Merck & Co., Inc. West Point, PA 19486, USA.
Pediatr Infect Dis J. 2010 Mar;29(3):263-5. doi: 10.1097/INF.0b013e3181be6257.
The pentavalent human-bovine reassortant rotavirus vaccine is indicated as a 3-dose series with first dose administered orally at 6 to 12 weeks with subsequent doses at 4 to 10 week intervals. In pre-licensure phase III trials, the majority followed this schedule, but there were 2956 instances where infants received a dose of pentavalent human-bovine reassortant rotavirus vaccine/placebo >10 weeks after the previous dose. Among this subset, the efficacy against any severity of disease, the reduction in utilization of healthcare resources and the safety profile after vaccination were comparable with overall results.
五价人-牛重组轮状病毒疫苗需要进行 3 剂接种程序，首剂口服接种的时间为 6 至 12 周龄，随后各剂间隔 4 至 10 周。在上市前 III 期临床试验中，大多数婴儿都遵循了这一接种程序，但仍有 2956 例婴儿在接种前一剂疫苗后>10 周才接种五价人-牛重组轮状病毒疫苗/安慰剂。在该亚组中，疫苗对任何严重程度疾病的疗效、对医疗资源利用的减少以及接种后的安全性与总体结果相当。
