Rhorer Janelle, Ambrose Christopher S, Dickinson Stephanie, Hamilton Holli, Oleka Napoleon A, Malinoski Frank J, Wittes Janet
Statistics Collaborative, Inc., Washington, DC 20036, USA.
Vaccine. 2009 Feb 11;27(7):1101-10. doi: 10.1016/j.vaccine.2008.11.093. Epub 2008 Dec 16.
Nine randomized clinical trials, including approximately 25,000 children aged 6-71 months and 2000 children aged 6-17 years, have evaluated the efficacy of live attenuated influenza vaccine (LAIV) against culture-confirmed influenza as compared to placebo or trivalent inactivated vaccine (TIV). We conducted meta-analyses, based on Mantel-Haenszel relative risks from fixed effect models, to provide an estimate of vaccine efficacy (VE). Relative to placebo, year 1 VE for two doses in vaccine-naïve young children was 77% (95% CI: 72%, 80%; P<0.001) against antigenically similar strains and 72% against strains regardless of antigenic similarity. Efficacy was 85%, 76%, and 73% against antigenically similar A/H1N1, A/H3N2, and B, respectively. Year 1 VE of one dose against antigenically similar strains in vaccine-naive children was 60%; efficacy of one dose in previously vaccinated children in year 2 of the various studies was 87%. In head-to-head trials comparing two doses of TIV and LAIV, vaccine-naïve children who received two doses of LAIV experienced 46% fewer cases of influenza illness caused by antigenically similar strains. Similarly, for studies including older children who had been previously vaccinated, those receiving one LAIV dose experienced 35% fewer cases of influenza illness than those receiving one TIV dose. LAIV showed high VE versus placebo with no evidence of difference by age or by circulating subtype. In these studies, LAIV was more effective than TIV.
九项随机临床试验,纳入了约25000名6至71个月大的儿童和2000名6至17岁的儿童,评估了减毒活流感疫苗(LAIV)与安慰剂或三价灭活疫苗(TIV)相比,对培养确诊流感的疗效。我们基于固定效应模型的Mantel-Haenszel相对风险进行了荟萃分析,以估计疫苗效力(VE)。相对于安慰剂,初免幼儿接种两剂疫苗后第1年针对抗原相似毒株的疫苗效力为77%(95%CI:72%,80%;P<0.001),针对所有毒株的效力为72%,无论抗原是否相似。针对抗原相似的甲型H1N1、甲型H3N2和乙型流感病毒,效力分别为85%、76%和73%。初免儿童接种一剂疫苗后第1年针对抗原相似毒株的效力为60%;在各项研究的第2年,既往接种过疫苗的儿童接种一剂疫苗的效力为87%。在比较两剂TIV和LAIV的头对头试验中,接种两剂LAIV的初免儿童因抗原相似毒株引起的流感病例减少了46%。同样,在纳入既往接种过疫苗的大龄儿童的研究中,接种一剂LAIV的儿童比接种一剂TIV的儿童流感病例减少了35%。与安慰剂相比,LAIV显示出高疫苗效力,且没有证据表明在年龄或流行亚型方面存在差异。在这些研究中,LAIV比TIV更有效