Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults
Phase 2
Completed
- Conditions
- Influenza
- Registration Number
- NCT00382187
- Lead Sponsor
- Novartis Vaccines
- Brief Summary
The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, and of a non-adjuvanted influenza vaccine containing 15 micrograms of H5N1 influenza antigen, in adults
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Male and female volunteers 18-60 years of age
Exclusion Criteria
- Any auto-immune disease or other serious acute, chronic or progressive disease
- Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine
- History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
- Within the past 7 days, they have experienced any acute disease or infections requiring systemic antibiotic or antiviral therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT's and Seroconversion rate at day 0 and day 22 and day 43 following vaccination. day 1 to day 43
- Secondary Outcome Measures
Name Time Method Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study. Day 1 to Day 382
Trial Locations
- Locations (1)
Presidio Distrettuale N. 8, Azienda USL 7 di Siena, Via Savina Petrilli, 3
🇮🇹Siena, Italy
Presidio Distrettuale N. 8, Azienda USL 7 di Siena, Via Savina Petrilli, 3🇮🇹Siena, Italy