CSL Northern Hemisphere Enzira vaccine flu study

• Research type

  Research Study

• Full title

  A Phase IV, Single-Centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2009/2010 Forumulation of the Enzira® vaccine in Two Groups of Healthy Volunteers: 'Adults' (aged >18 to <60 years) and 'Older Adults' (aged >60 years). (** STAFF - CHECK TITLE IS CORRECT WHEN ISSUING LETTERS**)

• IRAS ID

  19941

• Contact name

  Ronnie Beboso

• Eudract number

  2009-011450-18

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The main purpose of the study is to evaluate the safety and protective response (immunogenicity) of Enzira© vaccine, a licensed flunza vaccine when given as a single 0.5 ml dose by injection into the upper arm in healthy 'Adults' aged greater than 18 to less than 60 years (n=60), and in healthy 'Older Adults' aged 60 and over (n=60). In addition, the study will look at the frequency of known local and general symptoms for 3 days after the vaccination in participants who receive a dose of Enzira© vaccine. Immunogenicity and safety of fluenza vaccines are assessed according to the requirements of the Committee for Proprietary Medicinal Products (CPMP). In Europe, it is a condition of registration that such studies are conducted whenever there is a strain change, and that vaccines meet the criteria set out in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for fluenza Vaccines. The maximum duration of study participation for an individual participant will be 21 ñ 4days from the day of administration of Enzira© vaccine (Day 0). A participant will have completed the Study once all study-related procedures have been conducted, and the Exit Visit (Day 21ñ 4) has been performed.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  09/H0505/62

• Date of REC Opinion

  24 Apr 2009

• REC opinion

  Favourable Opinion