetanus and Inactivated Poliomyelitis Vaccine (REVAXIS®) With a Combined Diphtheria, Tetanus and Inactivated Poliomyelitis Vaccine (DT Polio®) When Given as a Booster Dose at 6 Years of Age

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
760 (actual)
Sponsor
Sanofi Pasteur, a Sanofi Company · Industry
Sex
All
Age
6 Years – 6 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BIOLOGICALREVAXIS®
BIOLOGICALDT-Polio®

Timeline

Start date
2007-02-01
Primary completion
2008-01-01
Completion
2008-01-01
First posted
2007-03-14
Last updated
2017-09-11

Locations

64 sites across 1 country: France

Source: ClinicalTrials.gov record NCT00447525. Inclusion in this directory is not an endorsement.