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A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Ph.Eur, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects
Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).
Details
| Lead sponsor | Novartis Vaccines |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 129 |
| Start date | 2007-07 |
| Completion | 2007-08 |
Conditions
- Influenza
Interventions
- Surface antigen inactivated influenza vaccine
Primary outcomes
- evaluate the antibody response to each influenza vaccine antigen — 21 days post-immunization
Countries
United Kingdom