Effects of the Enzira® flu vaccine; version 1

• Research type

  Research Study

• Full title

  A Phase IV, Single-Centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2012/2013 Formulation of the Enzira® vaccine in Two Groups of Healthy Volunteers: ‘Adults’ (aged 18 to 59 years) and ‘Older Adults’ (aged 60 years or older). (11-505)

• IRAS ID

  103226

• Contact name

  Steve Warrington

• Sponsor organisation

  CSL Limited

• Eudract number

  2012-001101-24

• ISRCTN Number

  n/a

• Research summary

  This is a study to assess the immune (antibody) response and safety of the 2012/2013 formulation of Enzira© (CSL flunza vaccine) in healthy adult volunteers, aged 18 years or older. The vaccine is a licensed flunza vaccine manufactured by CSL Biotherapies and contains 3 strains of inactivated (non-infectious) flunza virus that have been officially recommended for the Northern Hemisphere 2012/2013 flunza season. Participants must meet certain criteria to take part in the study. A blood sample will be taken before, and about 21 days after, a single injection of the vaccine. The blood samples will be used to assess the participant's immune response to the vaccine. Participants will be asked to record side effects known to be common aftefluvaccination, during the 4 days after vaccination, and other possible side effects for the duration of the study. Participants will take up to 30 days to finish the study and will make 2 or more outpatient visits. The study will take place at one centre.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  12/SC/0178

• Date of REC Opinion

  17 Apr 2012

• REC opinion

  Further Information Favourable Opinion