Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine
Phase 1
Completed
- Conditions
- InfluenzaOrthomyxoviridae Infections
- Interventions
- Biological: Monovalent subvirion H5N1 influenza vaccineBiological: Physiological saline
- Registration Number
- NCT00664417
- Lead Sponsor
- Sanofi
- Brief Summary
Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated. The present study is part of this endeavor. It is primarily a formulation/dose-finding study with a secondary aim at generating safety and immunogenicity data for the final formulation for the development of a pre-pandemic vaccine.
- Detailed Description
This is a Phase I, observer-blinded, randomized, controlled multicenter, dose-finding study in adult subjects. All vaccines will be administered as a two-dose schedule in (H5N1) immunologically-naïve adults. Immunogenicity and safety will be evaluated after each injection.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 375
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Monovalent subvirion H5N1 influenza vaccine - 4 Monovalent subvirion H5N1 influenza vaccine - 5 Monovalent subvirion H5N1 influenza vaccine - 1 Monovalent subvirion H5N1 influenza vaccine - 2 Monovalent subvirion H5N1 influenza vaccine - 6 Monovalent subvirion H5N1 influenza vaccine - 7 Monovalent subvirion H5N1 influenza vaccine - 8 Monovalent subvirion H5N1 influenza vaccine - 9 Physiological saline -
- Primary Outcome Measures
Name Time Method To provide information concerning the safety after primary administration of A/H1N1 vaccine 6 months post-vaccination
- Secondary Outcome Measures
Name Time Method