Immunogenicity and Safety of Two Adjuvant Formulations of an Egg-Derived Pandemic Vaccine
Phase 1
Terminated
- Conditions
- Healthy Subjects
- Registration Number
- NCT00562237
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
Several combinations of H5N1 antigen concentrations and aluminium-hydroxide adjuvant concentrations will be tested for their safety and capacity to induce a specific immune response.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
- being healthy and ≥ 18 and ≤ 49 years of age
- willing and able to give informed consent
Exclusion Criteria
- having participated in an influenza H5 vaccine trial in the past
- known to be allergic to any constituent of the vaccine
- serious adverse reactions to previous (influenza) vaccination
- currently participating in another clinical trial or having participated in any clinical trial in the month preceding the start of the study
- using medication that influences the immune system
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Hemagglutination inhibition titers one year
- Secondary Outcome Measures
Name Time Method Virus neutralization one year CHMP criteria one year Anti-HA antibody level kinetics one year Safety one year
Trial Locations
- Locations (6)
Site 21
🇫🇮Helsinki, Finland
Site 22
🇫🇮Tampere, Finland
Site 23
🇫🇮Turku, Finland
Site 12
🇩🇪Goch, Germany
Site 10
🇩🇪Hamburg, Germany
Site 11
🇩🇪Nürnberg, Germany
Site 21🇫🇮Helsinki, Finland