Department of Pediatrics, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
Vaccine. 2010 Feb 10;28(6):1566-74. doi: 10.1016/j.vaccine.2009.11.054. Epub 2009 Dec 8.
Children aged 11 to <24 months received 2 intranasal doses of live attenuated influenza vaccine (LAIV) or placebo, 35+/-7 days apart. Dose 1 was administered concomitantly with a combined measles, mumps, and rubella vaccine (Priorix). Seroresponses to measles and mumps were similar between groups. Compared with placebo, response rates to rubella in LAIV+Priorix recipients were statistically lower at a 15 IU/mL threshold (83.9% vs 78.0%) and the prespecified noninferiority criteria were not met. In a post hoc analysis using an alternate widely accepted threshold of 10 IU/mL, the noninferiority criteria were met (93.4% vs 89.8%). Concomitant administration with Priorix did not affect the overall influenza protection rate of LAIV (78.4% and 63.8% against antigenically similar influenza strains and any strain, respectively).
11 至<24 月龄的儿童间隔 35+/-7 天接受 2 剂鼻内用减毒活流感疫苗(LAIV)或安慰剂。第 1 剂与麻疹、腮腺炎和风疹联合疫苗(Priorix)同时接种。麻疹和风疹的血清应答在各组之间相似。与安慰剂相比,LAIV+Priorix 组接种者风疹的抗体反应率在 15IU/mL 阈值(83.9%比 78.0%)时统计学上较低,且未达到预设的非劣效性标准。在使用另一个广泛接受的 10IU/mL 阈值的事后分析中,非劣效性标准得到满足(93.4%比 89.8%)。与 Priorix 同时给药不会影响 LAIV 的总体流感保护率(针对抗原相似的流感株和任何株,分别为 78.4%和 63.8%)。