Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to Elderly Subjects

Novartis

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008

Study type: Interventional

Funder types: Industry

Identifiers

NCT00522236

2007-000966-19

V70P5S

Details and patient eligibility

About

To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over

Enrollment: 56 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 65 years of age or older

Exclusion criteria

• any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or insulin-dependent 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 kanamycin 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
• any acute disease or infections requiring systemic antibiotic or antiviral therapy within the past 7 days
• fever within the past 3 days

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Biological: Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008