University of Texas, Houston; Houston, TX USA.
Hum Vaccin Immunother. 2013 Aug;9(8):1691-7. doi: 10.4161/hv.24873. Epub 2013 Jun 6.
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.
这项开放性、多中心、随机、对照研究评估了在健康的 12-23 个月龄儿童中，VAQTA™（25U/0.5mL）（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）同时给药（第 1 组；n=330）与非同时给药（第 2 组；n=323）的免疫原性、安全性和耐受性。第 1 组在第 1 天同时接受 HAV/MMRV/PCV-7 接种，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。检查甲型肝炎血清阳性率（SPR：≥10mIU/mL；第 2 剂后 4 周）、水痘带状疱疹病毒（VZV）SPR（≥5 gpELISA 单位/mL）和肺炎链球菌的几何平均滴度（GMT）。收集注射部位和全身不良事件（AE）和每日体温。第 1 组和第 2 组接受两剂 HAV 后的甲型肝炎血清阳性率分别为 100%和 99.4%；风险差异=0.7（95%CI：-1.4，3.8，非劣效性），与初始血清阳性状态无关。第 1 组和第 2 组的 VZV SPR 分别为 93.3%和 98.3%；风险差异=-5.1（95%CI：-9.3，-1.4；非劣效性）。肺炎球菌 GMT 倍差（7 个血清型）在 0.9 到 1.1 之间；非劣效性。当 HAV 同时给药与非同时给药时，未见个体 AE 发生率有统计学意义的差异。11 例严重 AE 中有 3 例（均为第 2 组在接受 MMRV/PCV-7 后）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 天热性惊厥。无死亡报告。同时给予每种疫苗的抗体反应均不劣于 HAV 与 MMRV 和 PCV-7 同时给予。在 12-23 个月龄儿童中，HAV 与 PCV-7 和 MMRV 联合使用具有可接受的安全性。
