Sanofi: FDA Okays Quadracel DTaP-IPV Vaccine For Children

(RTTNews) - Sanofi Pasteur, the vaccines unit of Sanofi (SNY), on Wednesday said the U.S. Food and Drug Administration has approved the use of Quadracel vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children aged between 4 and 6 years.

The FDA approval is based on data from a Phase III study that compared the safety and immunogenicity of Quadracel vaccine with Daptacel and IPOL vaccines in children 4 through 6 years of age who were previously vaccinated with Daptacel and/or Pentacel vaccines.

Results show Quadracel vaccine has similar safety and immunogenicity profiles as compared to those of separately administered Daptacel and IPOL vaccines.