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

This study has been completed.

First Received: August 28, 2007 No Changes Posted

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00522067

Purpose

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

Condition	Intervention	Phase
Influenza Disease	Biological: Adjuvanted influenza vaccine	Phase II

MedlinePlus related topics: Coping with Chronic Illness Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Open Label, Uncontrolled, Multi-Center Study to Support Annual Strain Update and to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Subjects Aged 18-64 Years Affected by Chronic Diseases

Further study details as provided by Novartis:

Primary Outcome Measures:

Evaluate the antibody response to each flu vacc. antigen, measured by SRH at 21-day post-vacc. in at risk adults in compliance with the requirements of the EU recommendations for the evaluation of the immunog. for a new formulation of a licensed flu vacc
To evaluate the safety of the administration of a single intarmuscolar (IM)injection of an inactivated, adjuvanted influenza vaccine, in at risk adult subjects.

Estimated Enrollment:	63
Study Start Date:	June 2007

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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, kanamicyn 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522067

Locations

Italy
Azienda Sanitaria USL 7 di Siena
Siena, Italy, 53100

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines

More Information

No publications provided

Study ID Numbers:	V70P4, 2007-000964-26
Study First Received:	August 28, 2007
Last Updated:	August 28, 2007
ClinicalTrials.gov Identifier:	NCT00522067 History of Changes
Health Authority:	Italy: Ministry of Health

Keywords provided by Novartis:

influenza
influenza vaccine
adjuvanted influenza vaccine
subunit influenza vaccine
surface antigen

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Chronic Disease
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Chronic Disease
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009