Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older

Novartis

Status and phase

Withdrawn

Phase 2

Conditions

Influenza

Treatments

Biological: influenza surface antigen inactivated vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00342940

V78P4S

Eudract number:2006-000787-88

Details and patient eligibility

About

The present study aims to evaluate safety and immunogenicity of one dose of a commercially available Surface Antigen, Inactivated Influenza Vaccine, Formulation 2006-2007, in non-elderly adult and elderly subjects.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female subjects 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
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
history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine