Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults - Full Text View

Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00385255

Purpose

The current study will provide information for the use of Boostrix concomitantly with influenza vaccine in adults aged 19-64 years. This study will also provide safety and immunogenicity data in a cohort of adults aged greater than or equal to 65 years.

Condition	Intervention	Phase
Diphtheria Tetanus Pertussis Influenza	Biological: Tetanus toxoid,reduced diphtheria toxoid&acellular pertussis	Phase III

MedlinePlus related topics:

Diphtheria Flu Tetanus Whooping Cough

Drug Information available for:

Tetanus Vaccine Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Study to Evaluate Immunogenicity and Safety of Boostrix When co-Administered With Fluarix in Subjects 19 Years of Age and Older

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Antibody concentrations to all vaccine antigens.
Solicited & unsolicited symptoms, SAEs

Estimated Enrollment:	1800
Study Start Date:	October 2006

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male or female adults aged between 19 to 64 years, inclusive for the primary cohort), or aged 65 years or older (for the exploratory cohort), at the time of vaccination.

Exclusion Criteria:

Administration of an influenza vaccine within six months prior to study entry
Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.
Administration of a Tdap vaccine at any time prior to study entry.
Administration of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding vaccination, or planned use during the entire study period.
History of diphtheria and/or tetanus and/or pertussis disease.
History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or influenza vaccine or any component of the study vaccines.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385255

Locations


United States, Alabama
	GSK Investigational Site
	Huntsville, Alabama, United States, 35802

United States, Arizona
	GSK Investigational Site
	Phoenix, Arizona, United States, 85014
	GSK Investigational Site
	Mesa, Arizona, United States, 85213
	GSK Investigational Site
	Chandler, Arizona, United States, 85224

United States, Florida
	GSK Investigational Site
	Inverness, Florida, United States, 34452
	GSK Investigational Site
	Melbourne, Florida, United States, 32935
	GSK Investigational Site
	Pembroke Pines, Florida, United States, 33024

United States, Illinois
	GSK Investigational Site
	Peoria, Illinois, United States, 61602

United States, Pennsylvania
	GSK Investigational Site
	Pittsburgh, Pennsylvania, United States, 15217
	GSK Investigational Site
	Pittsburgh, Pennsylvania, United States, 15220

United States, Tennessee
	GSK Investigational Site
	Bristol, Tennessee, United States, 37620

United States, Texas
	GSK Investigational Site
	Houston, Texas, United States, 77024

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	106323
First Received:	October 6, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00385255
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Immunogenicity,

Co-administration,

Tdap,

Influenza

Study placed in the following topic categories:

Bacterial Infections

Whooping Cough

Cough

Diphtheria

Orthomyxoviridae Infections

Tetanus

Whooping cough

Gram-Negative Bacterial Infections

Virus Diseases

Gram-Positive Bacterial Infections

Respiratory Tract Infections

Respiratory Tract Diseases

Influenza, Human

Additional relevant MeSH terms:

Bordetella Infections

RNA Virus Infections

Corynebacterium Infections

Infection

Actinomycetales Infections

ClinicalTrials.gov processed this record on October 29, 2008