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Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection (Trivalent, Seasonal Influenza Vaccine, Active Ingredient Content: 15 ugHA/Strain/0.5mL) in Adult and Elderly Subjects
This is a yearly licence tolerability and immunogenicity study of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/strain/0.5mL) in adult and elderly subjects to assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection, as measured by haemagglutination inhibition (HI) test, and to evaluate safety and tolerability (incidence of adverse events) of a single intramuscular injection of Fluval AB suspension for injection.
Details
| Lead sponsor | Fluart Innovative Vaccine Ltd, Hungary |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 120 |
| Start date | 2012-08 |
| Completion | 2012-09 |
Conditions
- Influenza
Interventions
- Fluval AB vaccination
Primary outcomes
- Assessment of immunogenicity measures in comparison to criteria specified in CPMP/BWP/214/96 — 21-28 days after immunization
To assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/0.5mL of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test in comparison to criteria specified in CPMP/BWP/214/96.
Countries
Hungary