A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td Vaccine

NCT ID: NCT00109330

Last Updated: 2016-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2004-04-30

Brief Summary

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This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine compared to licensed Td vaccine when used as a booster in healthy adolescents (10-18 years of age).

Detailed Description

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A combined Tdap (Tetanus, Diphteria, Acellular Pertussis) Vaccine Used as a Booster compared to Licensed Td (Tetanus and Diphteria) vaccine

Conditions

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Diphtheria Tetanus Acellular Pertussis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Combined diphtheria, tetanus, acellular pertussis vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy adolescents with history of completed routine vaccination against diphtheria, tetanus, and pertussis (DTP).

Exclusion Criteria

* Use of any other investigational drug or vaccine 30 days preceding study vaccination.
* Chronic administration of immunosuppressants.
* Administration of pre-school DTP vaccine within previous 5 years.
* Administration of Td booster within previous 10 years.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Mesa, Arizona, United States

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Tempe, Arizona, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Escondido, California, United States

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Fullerton, California, United States

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Redondo Beach, California, United States

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Rolling Hills Est, California, United States

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Torrance, California, United States

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Yorba Linda, California, United States

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Boulder, Colorado, United States

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Centennial, Colorado, United States

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Golden, Colorado, United States

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Middletown, Connecticut, United States

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Norwich, Connecticut, United States

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Jacksonville, Florida, United States

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Chicago, Illinois, United States

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Bardstown, Kentucky, United States

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New Bedford, Maine, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Milford, Massachusetts, United States

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Woburn, Massachusetts, United States

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Omaha, Nebraska, United States

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Whitehouse Station, New Jersey, United States

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Rochester, New York, United States

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Stony Brook, New York, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Lumberton, North Carolina, United States

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Akron, Ohio, United States

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Cleveland, Ohio, United States

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University Heights, Ohio, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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Kingsport, Tennessee, United States

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Bryan, Texas, United States

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Georgetown, Texas, United States

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Houston, Texas, United States

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Temple, Texas, United States

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Salt Lake City, Utah, United States

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West Jordan, Utah, United States

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Norfolk, Virginia, United States

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Countries

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United States

Study Documents

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Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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776423/001

Identifier Type: -

Identifier Source: org_study_id

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