A quadrivalent vaccine has been approved for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis in children aged 4-6 years in the United States, the manufacturer, Sanofi Pasteur, announced March 25.
The approved indication is for use in children in this age group “as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series, and as a fourth or fifth dose in the inactivated poliovirus vaccination (IPV) series, in children who have received 4 doses of Pentacel and/or Daptacel vaccine,” according to the prescribing information. The vaccine will be marketed as Quadracel (diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated Poliovirus).
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Pentacel (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and haemophilus b conjugate [tetanus toxoid conjugate]) and Daptacel (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) also are manufactured by Sanofi Pasteur.
The company statement announcing approval of Quadracel said that the Food and Drug Administration approval is based on a phase III randomized controlled study of children aged 4-6 years who had been vaccinated with the Daptacel and/or Pentacel vaccines. The study compared the safety and immunogenicity of the Quadracel vaccine with Daptacel (DTaP) and IPOL (IPV) and determined that the safety and immunogenicity profiles were similar, according to the company.
Another DTaP-IPV vaccine, Kinrix (diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine), was approved in 2008.