Status:
COMPLETED
Safety and Immunogenicity of a Inactivated Influenza Vaccine When Administered to Non Elderly Adults and Elderly Subjects.
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Influenza Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of a Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2005-2006, when Administer...
Eligibility Criteria
Inclusion
- subjects 18 years of age or older
Exclusion
- Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure
- 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
- known or suspected (or high risk of developing) impairment/alteration of immune function
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00316615
Start Date
June 1 2005
Last Update
September 14 2006
Active Locations (2)
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1
G. D'Annunzio University
Chieti, Italy, 66100
2
Office of Hygiene and Public Health, ASL Lanciano
Lanciano, Italy