Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate

This study has been completed.

First Received: August 7, 2006 Last Updated: October 9, 2008 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00363077

Purpose

The purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above

Condition	Intervention	Phase
Influenza	Biological: Low dose adjuvanted influenza vaccine	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of Adjuvanted Influenza Vaccine Candidate Compared to Fluarix™ (GlaxoSmithKline Biologicals) Administered Intramuscularly in Elderly Aged 60 Years and Older.

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Immune response at days 0 and 21

Secondary Outcome Measures:

Immune response at days 0 and 21
Safety during 30 days

Estimated Enrollment:	150
Study Start Date:	October 2006
Study Completion Date:	November 2006

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study.
A male or female 60 years or older at the time of the first vaccination.
Free of obvious health problems

Exclusion Criteria:

Use of non-registered products
Administration of immune-modifying drugs.
Administration of vaccine 30 days before enrolment in study.
Immunosuppressive or immunodeficient condition.
Hypersensitivity to a previous dose of influenza vaccine
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
History of confirmed influenza infection within the last 12 Months.
Acute disease at the time of enrolment/vaccination.
History of allergy or reactions likely to be exacerbated by any component of the vaccine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363077

Locations

Belgium
GSK Investigational Site
Gent, Belgium, 9000

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	107975
Study First Received:	August 7, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00363077 History of Changes
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by GlaxoSmithKline:

Influenza vaccine
Prophylaxis Influenza vaccine

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on September 02, 2009