Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older Adults - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00380211

Purpose

The purpose of this trial is to describe the immunogenicity, the safety, and tolerability of FluLaval™ TR and Fluarix®, the latter serving as active comparator. The results will be compared to a standard immune response criteria, for both young and elderly populations.

Condition	Intervention	Phase
Influenza	Biological: Influenza vaccine (A/H3N2, A/H1N1, and B strains) Biological: Fluarix	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind Trial Evaluating the Safety and Immunogenicity of an Influenza Vaccine With Reduced Preservative (FluLaval™ TR) and a Standard Influenza Vaccine (Fluarix®) in Subjects Between 18-60 and Over 60 Years of Age.

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:

21 days after vaccination: seroconversion rate, seroprotection rate,
geometric mean titer fold increase

Secondary Outcome Measures:

Immediate AEs; solicited and spontaneous AEs within 42 days of vaccination;
SAEs over the whole study period

Estimated Enrollment:	600
Study Start Date:	September 2006

Detailed Description:

This randomized trial will assess the immune protection offered at Day 21 by FluLaval™ TR, Fluarix® being the comparator. In both groups, immune response will be assessed through a blood test before and 21 days following vaccination. The safety and tolerability of the study vaccine will be contrasted to the comparator vaccine over a period of 42 days following vaccination.

Eligibility

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

Criteria

Inclusion Criteria:

Male or female adults (≥18 yrs)
Stable health status
Provide informed consent
Access to direct phone service (NOT a pay phone or a common-use phone service)
Eligible females must have a negative pregnancy test

Exclusion Criteria:

Febrile illness (>38.0°C oral temperature)
High blood pressure (≥140/90 mmHg)
Significant acute or chronic
Uncontrolled medical or psychiatric illness within 1 month prior to vaccination
Immunosuppressive condition (confirmed or suspected)
Renal impairment
Hepatic dysfunction
Complicated insulin-dependent diabetes mellitus
Unstable cardiopulmonary disease
Blood dyscrasias
Cytotoxic, immunosuppressive drug, or glucocorticoids use within 1 month of vaccination (nasal glucocorticoids allowed)
History of demyelinating disease
Active neurological disorder
Significant alcohol or drug abuse
Significant coagulation disorder (prophylactic antiplatelet medications allowed)
Influenza vaccine administrated within 6 months prior to study vaccination
Administration of any other vaccine from 30 days prior to the end of the study
Use of non-registered drug within 30 days prior to study vaccination
Receipt of immunoglobulins and/or any blood products within 3 months of study vaccination
History or suspected allergy to previous influenza vaccine, or to any constituent of FluLaval™ TR and Fluarix®, or reaction to eggs consumption
Pregnant or nursing female subjects
Female subjects not protected by an acceptable contraception method (except if surgically sterile or post-menopausal)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380211

Locations

United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33173
United States, Kansas
GSK Investigational Site
Lenexa, Kansas, United States, 66219
United States, New York
GSK Investigational Site
Binghamton, New York, United States, 13901
United States, Texas
GSK Investigational Site
Fort Worth, Texas, United States, 76135
GSK Investigational Site
Austin, Texas, United States, 78705
United States, Virginia
GSK Investigational Site
Burke, Virginia, United States, 22015

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	IDB-200-001, 109249
Study First Received:	September 21, 2006
Last Updated:	February 26, 2009
ClinicalTrials.gov Identifier:	NCT00380211 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Influenza vaccine
Thimerosal reduced content
Young and elderly adults
Immunogenicity, safety, reactogenicity

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 November 09, 2009