Persistence Study of GSK Bio's Tdap Vaccine 1, 3, 5 and 10 Years After Administration as a Single Dose in 106316 Study - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00489970

Purpose

This protocol posting deals with objectives & outcome measures of the extension phase at years 1, 3 5 and 10. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00346073 ) This study will provide information regarding the persistence of antibodies to diphtheria toxoid, tetanus toxoid, and acellular pertussis antigens, up to 10 years following vaccination with GSK Bio's tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed.

Condition	Intervention
Diphtheria Tetanus Pertussis	Biological: Tdap

Genetics Home Reference related topics: ataxia-telangiectasia

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Phase IIIb, Controlled, Multicenter Study to Evaluate Antibody Persistence at 1, 3, 5 and 10 Years Following Administration of a Single Dose of Tdap Vaccine to Healthy Subjects, 19 Years of Age and Older in the Study 106316

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment:	1941
Study Start Date:	June 2007
Study Completion Date:	September 2007

Detailed Description:

Non-interventional, observational unblinded multicenter with the same two parallel groups as in the 106316 study. No treatment is planned to be given in this study. Subjects in the 106316 study were randomized into treatment groups, (2:1 ratio) with stratified age group of 19-29, 30-49, and 50-64 years old). Blood samples will be collected at the following time points: 1 year, 3 years, 5 years and 10 years after the dose of vaccination.

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects must have received study vaccination in study 106316 to be considered eligible to participate in this study.
Written informed consent must be obtained from the subject prior to each study time point.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489970

Show 37 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	110080, 110082, 110084, 110086
Study First Received:	June 21, 2007
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00489970
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Persistence
immunogenicity

Study placed in the following topic categories:

Bacterial Infections
Ataxia-Telangiectasia
Whooping Cough
Cough
Diphtheria
Healthy
Tetanus
Whooping cough

Gram-Negative Bacterial Infections
Antibodies
Gram-Positive Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Ataxia Telangiectasia
Immunoglobulins

Additional relevant MeSH terms:

Bordetella Infections
Corynebacterium Infections
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009