Support Annual Strain Update, Safety and Immunogenicity of an Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Subjects 18-64 Years Affected by Chronic Diseases.

Novartis

Status and phase

Completed

Phase 2

Conditions

Influenza Disease

Treatments

Biological: Adjuvanted influenza vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00522067

V70P4

2007-000964-26

Details and patient eligibility

About

This phase II, open label, is designed as a seasonal study to support annual strain update evaluating the safety, clinical tolerability and immunogenicity of the 2007-2008 formulation of Novartis Vaccines' adjuvanted, subunit influenza vaccine in adults with underlying chronic diseases

Enrollment

52 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 to 64 years of age adult volunteers, mentally competent, willing and able to give written informed consent prior to study entry, suffering from at least one of these chronic diseases: hypertension, heart disease, chronic obstructive pulmonary disease (COPD) or asthma, hepatic or renal insufficiency, arteriosclerotic disease or insulin dependent diabetes mellitus

Exclusion criteria

Hypersensitivity to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate or any other component of the vaccine;
History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
Known or suspected impairment/ alteration of immune function;
Having received within the past 12 months more than one injection of influenza vaccine
Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives