Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects

Novartis

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Biological: Pandemic influenza vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00434733

2006-005428-18

V87P4

Details and patient eligibility

About

This study is designed to evaluate the immunogenicity, safety and tolerability of 2 doses of FLUAD-H5N1 vaccine compared to 2 doses of trivalent, interpandemic FLUAD, each administered 3 weeks apart.

Enrollment

4,400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy Subjects 18 years of age who signed the informed consent

Exclusion criteria

Receipt of another investigational agent within 4 weeks
Receipt of influenza vaccination for current season 2006/2007.
any acute disease or infection, history of neurological symptoms or signs, known or suspected impairment of immune function, any serious disease, bleeding diathesis
fever (defined as axillary temperature ³38.0°C) within 3 days (prior to Visit 1)
Pregnant or breastfeeding or females of childbearing potential who refuse to use an acceptable method of birth control
Surgery planned during the study period
Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine
Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
History of (or current) drug or alcohol abuse
Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.