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

Completed

Phase 2

Conditions

Influenza

Treatments

Biological: Surface Antigen, Inactivated, Influenza (form.2006-07)

Study type

Interventional

Funder types

Industry

Identifiers

Eudract no.2006-000609-43

V71P4S

Details and patient eligibility

About

To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 18 years and over

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 and bleeding diathesis or conditions associated with prolonged bleeding time
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 (chronic antibiotic therapy for urinary tract prophylaxis was acceptable)
fever within the past 3 days
history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
within the past 12 months have received more than one injection of influenza vaccine
Women who are pregnant or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days)