Head to head study of influenza H1N1 vaccines in adults

• Research type

  Research Study

• Full title

  A randomised, partially observer-blind, multi-centre, head-to-head comparison of a two dose regimen of Baxter and GSK H1N1 pandemic vaccines, administered 21 days apart.'

• IRAS ID

  31843

• Sponsor organisation

  University Hospitals of Leicester NHS Trust

• Eudract number

  2009-015743-16

• ISRCTN Number

  92328241

• Research summary

  This study tests two vaccines that have been purchased from two manufacturers by the Government to protect the population from the pandemic of H1N1 flunza. The two vaccines differ in the way in which they have been made. They also differ in their strength (the content of coat protein from the virus). We plan to give two doses of each vaccine 21 days apart to a total of 360 adults aged 18 years and older. 180 people will receive vaccine from one manufacturer, and 180 people will receive vaccine from the other manufacturer. If both vaccines are available at the same time, we will randomly allocate the vaccine'so that subjects, investigators (except the person giving vaccine), and laboratory investigators are all unaware which vaccine was given to any subject. We will collect blood samples before vaccination on Day 0, and then 7, 14, 21, 28, 35, 42, and 180 days later. We will test the blood samples for antibodies to the pandemic virus to measure the likely protection. The timing of the blood sampling will allow us to see whether one vaccine dose is enough, or whether two are necessary. We will also be able to see how quickly people will become immune and whether immunity lasts for 6 months. We will assess each vaccine against criteria provided by the European Union and will also compare them with one another. We will ask subjects to keep diary cards so that we can see whether the vaccines are well tolerated. The trial was successful, differences between the two vaccines were found, and the results were published both as an HTA report and as a publication in a peer-reviewed journal.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  09/H0720/111

• Date of REC Opinion

  21 Sep 2009

• REC opinion

  Favourable Opinion