EUCTR2010-019835-37-BE
Active, not recruiting
Not Applicable
Safety and Immunogenicity of an Intramuscular H5N1 Inactivated, Split Virion Influenza Vaccine Adjuvanted with AF03 in Adults and Elderly subjects
Sanofi Pasteur SA0 sites3,200 target enrollmentStarted: May 17, 2010Last updated:
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Sanofi Pasteur SA
- Enrollment
- 3,200
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
- •1\) Aged 18 years or over on the day of inclusion
- •2\) Informed Consent Form has been signed and dated
- •3\) Able to attend all scheduled visits and to comply with all trial procedures
- •4\) For a woman, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination, or having undergone a surgical sterilization or being post\-menopausal
- •5\) Covered by health insurance or entitled to national social security depending on local regulations
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
Exclusion Criteria
- •An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
- •1\) Known pregnancy, or a positive urine pregnancy test
- •2\) Currently breastfeeding a child
- •3\) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
- •4\) Planned participation in another clinical trial during the present trial period
- •5\) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- •6\) Planned receipt of any vaccine prior to the blood sample performed 21 days after the second trial vaccination
- •7\) Previous vaccination with an H5N1 vaccine
- •8\) History of H5N1 infection or exposure to presumed/confirmed (either clinically, serologically, or microbiologically) cases of H5N1\-infected humans or animals
- •9\) Receipt of blood or blood\-derived products in the past 3 months, which might interfere with assessment of the immune response
Investigators
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