CSL Enzira Vaccine in two groups of healthy volunteers.

• Research type

  Research Study

• Full title

  A Phase IV, single-centre, open-label study to evaluate the immunogenicity and safety of the 2010/2011 formulation of the Enzira® Vaccine in two groups of healthy volunteers: 'Adults' (aged 18 to 59 years) and 'Older Adults' (aged 60 years and older).

• IRAS ID

  48273

• Contact name

  Ronnie Beboso

• Sponsor organisation

  CSL Limited

• Eudract number

  2010-019532-12

• Research summary

  The evaluation of how much of an immune or protective response (the immunogenicity) experienced of the Enzira© vaccine in healthy 'Adults' = 18 to < 60 years, and in healthy 'Older Adults' aged = 60 years, according to the criteria of the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for flunza Vaccines.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  10/S0501/25

• Date of REC Opinion

  21 Apr 2010

• REC opinion

  Favourable Opinion