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

This study has been completed.

First Received on February 12, 2007. Last Updated on April 23, 2008 History of Changes

Sponsor:	Novartis
Collaborator:	Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00434733

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: Pandemic influenza vaccine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention
Official Title:	A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects

Resource links provided by NLM:

MedlinePlus related topics: Bird Flu Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Adverse event rate

Secondary Outcome Measures:

Seroconversion and seroprotection after two doses of H5N1 vaccine

Estimated Enrollment:	4400
Study Start Date:	January 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434733

Locations

Poland
Centrum Badań Farmakologii Klinicznej monipol
Kraków, Poland, 30-969

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines and Diagnostics GmbH & Co KG Novartis

Novartis Vaccines and Diagnostics GmbH & Co KG., Germany

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00434733 History of Changes
Other Study ID Numbers:	V87P4, 2006-005428-18
Study First Received:	February 12, 2007
Last Updated:	April 23, 2008
Health Authority:	Poland: Central Register of Clinical Trials (CEBK)

Keywords provided by Novartis:

Influenza H5N1, pandemic

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012