Sanofi Pasteur announced that the Food and Drug Administration (FDA) has approved Quadracel (diphtheria and tetanus toxoids and acellular pertussis absorbed and inactivated poliovirus [DTaP-IPV]) vaccine for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis in children ages 4–6 years.

Quadracel is indicated for use 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 four doses of Pentacel (diphtheria and tetanus toxoids + acellular pertussis adsorbed + inactivated poliovirus vaccine (susp); Hib conjugate (tetanus toxoid conjugate, PRP) and/or Daptacel (diphtheria and tetanus toxoids, acellular pertussis vaccine; Sanofi Pasteur).

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The approval of Quadracel vaccine was based on data from a Phase 3 multi-center, randomized, controlled study that compared the safety and immunogenicity of Quadracel vaccine with Daptacel and Ipol (trivalent poliovirus vaccine; inactivated; Sanofi Pasteur) vaccines in children ages 4–6 years who were previously vaccinated with Daptacel and/or Pentacel (DTaP-IPV/Hib) vaccines. Study results showed Quadracel vaccine had similar safety and immunogenicity profiles compared to those of separately administered Daptacel and Ipol vaccines.

Quadracel is available in in a single-dose vial in 10-count packs.

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