Status:
COMPLETED
Safety and Immunogenicity of Two Doses of a Tetravalent Influenza Vaccine in Adults Aged 18 Years and Above
Lead Sponsor:
Novartis Vaccines
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Evaluate the immune response and reactogenicity of H5N1 vaccination in adults aged 18 years and above (as part of a tetravalent vaccine)
Eligibility Criteria
Inclusion
- Healthy subjects (aged 18 years and above) who have signed an informed consent form
Exclusion
- Any acute or chronic illness
- Receipt of seasonal influenza vaccine for the current season 2007/2008
- Known or suspected impairment/alteration of immune function
- Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
- Any serious disease
- Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein,neomycin or kanamycin or any other component of the study vaccine
- Receipt of blood, blood products or immunoglobulins 3 months prior to vaccination
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
601 Patients enrolled
Trial Details
Trial ID
NCT00620815
Start Date
November 1 2007
End Date
December 1 2008
Last Update
March 28 2016
Active Locations (2)
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1
ATRIUM Gesundheitszentrum;
Holzkirchen, Germany, 83607
2
International Medicine & Public Health Dept. of Infect. Diseases
Munich, Germany, 80799