Langley Joanne M, Vanderkooi Otto G, Garfield Hartley A, Hebert Jacques, Chandrasekaran Vijayalakshmi, Jain Varsha K, Fries Louis
Canadian Center for Vaccinology Dalhousie University IWK Health Centre Halifax, Nova Scotia
University of Calgary.
J Pediatric Infect Dis Soc. 2012 Mar;1(1):55-63. doi: 10.1093/jpids/pis012. Epub 2012 Mar 1.
Improved influenza vaccine strategies for infants and preschool children are a high priority.
The immunological response and safety of a thimerosal-free trivalent inactivated influenza vaccine at 2 different doses (0.50 mL vs 0.25 mL) was evaluated in children aged 6-35 months. The study was randomized, observer blind, multicenter, and stratified by age (6-23 months and 24-35 months), and it accounted for prior influenza immunization status.
Three hundred seventy-four children were in the total vaccinated cohort (study vaccine 0.25-mL dose, n = 164; 0.50-mL dose, n = 167; comparator 0.25 mL, n = 43). Regulatory criteria for immunogenicity of influenza vaccines in adults were met for all virus strains and doses for both age strata. A modest but not statistically significant improvement in immune responses was observed with the higher dose and reactogenicity, and safety of the 2 doses was not significantly different.
The 0.5-mL dose of the study vaccine, when administered to children aged 6-35 months, resulted in a modest but not statistically significant improvement in immunogenicity with clinically similar safety and reactogenicity compared with the 0.25-mL dose. Further studies comparing full- and half-dose influenza vaccine in young children are needed.
NCT00778895.
改进针对婴幼儿和学龄前儿童的流感疫苗策略是当务之急。
在6至35个月大的儿童中评估了两种不同剂量（0.50毫升与0.25毫升）的无硫柳汞三价灭活流感疫苗的免疫反应和安全性。该研究为随机、观察者盲法、多中心研究，并按年龄（6至23个月和24至35个月）分层，同时考虑了既往流感免疫状况。
总共有374名儿童纳入接种队列（研究疫苗0.25毫升剂量组，n = 164；0.50毫升剂量组，n = 167；对照0.25毫升组，n = 43）。两个年龄层的所有病毒株和剂量均达到了成人流感疫苗免疫原性的监管标准。高剂量组在免疫反应上有适度但无统计学意义上的改善，且两种剂量的反应原性和安全性无显著差异。
与0.25毫升剂量相比, 给6至35个月大的儿童接种0.5毫升剂量的研究疫苗时，免疫原性有适度但无统计学意义上的改善，临床安全性和反应原性相似。需要进一步开展比较幼儿全剂量和半剂量流感疫苗的研究。
NCT00778895。
