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A rapid immune response to 2009 influenza A(H1N1) vaccines in adults: a randomized, double-blind, controlled trial.

Author(s): 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

Affiliation(s): Beijing Centers for Disease Control and Prevention, Beijing, China.

Publication date & source: 2010-09-01, J Infect Dis., 202(5):675-80.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

A double-blind, randomized, controlled trial involving 706 adults was conducted to evaluate the immunogenicity and safety of different dosages of whole-virion or split-virion H1N1 influenza vaccines with or without aluminum adjuvant. A rapid and strong immune response was induced at day 14 after the first injection. The seroprotection rates ranged from 72.7% (95% confidence interval [CI], 62.7%-81.1%) for 5-microg whole-virion aluminum formulation to 97.0% (95% CI, 90.9%-99.7%) for 30-microg split-virion nonaluminum formulation. All formulations were well tolerated. The incidences of mild, moderate, and severe reactions were 71 (10.1%), 15 (2.1%), and 1 (0.1%) of 706 reactions, respectively. The 15-microg split-virion formulation had the best immunogenicity and safety.

Page last updated: 2010-10-05

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