Last reviewed · How we verify
A Phase IV, Single-Centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2013/2014 Formulation of a bioCSL Split Virion, Inactivated Influenza Vaccine in Healthy Volunteers Aged 18-60 Years
This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated influenza vaccine containing the 2013/2014 formulation of Enzira® vaccine in healthy adult volunteers aged between 18 and 60 years.
Details
| Lead sponsor | Seqirus |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 120 |
| Start date | 2013-05 |
| Completion | 2013-06 |
Conditions
- Influenza, Human
Interventions
- Trivalent Influenza Vaccine
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 (H1N1, H3N2, and B influenza virus strains) is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of \< 10. A significant increase (H1N1, H3N2, and B influenza virus strains) 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 (H1N1, H3N2, and B influenza virus strains) 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
For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected.
Countries
United Kingdom