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A Phase IV, Single-centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2009/2010 Formulation of the Enzira® Vaccine in Two Groups of Healthy Volunteers: 'Adults' (Aged ≥ 18 to < 60 Years) and 'Older Adults' (Aged ≥ 60 Years).
The purpose of the study is to assess the efficacy and safety of CSL's 2009/2010 formulation of the Enzira vaccine.
Details
| Lead sponsor | Seqirus |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 120 |
| Start date | 2009-05 |
| Completion | 2009-05 |
Conditions
- Influenza
Interventions
- Inactivated Influenza Vaccine (2009 / 2010 formulation)
Primary outcomes
- The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. — Approximately 21 days after vaccination
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. — Approximately 21 days after vaccination
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. — Approximately 21 days after vaccination
Countries
United Kingdom