Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT00599443
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
A controlled, double blinded study to determine the safety and reactogenicity in healthy adults of a single dose of a trivalent cell-derived influenza vaccine administered by intramuscular injection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Healthy female or male subjects aged ≧18 and ≦49 years
- Willing and able to give informed consent
Exclusion Criteria
- Influenza vaccination of laboratory confirmed influenza infection within six months of informed consent,
- presence of any significant medical condition,
- a serious adverse reaction after a previous (influenza) vaccination,
- underlying medical conditions for which annual influenza vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP),
- chronic diseases requiring long-term immunosuppressive therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety and tolerability of one dose of cell-derived influenza vaccine in healthy adults aged ≧18 years and ≦ 49 years after vaccination. 3 weeks Long-term safety 6 months
- Secondary Outcome Measures
Name Time Method HI antibody titers 3 weeks