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U.S. FDA Licenses Sanofi Pasteur's New Pediatric Combination Vaccine, Pentacel(R)
Date:6/23/2008

n this important step, to make the convenience of Pentacel(R) vaccine available to health-care providers and parents in the U.S.," Pisano added.

"The FDA approval of Pentacel(R) vaccine is great news for parents and pediatricians who want to reduce the stress of well-baby visits," said Tina Q. Tan, M.D., infectious disease specialist, Children's Memorial Hospital, Chicago. "Pertussis disease continues to remain a threat to young infants, who are at the highest risk for severe complications and death. With a four-dose primary series of Pentacel(R) vaccine, pediatricians can reduce the number of vaccination shots while providing protection against five diseases, including pertussis."

Pentacel(R) vaccine is also the first five-component (pentavalent) pediatric combination vaccine in the U.S. to contain sanofi pasteur's five acellular pertussis antigens, which are also used in its DTaP vaccine for children (DAPTACEL(R)(a) vaccine, licensed in 2002) and its tetanus, diphtheria, and acellular pertussis (Tdap) vaccine for adults and adolescents (Adacel(R)(b) vaccine, licensed in 2005). Pertussis is commonly known as whooping cough because of the sound some patients -- especially children -- make while gasping for air during coughing spells.

The FDA licensure of Pentacel(R) vaccine is based on the results of multi-center clinical studies conducted in the U.S. and Canada involving more than 5,000 children who received at least one dose of Pentacel(R) vaccine. The immunogenicity of Pentacel(R) vaccine was compared to separately administered DAPTACEL, IPOL(R)(c) and ActHIB(R)(d) vaccines (studies P3T06 and M5A10), as well as to other single-entity vaccine formulations (study 494-01). The safety of Pentacel(R) vaccine was compared both to separately administered DAPTACEL, IPOL and ActHIB vaccines (study P3T06) and to other single-entity vaccine formulations (study 494-01).

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SOURCE Sanofi Pasteur
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