• Yan-Ping Li, Wei Li, Xiao-Feng Liang, Yan Liu, Xiao-Chun Huang, Chang-Gui Li, Rong-Cheng Li, Jun-Zhi Wang, Hua-Qing Wang, and Wei-Dong Yin.
• Guangxi Centers for Diseases Control and Prevention, Nanning.National Institutes for Food and Drug Control, Beijing.Chinese Center for Disease Control and Prevention, Beijing.Sinovac Biotech Co. Ltd, Beijing.Lingchuan Center for Disease Control and Prevention, Guilin, China.
• Influenza Other Respi Viruses. 2013 Nov 1;7(6):1297-307.

ObjectivesThe goal of this double-blind, randomized, controlled clinical trial was to assess the safety and immunogenicity of two different doses of a monovalent split-virion 2009 pandemic influenza A/H1N1 vaccine without adjuvant in Chinese infants aged 6-35 months. DESIGN AND SETTING  Subjects were randomly assigned to receive either a 2009 pandemic (H1N1) vaccine containing 7.5 or 15 μg haemagglutinin (HA) or a seasonal influenza vaccine. 2 doses of the H1N1 vaccines or the seasonal influenza vaccine were given 21 days apart in younger infants aged 6-23 months or older infants aged 24-35 months.SampleSerum samples were collected immediately before the first injection and before and 21 days after the second injection.Main Outcome MeasuresPrimary outcomes were haemagglutinin inhibition (HI) antibody responses 21 days following each vaccination. Safety was monitoring throughout the study.ResultsThe first vaccination of 7.5 μg and 15 μg H1N1 vaccine induced seroprotective antibody titers (HI titers≥1: 40) in 42.9-57.4% of younger infants and 49.1-61.0% older infants. Immune responses after completion of the two dose schedule were comparable in both age groups with seroprotective rates of 91-98% in each vaccine and age group and GMTs of 173-263. The H1N1 vaccine elicited similar rates of local and systemic adverse reactions as the seasonal influenza vaccine.ConclusionsThe 2009 pandemic influenza A /H1N1 vaccine were highly immunogenic in infants aged 6-35 months, and displayed a safety and reactogenicity profile similar to the seasonal influenza vaccine.Trial RegistrationClinicalTrial.gov identifier: NCT01047202.© 2012 John Wiley & Sons Ltd.

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