默克制药（MRK），DTaP5-IPV-Hib-HepB1疫苗

StephenW

Merck (MRK), Sanofi (SNY) Report FDA Acceptance of DTaP5-IPV-Hib-HepB1 BLA
Merck (NYSE: MRK) and Sanofi Pasteur, the vaccines division of Sanofi (NYSE: SNY), announced today that the Biologics License Application (BLA) filed for the companies’ investigational pediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB1, has been accepted for review by the U.S. Food and Drug Administration (FDA). If approved, it would be the first pediatric combination vaccine in the United States designed to help protect against six important diseases – diphtheria, tetanus, pertussis (whooping cough), polio (poliovirus types 1, 2, and 3), invasive disease caused by Haemophilus influenzae type b (Hib), and hepatitis B.

“We are excited about reaching another key milestone in the development of this investigational pediatric vaccine against six important diseases,” said Robin Isaacs, M.D., Vice President, Vaccine Clinical Research, Merck Vaccines.

“Leading organizations – the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians – generally recommend the use of combination vaccines instead of individual injections,” said John Shiver, Ph.D., Senior Vice President, Research and Development, Sanofi Pasteur.

Phase III Clinical Study Data Presented at IDWeek

Data from a Phase III study for the investigational pediatric hexavalent vaccine were recently presented at IDWeek in Philadelphia. This Phase III study, a randomized, open-label, active-comparator controlled clinical trial with more than 1,400 infants at multiple centers across the United States, evaluated the safety and immunogenicity of the investigational pediatric hexavalent vaccine versus licensed comparator vaccines. The investigational and comparator vaccines were given at two, four, and six months of age.

In the study, healthy infants were randomized in a 2:1 ratio to receive either the investigational pediatric hexavalent vaccine (Group 1) or Sanofi Pasteur’s Pentacel® 2 plus Merck’s Recombivax HB® 3(Group 2). Antibody levels after the third infant doses were measured, and from these measurements 19 primary comparisons between Groups 1 and 2 were evaluated. For 18 of these 19 comparisons (all but one pertussis comparison), the antibodies in the Group 1 infants were non-inferior to those in the Group 2 infants. After the toddler dose of licensed vaccines, antibodies were again measured; the Group 1 antibodies were non-inferior to those in Group 2 for all 8 pertussis comparisons.

The most common, solicited, systemic adverse events following any dose of the investigational hexavalent vaccine were irritability (83%), crying (75%), and drowsiness (74%). Solicited systemic adverse event rates after any dose were similar following administration of the investigational pediatric hexavalent vaccine versus control with the exception of increased rates of fever, which was mostly mild to moderate in intensity and two days or fewer in duration.

“We are encouraged by the results of this Phase III trial,” said Gary S. Marshall, M.D., professor of pediatrics, University of Louisville School of Medicine, and lead investigator of the study. “This investigational combination vaccine against six important diseases showed similar immune responses against the antigens covered by licensed vaccines.”

The partnership between Merck and Sanofi Pasteur draws upon both companies' experience in the development, manufacturing and marketing of individual and combination vaccines. This pediatric hexavalent vaccine includes antigens for diphtheria, tetanus, pertussis (whooping cough), and polio (poliovirus types 1, 2, and 3) from Sanofi Pasteur and antigens for Haemophilus influenzae type b and hepatitis B from Merck.

默克制药（MRK），DTaP5-IPV-Hib疫苗，HepB1血乳酸赛诺菲（SNY）报告美国FDA验收
默克公司（纽约证券交易所代码：MRK）和赛诺菲 - 巴斯德，赛诺菲的疫苗事业部（纽约证券交易所代码：SNY）今天宣布，该生物制剂许可申请（BLA）申请的公司的研究性儿科六价疫苗，DTaP5-IPV-Hib疫苗，HepB1，有接受申请复审，由美国食品和药物管理局（FDA）。如果获得批准，这将是第一个儿童联合疫苗在美国，旨在帮助防止6重大疾病 - 白喉，破伤风，百日咳（百日咳），小儿麻痹症（脊髓灰质炎病毒1型，2，3），侵入性疾病引起的b型流感嗜血杆菌（Hib）和乙肝

“我们很高兴能达成预防六种重大疾病本研究用小儿疫苗发展的又一个重要里程碑，”罗宾·艾萨克斯，医学博士，副总裁，疫苗的临床研究，默克公司疫苗说。

“领导机构 - 免疫接种咨询委员会的做法，美国小儿科学院和家庭医生的美国学院 - 一般建议使用联合疫苗，而不是单独的注射，”约翰哆嗦，博士，高级副总裁，研究与发展，赛诺菲巴斯德。

在IDWeek III期临床研究数据提交

从第三阶段研究的研究性儿科六价疫苗的数据，最近发表在IDWeek在费城。这第三阶段的研究，一项随机，开放标签，活性药物对照的临床试验超过1400婴儿在全美国多中心，评估了研究性儿科六价疫苗与行货比较疫苗的安全性和免疫原性。试验用与比较器的疫苗在年龄二，四，六个月给予。

在这项研究中，健康的婴儿被随机分配在2：1的比例分别接受了研究性儿科六价疫苗（第1组）或赛诺菲巴斯德的Pentacel®2加默克的RecombivaxHB®3（第2组）。测定所获得的第三婴儿剂量后抗体水平，并从这些测量组1和组2之间19初级的比较进行评价。 18这19个对比（除了一个百日咳比较），在第1组婴儿的抗体是不逊色于那些在第2组的婴儿。批准上市的疫苗幼儿接种后，抗体，再次测量;在第1组的抗体是非劣于第2组的所有8百日咳比较。

最常见的，征求，全身不良以下试验用六价疫苗的任何剂量事件是烦躁不安（83％），哭了（75％），嗜睡（74％）。任何剂量后，征求了全身的不良事件发生率相似下面的研究性儿科六价疫苗对除发热率增加，这主要是轻度强度两天或更少的时间到中度的控制管理。

“我们对这一三期临床试验的结果感到鼓舞，”加里·马歇尔医师，儿科教授，医学学院路易斯维尔大学和研究的主要研究者说。 “预防六种疾病的重要研究用这种联合疫苗表现出对所涵盖的许可疫苗的抗原相似的免疫反应。”

默克和赛诺菲巴斯德公司之间的合作伙伴关系借鉴了两家公司在个人和联合疫苗的开发，制造和营销经验。这儿科六价疫苗包含抗原白喉，破伤风，百日咳（百日咳），和脊髓灰质炎（脊灰病毒1型，2，3）从赛诺菲巴斯德和抗原的流感嗜血杆菌b型和B型肝炎默克。

咬牙硬挺

预防性疫苗，看来几十年以后乙肝真要成为历史了