Concomitant administration of hepatitis A vaccine with measles/mumps/rubella/varicella and pneumococcal vaccines in healthy 12-to 23-month-old children
Concomitant administration of hepatitis A vaccine with measles/mumps/rubella/varicella and pneumococcal vaccines in healthy 12-to 23-month-old children
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DOI：
10.4161/hv.24873
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发表时间：
2013-08-01
影响因子：
4.8
通讯作者：
Lee, Andrew W.
中科院分区：
文献类型：
--
作者：
Yetman, Robert J.;Shepard, Julie S.;Lee, Andrew W.
这项开放标签、多中心、随机化、比较研究评价了伴随使用的免疫原性、安全性和耐受性。（第1组; n = 330）vs.非伴随治疗（第2组; n = 323）VAQTA（25 U/0.5 mL）（甲型肝炎疫苗; HAV）与ProQuad（麻疹/腮腺炎/风疹/水痘; MMRV）和Prevnar（7价肺炎球菌; PCV-7）在健康的12-23个月大的儿童中进行比较。第1组在第1天同时接受HAV/MMRV/PCV-7，并在第24周接受第二剂HAV/MMRV。第2组在第1天接受MMRV/PCV-7，在第6周和第30周接受HAV，在第34周接受MMRV。甲型肝炎血清阳性率（SPR：10 mIU/mL;第2次给药后4周）、水痘带状疱疹病毒（VZV）SPR（5 gpELISA单位/mL）和对S. pneumoniae的检查。收集注射部位和全身不良事件（AE）和每日温度。两次HAV给药后，第1组和第2组的甲型肝炎SPR分别为100%和99.4%;无论初始血清状态如何，风险差异= 0.7（95%CI：-1.4，3.8，非劣效性）。第1组的VZV SPR为93.3%，第2组为98.3%;风险差异= -5.1（95%CI：-9.3，-1.4;非劣效性）。S.肺炎克雷伯氏菌GMT倍数差异（7种血清型）范围为0.9 - 1.1;非劣效性。当HAV伴随与非伴随给药时，未观察到个体AE发生率的统计学显著差异。11起严重AE中有3起（均为MMRV/PCV-7给药后第2组）被认为可能与疫苗相关：第52天脱水和胃肠炎（同一受试者）;第9天发热性惊厥。未报告死亡。每种疫苗同时接种的抗体应答均不劣于HAV与MMRV和PCV-7非同时接种。HAV与PCV-7和MMRV联合给药在12至23个月大的儿童中具有可接受的安全性。
This open-label, multicenter, randomized, comparative study evaluated immunogenicity, safety and tolerability of concomitant (Group 1; n = 330) vs. non-concomitant (Group 2; n = 323) VAQTA (25U/0.5 mL) (hepatitis A vaccine; HAV) with ProQuad (measles/mumps/rubella/varicella; MMRV) and Prevnar (7-valent pneumococcal; PCV-7) in healthy, 12-23 mo old children. Group 1 received HAV/MMRV/PCV-7 concomitantly on Day 1 and second doses of HAV/MMRV at Week 24. Group 2 received MMRV/PCV-7 on Day 1, HAV at Weeks 6 and 30 and MMRV at Week 34. Hepatitis A seropositivity rate (SPR: 10 mIU/mL; 4 weeks postdose 2), varicella zoster-virus (VZV) SPR (5 gpELISA units/mL) and geometric mean titers (GMT) to S. pneumoniae were examined. Injection-site and systemic adverse experiences (AEs) and daily temperatures were collected. Hepatitis A SPR were 100% for Group 1 and 99.4% for Group 2 after two HAV doses; risk difference = 0.7 (95%CI: -1.4,3.8, non-inferior) regardless of initial serostatus. VZV SPR was 93.3% for Group 1 and 98.3% for Group 2; risk difference = -5.1 (95%CI: -9.3, -1.4; non-inferior). S. pneumoniae GMT fold-difference (7 serotypes) ranged from 0.9 to 1.1; non-inferior. No statistically significant differences in the incidence of individual AEs were seen when HAV was administered concomitantly vs. non-concomitantly. Three (all Group 2 post-administration of MMRV/PCV-7) of 11 serious AEs were considered possibly vaccine-related: dehydration and gastroenteritis (same subject) on Day 52; febrile seizure on Day 9. No deaths were reported. Antibody responses to each vaccine given concomitantly were non-inferior to HAV given non-concomitantly with MMRV and PCV-7. Administration of HAV with PCV-7 and MMRV had an acceptable safety profile in 12- to 23-mo-old children.