Safety and Immunogenicity of an Adjuvanted Influenza Vaccine in Subjects Aged 65 Years and Over.

Novartis

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: influenza vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00316628

V70P3S

Eudract number: 2005-000621-38

Details and patient eligibility

About

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.

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 65 years of age or older and in good health

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)