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FDA to review pediatric hexavalent vaccine

October 21, 2014

The FDA has accepted for review a Biologics License Application filed by Merck and Sanofi Pasteur for a pediatric hexavalent combination vaccine containing DTaP, inactivated poliovirus, Haemophilus influenzae type B and hepatitis B vaccines, according to a company press release.

The application acceptance is based on phase 3 study data, presented at IDWeek 2014 in Philadelphia, which indicated vaccine safety and immunogenicity among infants.


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