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FDA approves Sanofi Pasteur’s Quadracel vaccine for children four to six years of age

Vaccines division Sanofi Pasteur has secured approval from the US Food and Drug Administration (FDA) to use Quadracel vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children four through six years of age.

The approval is based on data from a pivotal multicenter, randomized, controlled, Phase III trial designed to compare the safety and immunogenicity of Quadracel vaccine with DAPTACEL (DTaP) and IPOL (IPV) vaccines in these children who were previously vaccinated with DAPTACEL and/or Pentacel (DTaP-IPV/Hib) vaccines.

Results from this trial show that Quadracel vaccine has similar safety and immunogenicity profiles as compared to those of separately administered DAPTACEL and IPOL vaccines.

Sanofi Pasteur vice president, US Scientific and Medical Affairs David Greenberg said: "The FDA approval of Quadracel vaccine provides health care providers with a new combination vaccine, potentially reducing the number of vaccine injections children aged 4 through 6 would need.

"Our goal is to help remove barriers to timely immunization and we think this combination vaccine could help ensure children are getting vaccinated in line with current recommendations."

The Centers for Disease Control and Prevention (CDC) has recommend both their fifth dose of the diphtheria, tetanus and acellular pertussis (DTaP) vaccine series and their fourth dose of inactivated poliovirus (IPV) vaccine series, in order to protect infants and children from life-threatening diseases.

The company said that Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV) vaccine can be administered as a fifth dose in the DTaP series and as a fourth or fifth dose in the IPV series in these children.