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

Phase 3 Completed 760 enrolled Sanofi Pasteur, a Sanofi Company

RandomizedParallel-groupOpen-labelPrevention

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®

Timeline

Start: 2007-02
Primary completion: 2008-01
Completion: 2008-01

Outcome

Met primary endpoint

paper Non-inferiority of REVAXIS compared with DT Polio for seroprotection was demonstrated against diphtheria (respectively 98.6% and 99.3%), tetanus (respectively 99.6% and 100%), and poliovirus antigens (100% for each types in both groups). PMID 21441781 ↗

Publications

Gajdos V, Soubeyrand B, Vidor E, Richard P, Boyer J, Sadorge C, Fiquet A. Immunogenicity and safety of combined adsorbed low-dose diphtheria, tetanus and inactivated poliovirus vaccine (REVAXIS ((R))) versus combined diphtheria, tetanus and inactivated poliovirus vaccine (DT Polio ((R))) given as a booster dose at 6 years of age. Hum Vaccin. 2011 May;7(5):549-56. doi: 10.4161/hv.7.5.14982. Epub 2011 May 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	DT-Polio®	Vaccine	—	Intramuscular
Subject	REVAXIS®	Vaccine	—	Intramuscular