A Study to Assess the Immunogenicity and Safety of CSL's 2012/2013 Formulation of Enzira® Vaccine in Healthy Volunteers
This is a study to assess the immune (antibody) response and safety of the 2012/2013 formulation of Enzira® (CSL Influenza vaccine) in healthy adult volunteers aged 18 years or older.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official 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)|
- The percentage of evaluable participants achieving seroconversion or significant increase in antibody titre. [ Time Frame: Approximately 21 days after vaccination ] [ Designated as safety issue: No ]As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10; significant increase is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.
- The geometric mean fold increase (GMFI) in antibody titre after vaccination. [ Time Frame: Approximately 21 days after vaccination ] [ Designated as safety issue: No ]GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.
- The percentage of evaluable participants achieving a HI titre ≥ 40 or single radial haemolysis (SRH) area ≥ 25 mm2. [ Time Frame: Approximately 21 days after vaccination ] [ Designated as safety issue: No ]
- Frequency and intensity of any solicited adverse events (AEs). [ Time Frame: During the 4 days after vaccination (Day 0 plus 3 days) ] [ Designated as safety issue: Yes ]
The percentage of subjects reporting any solicited AEs and the percentage of subjects reporting any solicited AEs with severe intensity.
Solicited AE intensity grading: Mild: symptoms are easily tolerated and there is no interference with daily activities; Moderate: enough discomfort to cause some interference with daily activities; Severe: symptoms that prevent normal, everyday activities.
- Frequency of any unsolicited AEs. [ Time Frame: After vaccination until the end of the study; approximately 21 days ] [ Designated as safety issue: Yes ]The percentage of subjects reporting any unsolicited AEs
|Study Start Date:||May 2012|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Biological: CSL Influenza Vaccine
- Enzira® vaccine
- Afluria® vaccine