Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two(Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines in Non-Elderly Adult and Elderly Subjects

Novartis

Status and phase

Completed

Phase 2

Conditions

Pandemic Influenza Disease

Treatments

Biological: Influenza vaccine surface antigen adjuvanted with MF59

Study type

Interventional

Funder types

Industry

Identifiers

NCT00311480

Eudract:2005-005871-14

V87P1

Details and patient eligibility

About

The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, in non-elderly adult and elderly subjects.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female volunteers 18 years of age or older

Exclusion criteria

any auto-immune disease or other serious acute, chronic or progressive disease
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.
within the past 7 days, they have experienced: any acute disease, infections requiring systemic antibiotic or antiviral therapy.