Status:
COMPLETED
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Elderly Subjects
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Influenza
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over
Eligibility Criteria
Inclusion
- 65 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 and bleeding diathesis or conditions associated with prolonged bleeding time
- 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
- any acute disease or infections requiring systemic antibiotic or antiviral therapy fever within the past 3 days
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00329927
Start Date
June 1 2006
Last Update
September 14 2006
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
Via Dei Vestini, Chieti, Italy, 66100
2
Ufficio Igiene e Sanità Pubblica di Lanciano, Via S. Spaventa, 37
Lanciano, Italy