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Influenza H1N1 (swine flu) vaccination: a safety surveillance feasibility study using self-reporting of serious adverse events and pregnancy outcomes
Version of Record online: 5 APR 2012
© 2011 The Authors. British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society
British Journal of Clinical Pharmacology
Volume 73, Issue 5, pages 801–811, May 2012
How to Cite
Mackenzie, I. S., MacDonald, T. M., Shakir, S., Dryburgh, M., Mantay, B. J., McDonnell, P. and Layton, D. (2012), Influenza H1N1 (swine flu) vaccination: a safety surveillance feasibility study using self-reporting of serious adverse events and pregnancy outcomes. British Journal of Clinical Pharmacology, 73: 801–811. doi: 10.1111/j.1365-2125.2011.04142.x
- Issue online: 5 APR 2012
- Version of Record online: 5 APR 2012
- Accepted manuscript online: 15 NOV 2011 02:08AM EST
- Received; 22 July 2011; Accepted; 26 October 2011; Accepted Article Published Online; 15 November 2011
- 2The Scottish Government. Swine flu pandemic [online]. 2011. Available at http://www.scotland.gov.uk/Topics/Health/health/flu/swineflu (last accessed 13 April 2011). The Scottish Government 2011 March 1.
- 3MHRA. Final Public Summary. UK suspected adverse reaction analysis. Swine Flu (H1N1) Vaccines – Celvapan and Pandemrix.[online]. 2010. Available at http://www.mhra.gov.uk/home/groups/pl-p/documents/websiteresources/con078911.pdf (last accessed 10 May 2011).
- 6Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009-10 influenza season: a multicentre, randomised controlled trial. Lancet 2010; 375: 49–55., , , .
- 12ICH Harmonised Tripartite Guideline. Post-approval safety data management: definitions and standards for expedited reporting E2D. 2003.
- 13Causality and correlation in pharmacovigilance. In: Stephens' Detection of New Adverse Drug Reactions, 5th edn. eds Talbot J, Waller P. Chichester: John Wiley & Sons Ltd, 2004; 329–43..
- 15Abstract no: 733. Participation of general practices in a swine flu vaccination study. 26th International Conference on Pharmacoepidemiology & Therapuetic Risk management (ISPE). 19-22ndth August, 2010 – Brighton, UK. Pharmacoepidemiol Drug Saf 2010; 19: s328., , , , , .
- 20European Medicines Agency. Press release. European Medicines Agency reviews further data on narcolepsy and possible association with Pandemrix Doc Ref: EMEA/CHMP/130422/2011. [online]. 2011. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2011/02/WC500102213.pdf (last accessed 12 December 2011). The European Medicines Agency (EMEA) 2011 February 18.