Sanofi Pasteur Announces FDA Approval of Quadracel DTaP-IPV Combination Vaccine for Children Aged 4-6

Approval allows children to receive a combination of two recommended vaccinations

SWIFTWATER, Pa., March 25, 2015 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has approved use of 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 4 through 6 years of age.

"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," said David P. Greenberg, M.D., Vice President, U.S. Scientific and Medical Affairs, Sanofi Pasteur. "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."

To protect infants and children from life-threatening diseases, the Centers for Disease Control and Prevention (CDC) recommend children 4 through 6 years of age receive both their fifth dose of the diphtheria, tetanus and acellular pertussis (DTaP) vaccine series and their fourth dose of inactivated poliovirus (IPV) vaccine series.1 Quadracel vaccine can be administered as a fifth dose in the DTaP series and as a fourth or fifth dose in the IPV series 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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About Quadracel Vaccine

Quadracel vaccine is given for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis. A single dose of Quadracel vaccine is approved for use in children 4 through 6 years of age 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® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate [Tetanus Toxoid Conjugate] Vaccine) and/or DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed).

Safety Information
Side effects of Quadracel vaccine may include pain, redness, and swelling at the injection site; muscle pain, fatigue, and headache. Other side effects may occur. Tell the doctor if your child has ever experienced a severe brain disorder, such as encephalopathy (altered consciousness), Guillain-Barré syndrome (severe muscle weakness), or if side effects occurred following a previous dose of pertussis-containing vaccine.
There is a small risk of allergic reactions. Some signs of allergic reactions are hives, swelling of the throat, low blood pressure, difficulty breathing, and shock. If your child begins experiencing any of these signs seek treatment right away. These reactions are rare and usually occur before leaving the doctor's office. If you notice any other problems or symptoms following vaccination, please contact your child's doctor promptly. Vaccination with Quadracel vaccine may not protect all children receiving the vaccine.