Concomitant administration of a bivalent Haemophilus influenzae type b-hepatitis B vaccine, measles-mumps-rubella vaccine and varicella vaccine:: safety, tolerability and immunogenicity
Concomitant administration of a bivalent Haemophilus influenzae type b-hepatitis B vaccine, measles-mumps-rubella vaccine and varicella vaccine:: safety, tolerability and immunogenicity
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DOI：
10.1097/01.inf.0000114902.84651.02
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发表时间：
2004-03-01
影响因子：
3.6
通讯作者：
West, DJ
中科院分区：
文献类型：
--
作者：
Hesley, TM;Reisinger, KS;West, DJ
背景资料。本研究旨在验证双价乙型流感嗜血杆菌疫苗(Comvax)、麻疹-腮腺炎-风疹疫苗(M-M-R-II)和水痘疫苗(Varivax)联合接种对所有疫苗抗原具有良好的耐受性和适当的免疫原性。我们随机选择822名12至15个月大的健康儿童(1：1)同时注射Comvax、M-M-RI和Varivax(伴随组)或6周后注射M-M-R-II和Varivax(非伴随组)。在接种前和接种后6周采集血样，检测所有疫苗抗原抗体。疫苗接种总体上耐受性良好。同期和非同期治疗组的儿童在主要兴趣的安全终点方面相似(分别有16.1%和19.5%的儿童在两次就诊后14天内的任何时间发烧超过或等于华氏103度)。报告了15起严重不良事件(伴发组8例，非伴发组7例)；均已解决。两种严重不良事件(发烧、发烧和麻疹样皮疹；均发生在伴发组儿童中)的因素被认为可能与接种疫苗有关。一名儿童因后来被判定与疫苗接种无关的非严重不良事件而退出研究。相伴组和无相伴组的接种者对流感嗜血杆菌多糖、多聚核糖核糖醇磷酸(97.8%~98.7%)、乙肝表面抗原(99.2%~100%)、麻疹病毒(99.4%~99.6%)、流行性腮腺炎病毒(98.4%~99.2%)、风疹病毒(100%)和水痘病毒(93.2%~94.6%)均有满意的抗体应答。在12个月或15个月的诊所就诊时同时给予Comvax、M-M-RI和VARIVAX是一种令人满意的方式，可以在第二年提供所示的多种疫苗中的一些。
Background. The study was done to verify that concomitant administration of a bivalent Haemophilus influenzae type b-hepatitis B vaccine (Comvax), measles-mumps-rubella vaccine (M-M-R-II) and varicella vaccine (Varivax) would be well-tolerated and suitably immunogenic with respect to all vaccine antigens.Methods. We randomized 822 healthy 12- to 15-month-old children (1:1) to receive concomitant injections of Comvax, M-M-RI, and Varivax (concomitant group) or Comvax followed 6 weeks later by injections of M-M-R-II and Varivax (nonconcomitant group). Blood samples taken before and 6 weeks after vaccination were tested for antibodies to all vaccine antigens.Results. Vaccinations were generally well-tolerated. Children in the concomitant and nonconcomitant treatment groups were similar with respect to the safety endpoint of primary interest (16.1 and 19.5%, respectively, had a fever greater than or equal to103degreesF rectally at any time within 14 days after either of two clinic visits). Fifteen serious adverse events were reported (eight in the concomitant group and seven in the nonconcomitant group); all resolved. Elements of two serious adverse events (fever, fever and measles-like rash; both in concomitant group children) were considered possibly related to vaccination. One child was withdrawn from the study because of a nonserious adverse event subsequently judged to be unrelated to vaccination. Similar proportions of vaccinees in the concomitant and nonconcomitant groups developed satisfactory antibody responses to the H. influenzae polysaccharide, polyribosylribitol phosphate (97.8 to 98.7%), hepatitis B surface antigen (99.2 to 100%), measles virus (99.4 to 99.6%), mumps virus (98.4 to 99.2%), rubella virus (100%) and varicella virus (93.2 to 94.6%).Conclusion. Concomitant administration of Comvax, M-M-RI, and VARIVAX at the 12- or 15-month clinic visit is one satisfactory way of delivering some of the multiple vaccines indicated during the second year of life.