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US FDA licenses Sanofi Pasteur's new pediatric combination vaccine, pentacel
Date:6/23/2008

s 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® vaccine, pediatricians can reduce the number of vaccination shots while providing protection against five diseases, including pertussis."

Pentacel® 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®[a] vaccine, licensed in 2002) and its tetanus, diphtheria, and acellular pertussis (Tdap) vaccine for adults and adolescents (Adacel®[b] vaccine, licensed in 2005). Pertussis is commonly known as whooping cough because of the sound some patientsespecially childrenmake while gasping for air during coughing spells.

The FDA licensure of Pentacel® 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® vaccine. The immunogenicity of Pentacel® vaccine was compared to separately administered DAPTACEL, IPOL®[c] and ActHIB®[d] vaccines (studies P3T06 and M5A10), as well as to other single-entity vaccine formulations (study 494-01). The safety of Pentacel® vaccine was compared both to separately administered DAPTACEL, IPOL and ActHIB vaccines (study P3T06) and to other single-entity vaccine formulations (study 494-01).

In clinical studies, local and systemic reactions following administration of Pentacel® vaccine were reported at rates consistent with those of the separately administered vaccines used in each trial. The most common local and systemic adverse reactions to Pentacel® vac
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Contact: Len Lavenda
len.lavenda@sanofipasteur.com
570-839-4446
Publicis Consultants | PR
Source:Eurekalert

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