Large trials confirm immunogenicity of H1N1 vaccines

The Lancet
Jan 02, 2010  Volume 375  Number 9708  Pages 1 – 92
http://www.thelancet.com/journals/lancet/issue/current

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Large trials confirm immunogenicity of H1N1 vaccines
Heath Kelly, Ian Barr

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Since the recognition of a novel influenza A H1N1 virus, in March, 2009, the virus has spread throughout the world to cause the first influenza pandemic of this century, resulting in a cumulative incidence of death of 5–14 per million in populous southern hemisphere countries.1 In view of the high likelihood that pandemic H1N1 will circulate as a dominant strain for several years, a vaccine will be the most effective long-term mitigation measure. The Lancet today includes three studies of candidate vaccines against pandemic H1N1 that report on several separate randomised trials in China, Hungary, and the USA.

Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials
Eric Plennevaux, Eric Sheldon, Mark Blatter, Mary-Kate Reeves-Hoché, Martine Denis

Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009–10 influenza season: a multicentre, randomised controlled trial
Zoltan Vajo, Ferenc Tamas, Laszlo Sinka, Istvan Jankovics

Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial
Xiao-Feng Liang, Hua-Qing Wang, Jun-Zhi Wang, Han-Hua Fang, Jiang Wu, Feng-Cai Zhu, Rong-Cheng Li, Sheng-Li Xia, Yu-Liang Zhao, Fang-Jun Li, Shao-Hong Yan, Wei-Dong Yin, Kang An, Duo-Jia Feng, Xuan-Lin Cui, Feng-Chun Qi, Chang-Jun Ju, Yu-Hui Zhang, Zhi-Jun Guo, Ping-Yu Chen, Ze Chen, Kun-Ming Yan, Yu Wang

Defining the safety profile of pandemic influenza vaccines
Dina Pfeifer, Claudia Alfonso, David Wood
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Vaccines have side-effects. When making decisions about regulatory approval and public health use of vaccines, authorities need to be convinced that the benefits of reduced disease outweigh actual and potential risks of vaccination. The side-effect profiles of influenza vaccines are well known due to more than 50 years of large-scale use. However, influenza vaccines uniquely undergo changes in their strain composition virtually every year. Critical evaluation of the safety profile of the vaccines manufactured to respond to the 2009 H1N1 pandemic is of the highest priority.

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