Immunogenicity of Fluvirin® Influenza Vaccine Formulation 2009-2010

• Research type

  Research Study

• Full title

  A Phase II, single center, uncontrolled, open label study to evaluate safety and immunogenicity of FLUVIRIN® [Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur], Formulation 2009/2010, when Administered to Adult and Elderly Subjects

• Contact name

  Richard John West

• Sponsor organisation

  Novartis Vaccines and Diagnostics GmbH & Co. KG

• Eudract number

  2009-011004-33

• ISRCTN Number

  finished

• Research summary

  This study was designed to evaluate the immunogenicity and safety of the 2009/201fluirin fluza Vaccine intended for use in Northern Hemisphere. The study enrolled healthy subjects who were adults (18 to 60 years of age) or elderly adults (61 years of age and older). The subjects were evaluated by antibody testing before and after administration of one dose of vaccine and were also evaluated for safety by examination of adverse events after vaccination, both solicited and sponteneously reported. The antibody levels were evaluated prior to and through 21 days after vaccinationby single radial haemolysis and haemagglutination inhibition assays to determine ifluirin met the criteria for licensure renewal as outlined by EMA guidance CPMP/BWP/214/96.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  09/H0301/23

• Date of REC Opinion

  26 May 2009

• REC opinion

  Further Information Favourable Opinion