Study to Evaluate the Immunogenicity and the Safety of Adjuvanted Influenza Vaccine Candidates - Full Text View

Study to Evaluate the Immunogenicity and the Safety of Adjuvanted Influenza Vaccine Candidates

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00374842

Purpose

The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years

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

MedlinePlus related topics:

Flu

Drug Information available for:

Influenza Vaccines Fluvirin

U.S. FDA Resources

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 Candidates Compared to Fluarix™ Administered Intramuscularly in Subjects Aged 18-59 Years.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Immune response at days 0 and 21

Secondary Outcome Measures:

Safety during 30 days

Estimated Enrollment:	300
Study Start Date:	October 2006

Eligibility

Ages Eligible for Study:	18 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A male or female aged 18-59 years 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
Previous vaccination against influenza in 2006
Acute or chronic 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: NCT00374842

Locations


Belgium
	GSK Investigational Site
	Wilrijk, Belgium, 2610

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	108656
First Received:	September 8, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00374842
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:

RNA Virus Infections

ClinicalTrials.gov processed this record on November 06, 2008