Study Comparing a Tdap-IPV Combined Vaccine With a Tetanus Monovalent Vaccine in Healthy Adults

Phase 3 Completed 52 enrolled Sanofi Pasteur, a Sanofi Company

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to demonstrate that a combined adult Tdap-IPV vaccine (REPEVAX®) will provide similar rapid antibody responses against tetanus toxoid as a tetanus toxoid vaccine alone in healthy adults.

Timeline

Start: 2009-07
Primary completion: 2009-12
Completion: 2009-12

Outcome

Met primary endpoint

paper All participants receiving Tdap-IPV and 99.0% receiving TMV had an anti-tetanus antibody concentration ≥ 0.1 IU/mL, confirming non-inferiority of Tdap-IPV to TMV (95% confidence interval of the difference: -1.2, 3.6). PMID 23032160 ↗

Publications

Laurichesse H, Zimmermann U, Galtier F, Launay O, Duval X, Richard P, Sadorge C, Soubeyrand B. Immunogenicity and safety results from a randomized multicenter trial comparing a Tdap-IPV vaccine (REPEVAX(R)) and a tetanus monovalent vaccine in healthy adults: new considerations for the management of patients with tetanus-prone injuries. Hum Vaccin Immunother. 2012 Dec 1;8(12):1875-81. doi: 10.4161/hv.22083. Epub 2012 Oct 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Monovalent Tetanus vaccine	Vaccine	0.5 ml	—
Subject	REPEVAX	Vaccine	0.5 ml	—

Indications

No indication recorded.