Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, St. Louis, MO 63104, USA.
J Infect Dis. 2012 Sep 15;206(6):828-37. doi: 10.1093/infdis/jis445. Epub 2012 Jul 16.
Administering 2 separate vaccines for seasonal and pandemic influenza was necessary in 2009. Therefore, we conducted a randomized trial of monovalent 2009 H1N1 influenza vaccine (2009 H1N1 vaccine) and seasonal trivalent inactivated influenza vaccine (TIV; split virion) given sequentially or concurrently in previously vaccinated children.
Children randomized to 4 study groups and stratified by age received 1 dose of seasonal TIV and 2 doses of 2009 H1N1 vaccine in 1 of 4 combinations. Injections were given at 21-day intervals and serum samples for hemagglutination inhibition antibody responses were obtained prior to and 21 days after each vaccination. Reactogenicity and adverse events were monitored.
All combinations of vaccines were safe in the 531 children enrolled. Generally, 1 dose of 2009 H1N1 vaccine and 1 dose of TIV, regardless of sequence or concurrency of administration, was immunogenic in children ≥ 10 years of age; children <10 years of age required 2 doses of 2009 H1N1 vaccine.
Vaccines were generally well tolerated. The immune responses to 2009 H1N1 vaccine were adequate regardless of the sequence of vaccination in all age groups but the sequence affected titers to TIV antigens. Two doses of 2009 H1N1 vaccine were required to achieve a protective immune response in children <10 years of age.
NCT00943202.
2009 年，需要同时接种两种疫苗来预防季节性流感和大流行性流感。因此，我们进行了一项随机试验，比较了单价 2009 年 H1N1 流感疫苗（2009 年 H1N1 疫苗）和季节性三价灭活流感疫苗（裂解病毒）先后序贯或同时接种在已接种疫苗儿童中的效果。
随机分为 4 组的儿童按年龄分层，接受 1 剂季节性 TIV 和 2 剂 2009 年 H1N1 疫苗，4 种组合中的 1 种。间隔 21 天给予注射，在每次接种前和接种后 21 天采集血清样本进行血凝抑制抗体反应。监测不良反应和不良事件。
531 名入组儿童的所有疫苗组合均安全。一般来说，1 剂 2009 年 H1N1 疫苗和 1 剂 TIV，无论给药顺序如何，均可在年龄≥10 岁的儿童中产生免疫原性；年龄<10 岁的儿童需要接种 2 剂 2009 年 H1N1 疫苗。
疫苗通常具有良好的耐受性。在所有年龄组中，无论接种顺序如何，2009 年 H1N1 疫苗的免疫应答均足够，但接种顺序会影响 TIV 抗原的滴度。10 岁以下儿童需要接种 2 剂 2009 年 H1N1 疫苗才能产生保护性免疫应答。
NCT00943202。
