White C J, Stinson D, Staehle B, Cho I, Matthews H, Ngai A, Keller P, Eiden J, Kuter B
Department of Clinical Research, Merck Research Laboratories, West Point, Pennsylvania 19486, USA.
Clin Infect Dis. 1997 May;24(5):925-31. doi: 10.1093/clinids/24.5.925.
Eight hundred and twelve children, 12 months to 3.5 years of age, were enrolled in two clinical studies to evaluate the safety and immunogenicity of a live, attenuated combination vaccine for measles, mumps, rubella, and varicella (MMRV). Children were enrolled in one of two randomized, multicenter studies, involving administration of (1) MMRV and placebo vs. measles, mumps, and rubella vaccine (M-M-R(II)) and varicella-zoster virus vaccine (VARIVAX), given at separate anatomic sites at the same office visit; or (2) MMRV, DTaP (diphtheria, tetanus, and acellular pertussis vaccine) and OPV (oral polio vaccine) vs. M-M-R(II), DTaP, and OPV, with VARIVAX given 6 weeks later. All vaccine regimens were generally well tolerated. More than 95% of vaccinees seroconverted for measles, mumps, rubella, and varicella, regardless of the vaccine or regimen used. In each study, the level of antibody titer to varicella virus was significantly lower in vaccinees receiving MMRV than in those who received VARIVAX in a separate syringe.
812名年龄在12个月至3.5岁之间的儿童参与了两项临床研究,以评估一种麻疹、腮腺炎、风疹和水痘减毒活联合疫苗(MMRV)的安全性和免疫原性。儿童被纳入两项随机多中心研究之一,研究内容包括:(1)MMRV与安慰剂对比麻疹、腮腺炎和风疹疫苗(M-M-R(II))以及水痘-带状疱疹病毒疫苗(VARIVAX),在同一次门诊就诊时于不同解剖部位接种;或(2)MMRV、白百破疫苗(DTaP,白喉、破伤风和无细胞百日咳疫苗)和口服脊髓灰质炎疫苗(OPV)对比M-M-R(II)、DTaP和OPV,6周后接种VARIVAX。所有疫苗接种方案总体耐受性良好。无论使用何种疫苗或接种方案,超过95%的接种者对麻疹、腮腺炎、风疹和水痘产生了血清转化。在每项研究中,接种MMRV的接种者体内水痘病毒抗体滴度水平显著低于在不同注射器中接种VARIVAX的接种者。