Status:
COMPLETED
Safety and Immunogenicity of an Adjuvanted Influenza Vaccine in Subjects Aged 65 Years and Over.
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Influenza
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of an adjuvanted influenza vaccine in elderly subjects.
Eligibility Criteria
Inclusion
- 65 years of age or older and in good health
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.
- any acute disease or infections requiring systemic antibiotic or antiviral therapy
- 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 within the past 7 days
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00316628
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