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首页> 外文期刊>Vaccine >Safety and immunogenicity of 2010-2011 H1N12009-containing trivalent inactivated influenza vaccine in children 12-59 months of age previously given AS03-adjuvanted H1N12009 pandemic vaccine: A PHAC/CIHR Influenza Research Network (PCIRN) study
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Safety and immunogenicity of 2010-2011 H1N12009-containing trivalent inactivated influenza vaccine in children 12-59 months of age previously given AS03-adjuvanted H1N12009 pandemic vaccine: A PHAC/CIHR Influenza Research Network (PCIRN) study

机译：PHAC / CIHR流感研究网络（PCIRN）研究的2010-2011年含H1N12009的三价灭活流感疫苗在12至59个月大的儿童中曾接受过AS03辅助H1N12009大流行疫苗的安全性和免疫原性

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Background: Concern arose in 2010 that reactogenicity, particularly febrile seizures, to influenza A/H1N1-containing 2010-2011 trivalent seasonal inactivated influenza vaccine (TIV) could occur in young children who had been previously immunized and/or infected with the pandemic strain. We conducted a pre-season study of 2010-2011 TIV safety and immunogenicity in children 12-59 months of age to inform public health decision making. Methods: Children immunized with 1 or 2 doses of the pandemic vaccine, with or without the 2009-10 TIV, received 1 or 2 doses of 2010-11 TIV in an observational, multicentre Canadian study. Standard safety monitoring was enhanced by a telephone call at similar to 24 h post-TIV when adverse events were expected to peak. Summary safety reports were rapidly reported to public health before the launch of public programs. TIV immunogenicity was assessed day 0, and 21 days after final vaccination. Clinical Trials Registration NCT01180621. Results: Among 207 children, a general adverse event was reported by 60.9% of children post-dose one and by 58.3% post-dose two. Only severe fever (>38.5 degrees C) was more common in two-dose compared to one dose recipients (16.7%, n = 4 v. 1.0%, n = 2). At baseline 99.0% of participants had A/H1N1 hemagglutinin inhibition (HAI) titers >= 10, and 85.5% had a protective titer of >= 40 (95% CI 80.0, 90.0). Baseline geometric mean titers (GMT) were higher in recipients of a 2-dose schedule of pandemic vaccine compared to one-dose recipients: 153.1 (95% CI 126.2, 185.7) v. 78.8 ((58.1, 106.8, p < 0.001). At 21 days, all regulatory criteria for influenza vaccine immunogenicity were exceeded for A/H1N1 and H3N2, but responses to the B antigen were poor. No correlations between reactogenicity and either baseline high influenza titers or serologic response to revaccination were evident. Conclusions: Infants and toddlers who received AS03-adjuvanted A/H1N1 2009 vaccine up to 11 months earlier retained high titers in the subsequent season but re-exposure to A/H1N1 2009 antigen in TIV resulted in no unusual adverse effects and 100% were sero-protected for A/H1N1 after receipt of the 2010-11 TIV. (C) 2012 Elsevier Ltd
机译：背景：2010年引起了人们的关注，即先前曾接受过大流行毒株免疫和/或感染的幼儿可能会对含有A / H1N1流感的2010-2011三价季节性灭活流感疫苗（TIV）产生反应原性，特别是高热惊厥。我们对12-59个月大的孩子进行了2010-2011年TIV安全性和免疫原性的季前研究，以为公共卫生决策提供依据。方法：在加拿大一项观察性，多中心研究中，使用1或2剂大流行疫苗（有或没有2009-10 TIV）进行免疫的儿童接受了1或2剂2010-11 TIV。当预计不良事件达到高峰时，类似于TIV后24小时的电话，可以加强标准安全监控。在启动公共计划之前，已向公共卫生迅速报告了简要的安全报告。在最终疫苗接种后第0天和21天评估TIV免疫原性。临床试验注册NCT01180621。结果：在207名儿童中，据报道，一次给药后儿童发生一般不良事件的发生率为60.9％，两次给药后儿童发生的不良事件为58.3％。与一次剂量接受者相比，两次剂量相比仅严重发烧（> 38.5摄氏度）更为常见（16.7％，n = 4对1.0％，n = 2）。在基线时，99.0％的参与者的A / H1N1血凝素抑制（HAI）滴度> = 10，而85.5％的保护性滴度> = 40（95％CI 80.0，90.0）。 2剂大流行疫苗接种者的基线几何平均滴度（GMT）高于单剂接受者：153.1（95％CI 126.2，185.7）vs. 78.8（（58.1，106.8，p <0.001）。在第21天，A / H1N1和H3N2均超过了所有流感疫苗免疫原性的监管标准，但对B抗原的反应较差，反应原性与基线高流感滴度或对疫苗接种的血清学反应之间没有相关性。在11个月之前接受AS03辅助A / H1N1 2009疫苗的婴幼儿在随后的季节中仍保持较高的滴度，但在TIV中再次暴露于A / H1N1 2009抗原则没有异常的不良反应，并且100％接受了血清保护收到2010-11 TIV之后的A / H1N1（C）2012 Elsevier Ltd

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