Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults
Phase 1
Completed
- Conditions
- Pandemic InfluenzaInfluenza A Virus InfectionOrthomyxoviridae Infections
- Registration Number
- NCT00457509
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of tolerance and immunogenicity
Primary Objective:
To describe the safety profile and immunogenicity following each injection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 251
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To provide information concerning the safety of A/H5N1 Inactivated split influenza virus vaccine Entire study period
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which adjuvants enhance H5N1 vaccine immunogenicity in immunologically naïve adults?
How does the adjuvanted H5N1 split-virion vaccine compare to standard influenza vaccines in terms of immune response and safety profiles?
Which biomarkers correlate with improved immunogenicity outcomes in NCT00457509 H5N1 vaccine trial participants?
What are the known adverse events associated with Sanofi Pasteur's adjuvanted H5N1 vaccine formulations in phase 1 clinical trials?
How do adjuvanted H5N1 vaccines from Sanofi Pasteur compare to other pandemic influenza vaccine candidates in terms of efficacy and safety?