联合疫苗Menhibrix获准用于预防细菌性脑膜炎

圣路易斯(MD Consult)——2012年6月14日，美国食品药品管理局(FDA)与葛兰素史克宣布，Menhibrix疫苗已获准用于6周~18个月婴儿或儿童，预防由C/Y血清型脑膜炎奈瑟氏菌和乙型嗜血杆菌引起的侵袭性疾病。对于幼儿，脑膜炎奈瑟氏菌和乙型流感嗜血杆菌(Hib)是细菌性脑膜炎的重要病因。

FDA批准Menhibrix的依据包括7年来在美国、墨西哥、澳大利亚、比利时和德国开展的临床试验的数据，涉及7,521例接种了至少1剂Menhibrix的婴幼儿。根据数百名接种Menhibrix的美国婴幼儿的免疫应答指标确定该疫苗的效果。对于疫苗中的Hib成分，婴幼儿接种后的免疫应答情况，与接种FDA已批准的侵袭性Hib疾病疫苗后的应答相当。至于脑膜炎球菌成分，研究结果显示该疫苗诱导的血液抗体滴度足以预防C/Y血清型脑膜炎奈瑟氏菌导致的侵袭性疾病。

葛兰素史克公司称，脑膜炎奈瑟氏菌的血清型分布可能每年都不同，但美国的脑膜炎球菌疾病主要由B、C和Y血清型所致。目前美国尚无疫苗可以预防B血清型感染。

在临床试验中观察到的不良事件包括注射部位疼痛和红肿、易激惹、困倦和食欲不振。

婴幼儿需接种4次Menhibrix，接种时间为2个月、4个月、6个月和12~15个月。第1剂最早可在6周时接种，第4剂最迟可在18个月时接种。

爱思唯尔  版权所有

ST LOUIS (MD Consult) - On June 14, 2012, the US Food and Drug Administration (FDA) and GlaxoSmithKline announced the approval of the vaccine Menhibrix for the prevention of invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b in infants and children aged 6 weeks to 18 months. In young children, Neisseria meningitidis and Haemophilus influenzae type b (Hib) are important causes of bacterial meningitis.

The basis for the FDA approval of Menhibrix included data from clinical trials conducted in the United States, Mexico, Australia, Belgium, and Germany over 7 years in which 7521 infants and toddlers received at least 1 dose of Menhibrix. The effectiveness of Menhibrix was determined on the basis of immune-response measurements in several hundred US infants and toddlers vaccinated with Menhibrix. For the Hib component of the vaccine, immune responses in infants and toddlers after 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.

According to GlaxoSmithKline, serogroup distribution of Neisseria meningitidis may vary from year to year, but serogroups B, C, and Y cause most cases of meningococcal disease in the United States. The most common vaccine-preventable serogroups are C and Y. No vaccine is currently available in the United States to protect against serogroup B.

Adverse events in clinical trials included pain and redness at the injection site, irritability, drowsiness, and loss of appetite.

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