Swine Flu (Influenza A H1N1) follow on Vaccine Study Version 1

• Research type

  Research Study

• Full title

  A multi-centre, open-label, clinical, phase 4 trial, following on from a head-to-head comparison study of two H1N1 influenza vaccines in children, to compare firstly, the persistence of antibody against the A/California/7/2009 (H1N1) virus and secondly the immunogenicity and reactogenicity of one dose of a non-adjuvanted trivalent seasonal influenza vaccine, in children who had received a two-dose immunisation regimen of Celvapan or Pandemrix.

• IRAS ID

  63469

• Contact name

  Andrew Pollard

• Sponsor organisation

  University of Oxford

• Eudract number

  2010-022817-24

• ISRCTN Number

  n/a

• Research summary

  In 2009 the UK Government purchased two pandemic influenza vaccines, Celvapan, a non-adjuvanted whole virion vaccine (Baxter: Vienna, Austria) and an adjuvanted (AS03B) split-virion vaccine (Pandemrix,GlaxoSmithKline Biologicals, Rixensart, Belgium). The UK national vaccination program used Pandemrix?½ as the first-line vaccine but switched from including only high-risk children to all children <5 years of age in November 2009, when a single dose schedule was also adopted. In Autumn 2009 we assessed the safety and immunogenicity of a two-dose schedule of both these Influenza A (H1N1) vaccines in 937 children aged 6 months to 12 years of age. It was concluded that Pandemrix, while reactogenic, was more immunogenic especially in younger children (seroconversion in children >3 years of age; 98.2% vs. 80.1%, p=0.001). It is uncertain which influenza viruses will be prevalent in the Northern Hemisphere in the approaching influenza season. However there is concern over the likely reemergence of the A/California/7/2009 (H1N1) pandemic influenza strain as the predominant cause of influenza infection as occurred in previous pandemics. The duration of the immune response to the pandemic influenza vaccines are unknown, as is the impact 2009/10 H1N1 vaccination regimens will have on the immunogenicity and reactogenicity of the trivalent seasonal influenza vaccine. This is particularly relevant given the recent Australian experience, where higher than expected reactogenicity was observed following seasonal influenza vaccination.Our unique cohort of children allows the comparison of children who received the two-dose regimen of either Celvapan or Pandemrix.This follow-on study will compare the A/California/7/2009 (H1N1) antibody persistence after these novel H1N1 influenza vaccines and immunogenicity & reactogenicity of one dose of a trivalent seasonal influenza vaccine, in cohorts receiving either Celvapen or Pandemrix to inform future H1N1 vaccination policy.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  10/H0604/81

• Date of REC Opinion

  18 Oct 2010

• REC opinion

  Favourable Opinion