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 ID 32011000121
English
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' recommendations:
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.
Details
Project Status:
Completed
URL for project:
http://www.hta.ac.uk/fullmono/mon1455.pdf#nameddest=article04
Year Published:
2010
URL for published report:
http://www.hta.ac.uk/project/2226.asp
English language abstract:
An English language summary is available
Publication Type:
Not Assigned
Country:
England, United Kingdom
MeSH Terms
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Analysis of Variance
- Chi-Square Distribution
- Confidence Intervals
- Cross-Sectional Studies
- Female
- Logistic Models
- Male
- Middle Aged
- Multivariate Analysis
- Odds Ratio
- Prevalence
- Seroepidemiologic Studies
- Young Adult
- Adjuvants, Immunologic
- Antibodies, Viral
- Influenza A Virus, H1N1 Subtype
- Influenza, Human
- Pandemics
- Viral Vaccines
Contact
Organisation Name:
NIHR Health Technology Assessment programme
Contact Address:
NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name:
journals.library@nihr.ac.uk
Contact Email:
journals.library@nihr.ac.uk
Copyright:
2010 Queen's Printer and Controller of HMSO
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.