FDA approves Quadracel vaccine for Diptheria, Tetanus, Pertussis and Polio- Sanofi
The FDA has approved use of Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV) vaccine, from Sanofi, for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children 4 through 6 years of age.
This FDA approval is based on data from a pivotal multicenter, randomized, controlled, Phase III study designed to compare the safety and immunogenicity of Quadracel vaccine (DTaP-IPV) with DAPTACEL (DTaP) and IPOL (IPV) vaccines in children 4 through 6 years of age who were previously vaccinated with DAPTACEL and/or Pentacel (DTaP-IPV/Hib) vaccines. Results show Quadracel vaccine has similar safety and immunogenicity profiles as compared to those of separately administered DAPTACEL and IPOL vaccines.
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