March 25, 2015
Sanofi Pasteur announced today that the FDA has approved Quadracel, a DTaP and inactivated poliovirus vaccine, for use among children aged 4 through 6 years.
The approval is based on data from a multicenter, randomized, controlled phase 3 study that compared safety and efficacy of Quadracel vs. Daptacel (DTaP, Sanofi Pasteur) and Ipol (IPV, Sanofi Pasteur). Study participants had been previously vaccinated with DTaP or Pentacel (DTaP-IPV-Hib, Sanofi Pasteur). Results indicated Quadracel had similar immunogenicity and safety as Daptacel and Ipol vaccines.