Department of Maternal and Pediatric Sciences, Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Commenda 9, 20122 Milan, Italy.
Vaccine. 2010 Aug 31;28(38):6137-44. doi: 10.1016/j.vaccine.2010.07.041. Epub 2010 Jul 29.
This study evaluated the immunogenicity of a double dose of the seasonal virosomal-adjuvanted influenza vaccine (Inflexal V, Crucell, The Netherlands) in 65 previously unvaccinated children aged less than 3 years: 43 received double doses (two doses of 0.50 mL 4 weeks apart) and 22 standard doses (two doses of 0.25 mL 4 weeks apart). Both treatments evoked a response that satisfied the EMEA criteria for adequate immunogenicity for all three vaccine strains, but the double dose had a significantly greater effect on all of the studied parameters of humoral and cell-mediated immune response (p<0.05). This result was achieved without any increase in the incidence of local and systemic adverse events. This means that doubling the dose of the virosomal-adjuvanted influenza vaccine (i.e. administering the same dose as that usually given to older children) effectively and safely increases the immune response to inactivated influenza vaccine in unprimed children aged less than 3 years.
本研究评估了双剂量季节性病毒样颗粒佐剂流感疫苗（Inflexal V，Crucell，荷兰）在 65 名以前未接种过疫苗的 3 岁以下儿童中的免疫原性：43 名儿童接受了双剂量（两次 0.50 毫升剂量，间隔 4 周），22 名儿童接受了标准剂量（两次 0.25 毫升剂量，间隔 4 周）。两种治疗方法均引发了符合 EMEA 适当免疫原性标准的反应，适用于所有三种疫苗株，但双剂量对体液和细胞介导免疫反应的所有研究参数均具有更显著的影响（p<0.05）。这一结果在不增加局部和全身不良事件发生率的情况下实现。这意味着，双倍剂量的病毒样颗粒佐剂流感疫苗（即给予与通常给予较大儿童相同的剂量）可有效且安全地增强未接种疫苗的 3 岁以下儿童对灭活流感疫苗的免疫反应。
