A Clinical Trial With Influenza A/H1N1 Vaccines

Summary

A single center, stratified, randomized and double-blind phase IV clinical trial is to be conducted in healthy elders (equal to or more than 61 years), adults (18-60 years), adolescents (12-17 years) and children (3-11 years) to evaluate the safety and immunogenicity of Sinovac's split-virion or whole-virion novel influenza A (H1N1) vaccines.

Timeline

Start

2009-07

Primary completion

2009-09

Completion

2009-10

Publications

• Wu J, Li W, Wang HQ, Chen JT, Lv M, Zhou JC, Liang XF, Fang HH, Liu Y, Liu LY, Wang X, Zhang WL, Zhang XM, Song LF, Qiu YZ, Li CG, Wang JZ, Wang Y, Yin WD. A rapid immune response to 2009 influenza A(H1N1) vaccines in adults: a randomized, double-blind, controlled trial. J Infect Dis. 2010 Sep 1;202(5):675-80. doi: 10.1086/655226.
• Liang XF, Wang HQ, Wang JZ, Fang HH, Wu J, Zhu FC, Li RC, Xia SL, Zhao YL, Li FJ, Yan SH, Yin WD, An K, Feng DJ, Cui XL, Qi FC, Ju CJ, Zhang YH, Guo ZJ, Chen PY, Chen Z, Yan KM, Wang Y. Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2010 Jan 2;375(9708):56-66. doi: 10.1016/S0140-6736(09)62003-1. Epub 2009 Dec 15.

Drugs

Indications