010-84476011
环球医学>> 医学新闻>> 儿科>>正文内容
儿科

FDA批准新型二联疫苗Menhibrix

来源:环球医学编译    时间:2012年06月15日    点击数:    5星

6月15日消息 - 环球医学据悉,美国食品和药物管理局于当地时间6月14日批准了一种联合疫苗——Menhibrix用于6周至18个月大的婴幼儿,以预防脑膜炎奈瑟菌抗血清C群和Y群以及b型流感嗜血杆菌引起的侵袭性疾病。

脑膜炎奈瑟菌引起的疾病(脑膜炎球菌病)和b型流感嗜血杆菌引起的疾病(Hib病)可危及生命。这些细菌可感染血液,引起脓毒血症,并感染包裹大脑和脊髓的内层,导致脑膜炎。脑膜炎奈瑟菌和b型流感嗜血杆菌是导致幼儿细菌性脑膜炎的重要原因。

未接种疫苗的2岁以下儿童易感染这些严重的疾病。脑膜炎球菌病和Hib病特别危险,因为这两种疾病往往进展迅速,并可导致死亡或严重的长期健康后果,如失明、智力低下或截肢。这两种疾病的早期症状往往是很难与其他常见小儿疾病鉴别。

“随着Menhibrix于今天获得批准,现在我们有了一种联合疫苗可以用于儿童预防潜在危及生命的Hib病及2种脑膜炎球菌病。这是首个婴儿年仅6周就可接种的脑膜炎疫苗,”FDA生物制品评价与研究中心主任、医学博士、Karen Midthun说。

Menhibrix的有效性是基于美国几百例婴幼儿接种该疫苗后出现的免疫应答。在该疫苗的Hib方面,接种Menhibrix后的婴幼儿的免疫应答与接种FDA批准用于预防侵袭性Hib病的疫苗者的免疫应答相近。

在脑膜炎方面,研究结果表明,该疫苗在血液中产生的抗体水平预计将可保护婴幼儿免遭脑膜炎奈瑟菌抗血清C群和Y群引起的侵袭性脑膜炎球菌病。

Menhibrix在美国、墨西哥和澳大利亚的7500名婴幼儿中进行了安全性评价。接种Menhibrix后常见的不良反应是是注射部位疼痛红肿、烦躁和发热。

Menhibrix在婴幼儿2、4、6和12个月时连续接种4次。首次接种最早可在6周大时进行,而末次接种最迟可在18个月大时接种。

menhibrix是由总部位于比利时Rixensart的葛兰素史克生物制品公司制造。(环球医学)

原文:

FDA approves new combination vaccine that protects children against two bacterial diseases

The U.S. Food and Drug Administration today approved Menhibrix, a combination vaccine for infants and children ages 6 weeks through 18 months, for prevention of invasive disease caused by Neisseria meningitidis serogroups C and Yand Haemophilus influenzae type b.
Diseases caused by the bacteria Neisseria meningitidis (meningococcal disease) and Haemophilus influenzae type b (Hib disease) can be life-threatening. These bacteria can infect the bloodstream causing sepsis, and the lining that surrounds the brain and spinal cord causing meningitis. In young children, Neisseria meningitidis and Haemophilus influenzae type b are important causes of bacterial meningitis.

Without vaccination, children younger than two years are susceptible to these serious illnesses. Meningococcal and Hib diseases are particularly dangerous because both diseases often progress rapidly and can cause death or serious, long-lasting health consequences such as blindness, mental retardation, or amputations. Early symptoms for both diseases often are difficult to distinguish from other common childhood illnesses.

“With today’s approval of Menhibrix, there is now a combination vaccine that can be used to prevent potentially life-threatening Hib disease and two types of meningococcal disease in children. It is the first meningococcal vaccine that can be given starting as young as six weeks of age,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

The effectiveness of Menhibrix was based on immune responses in several hundred U.S. infants and toddlers vaccinated with Menhibrix. For the Hib component of the vaccine, immune responses in infants and toddlers following vaccination with Menhibrix were comparable to immune responses in infants and toddlers who received an FDA-approved vaccine against invasive Hib disease.

For the meningococcal component, study results showed that the vaccine produces antibodies in the blood at levels that are considered to be predictive of protection against invasive meningococcal disease caused by serogroups C and Y.

The safety of Menhibrix was evaluated in about 7,500 infants and toddlers in the U.S., Mexico and Australia. Common adverse reactions reported after administration of Menhibrix were pain, redness and swelling at the injection site, irritability and fever.

Menhibrix is given as a four-dose series at 2, 4, 6 and 12 through 15 months of age. The first dose may be given as early as 6 weeks of age. The fourth dose may be given as late as 18 months of age.

Menhibrix is manufactured by GlaxoSmithKline Biologicals, based in Rixensart, Belgium.

 

相关链接:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm308350.htm

 

版权声明:本文系环球医学独家稿件,版权为环球医学所有。欢迎转载,请务必注明出处(环球医学网),否则必将追究法律责任。

评价此内容
 我要打分

现在注册

联系我们

热点文章

  • 还没有任何项目!

最新会议

    [err:标签'新首页会议列表标签'查询数据库时出现异常。有关错误的完整说明,请到后台日志管理中查看“异常记录”]