tetano
Editor, Senior Moderator
J Infect Dis. 2010 Jul 15. [Epub ahead of print]
A Rapid Immune Response to 2009 Influenza A(H1N1) Vaccines in Adults: A Randomized, Double-Blind, Controlled Trial.
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.
Beijing Centers for Disease Control and Prevention, 2National Institute for the Control of Pharmaceuticals and Biological Products, 3Chinese Centers for Disease Control and Prevention, 4Sinovac Biotech Co Ltd, and 5Huairou Center for Disease Control and Prevention, Beijing, China.
Abstract
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-mug whole-virion aluminum formulation to 97.0% (95% CI, 90.9%-99.7%) for 30-mug 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-mug split-virion formulation had the best immunogenicity and safety. Trial Registration. ClinicalTrials.gov identifier: NCT00956111 .
PMID: 20632888 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/20632888
A Rapid Immune Response to 2009 Influenza A(H1N1) Vaccines in Adults: A Randomized, Double-Blind, Controlled Trial.
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.
Beijing Centers for Disease Control and Prevention, 2National Institute for the Control of Pharmaceuticals and Biological Products, 3Chinese Centers for Disease Control and Prevention, 4Sinovac Biotech Co Ltd, and 5Huairou Center for Disease Control and Prevention, Beijing, China.
Abstract
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-mug whole-virion aluminum formulation to 97.0% (95% CI, 90.9%-99.7%) for 30-mug 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-mug split-virion formulation had the best immunogenicity and safety. Trial Registration. ClinicalTrials.gov identifier: NCT00956111 .
PMID: 20632888 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/20632888