Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008
Phase 2
Completed
- Conditions
- Influenza
- Interventions
- Biological: Surface antigen inactivated influenza vaccine
- Registration Number
- NCT00518453
- Lead Sponsor
- Novartis Vaccines
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
Inclusion Criteria
- Healthy Subjects eligible for enrollment into this study are male and female adult volunteers
Exclusion Criteria
- Any serious disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1: Fluvirin Surface antigen inactivated influenza vaccine -
- Primary Outcome Measures
Name Time Method evaluate the antibody response to each influenza vaccine antigen 21 days post-immunization
- Secondary Outcome Measures
Name Time Method Safety and tolerability of the study vaccine in the study population Throughout the study
Trial Locations
- Locations (1)
The Health Centre
🇬🇧Suffolk, United Kingdom