2015年3月26日訊 /生物谷BIOON/ --法國製藥巨頭賽諾菲(Sanofi)旗下疫苗事業部賽諾菲巴斯德(Sanofi Pasteur)近日宣布，FDA已批准四聯疫苗Quadracel（吸附無細胞百白破-滅活脊髓灰質炎，DTaP-IPV）用於4-6歲兒童的主動免疫，預防嚴重威脅健康的4大疾病：百日咳、白喉、破傷風、脊髓灰質炎。
賽諾菲巴斯德美國科學和醫療事務部副總裁David P. Greenberg醫師表示，Quadracel此次獲FDA批准，為醫療保健機構提供了一種新的聯合疫苗，將潛在減少4-6歲兒童疫苗注射次數。
為保護嬰兒和兒童免受這幾種嚴重威脅健康的疾病，美國疾病控制和預防中心（CDC）推薦4-6歲兒童接種第5針百白破（DTaP）疫苗系列以及第4針滅活脊髓灰質炎病毒（IPV）疫苗系列。Quadracel疫苗可用於DTaP系列的第5針接種及IPV系列的第4或第5針。（附件：美國疾病控制和預防中心（CDC）發布的2015年美國《0-18歲人群免疫接種建議》）
Quadracel的獲批，是基於一項關鍵性多中心隨機對照III期研究的數據，該研究在此前已接種DAPTACEL和/或Pentacel（DTaP-IPV/Hib）的4-6歲兒童中開展，比較了Quadracel疫苗（DTaP-IPV）與DAPTACEL（DTaP）聯合IPOL（IPV）疫苗的免疫原性和安全性。結果表明，Quadracel疫苗與分別單獨接種DAPTACEL及IPOL疫苗具有相似的安全性及免疫原性。（生物谷Bioon.com）
CDC：Recommended Immunization Schedule for Persons Aged 0 Through 18 Years in United States, 2015
英文原文：FDA approves Quadracel vaccine to protect young children from life-threatening diseases
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.
About Quadracel Vaccine
Indication
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).