Status:
COMPLETED
Comparative Trial Evaluating Safety and Immunogenicity of an Adjuvanted and a Conventional Influenza Vaccine in Elderly Subjects (> 60 Years)
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Vaccines
Chiron s.r.l. Beijing Representative Office
Conditions:
Influenza
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
Clinical Trial in Two parts: Part 1: Phase I, Open-Label, Single-Center Study to Evaluate the Safety of an adjuvanted Influenza Vaccine When Administered to Elderly Subjects. Part 2: A Phase III, Ra...
Eligibility Criteria
Inclusion
- Subjects 60 years of age or older, mentally competent, willing and able to give the written informed consent prior to study entry
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 have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age).
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00310648
Start Date
January 1 2006
Last Update
September 14 2006
Active Locations (1)
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1
Nanning
Guangxi, China, 530021