|
A randomised, partially observer blind, multicentre, head-to-head comparison of a two-dose regimen of Baxter and GlaxoSmithKline H1N1 pandemic vaccines, administered 21 days apart |
Nicholson KG, Abrams KR, Batham S, Clark TW, Hoschler K, Lim WS, Medina M, Nguyen-Van-Tam JS, Read RC, Warren FC, Zambon M |
|
|
Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Nicholson KG, Abrams KR, Batham S, Clark TW, Hoschler K, Lim WS, Medina M, Nguyen-Van-Tam JS, Read RC, Warren FC, Zambon M. A randomised, partially observer blind, multicentre, head-to-head comparison of a two-dose regimen of Baxter and GlaxoSmithKline H1N1 pandemic vaccines, administered 21 days apart. Health Technology Assessment 2010; 14(55): 193-334 Authors' objectives To evaluate the immunogenicity of a two-dose schedule of Baxter cell-cultured, non-adjuvanted, WV H1N1 vaccine, and GlaxoSmithKline AS03A-adjuvanted, split-virion H1N1 vaccine, with respect to the EU Committee for Human Medicinal Products for Human Use (CHMP) and the US Food and Drug Administration (FDA) licensing criteria. Authors' conclusions The AS03A-adjuvanted split-virion 2009 H1N1 vaccine is more immunogenic and provides greater antigen-sparing capacity than the WV 2009 H1N1 vaccine. The adjuvanted vaccine satisfies more CHMP criteria than the WV vaccine. Seroprotection is attained more rapidly with adjuvanted split-virion vaccine than WV vaccine. A second dose of adjuvanted split-virion vaccine increases seroprotection rates more than WV vaccine. The WV vaccine is associated with fewer local and systemic reactions than the adjuvanted vaccine, but, as judged by our findings, the adjuvanted split-virion vaccine is better overall. A single-dose strategy provides potentially greater public health benefits than delivery of two doses to one-half of the population, but a two-dose strategy should be considered for the elderly. INAHTA brief and checklist Indexing Status Subject indexing assigned by NLM MeSH Adjuvants, Immunologic /administration & Adolescent; Adult; Aged; Aged, 80 and over; Analysis of Variance; Antibodies, Viral /immunology; Chi-Square Distribution; Confidence Intervals; Cross-Sectional Studies; Female; Great Britain /epidemiology; Hemagglutination Inhibition Testss; Influenza A Virus, H1N1 Subtype /immunology /isolation & Influenza, Human /epidemiology /mortality /prevention & Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Pandemics /prevention & Prevalence; Seroepidemiologic Studies; Viral Vaccines /immunology; Young Adult; control; control /statistics & dosage /therapeutic use; numerical data; purification Language Published English Country of organisation England Address for correspondence NETSCC, Health Technology Assessment, Alpha House, University of Southampton Science Park, Southampton, SO16 7NS UK Tel: +44 23 8059 5586 Email: hta@hta.ac.uk AccessionNumber 32011000121 Date abstract record published 02/02/2011 |
|
|
|