Safety and Immunogenicity of H5N1 Influenza Vaccine

• Research type

  Research Study

• Full title

  Safety and Immunogenicity of an Intramuscular H5N1 Inactivated, Split Virion Influenza Vaccine Adjuvanted with AF03 in Adults and Elderly Subjects

• IRAS ID

  54825

• Contact name

  Stuart Mair

• Sponsor organisation

  sanofi pasteur S.A.

• Eudract number

  2010-019835-37

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study is investigating the H5N1 pandemic flunza vaccine, designed to protect against infection with the H5N1 flunza virus (birfluvirus). The H5N1 flunza vaccine's produced by the same methods used for production of seasonal flunza vaccine and is associated with an adjuvant. An adjuvant is a component of many vaccines, which is added to enhance the immune response.This type of vaccine has been extensively tested in previous studies conducted in Europe and the United States of America, and the adjuvanted vaccine was safe and well tolerated.The safety and protective potential of the vaccine will be compared to that of an H5N1 control vaccine that does not contain the adjuvant and that's produced by the same methods used for the adjuvanted vaccine.The adjuvanted and the control vaccines both contain a small amount of mercury salts found in the thiomersal, a preservative used in the vaccines.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/H1008/54

• Date of REC Opinion

  20 Jul 2010

• REC opinion

  Further Information Favourable Opinion