Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2337 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-13

Study Completion Date

2007-03-07

Brief Summary

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GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has recently issued provisional recommendations for universal adult Tdap vaccination. The current study will provide pivotal data in support of extending the age range for Boostrix vaccine to include adults 19-64 years of age.

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Detailed Description

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Conditions

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Acellular Pertussis Diphtheria Tetanus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Boostrix Group

Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.

Group Type EXPERIMENTAL

Boostrix™

Intervention Type BIOLOGICAL

Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine

Adacel Group

Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.

Group Type EXPERIMENTAL

ADACEL®

Intervention Type BIOLOGICAL

Sanofi Pasteur

Interventions

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Boostrix™

Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine

Intervention Type BIOLOGICAL

ADACEL®

Sanofi Pasteur

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* A healthy male or female, 19 to 64 years of age (not having reached the 65th birthday) at the time of study vaccination.

Exclusion Criteria

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding administration of study vaccine, or planned use during the active phase of the study.
* Chronic administration of immunosuppressants or within six months prior to administration of study vaccine.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of study vaccine (with the exception of an influenza vaccine).
* Administration of a diphtheria-tetanus (Td) booster within previous five years.
* Administration of Tdap vaccine at any time prior to study entry. History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or any component of the study vaccines.

Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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

Huntsville, Alabama, United States

Site Status

GSK Investigational Site

Chandler, Arizona, United States

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GSK Investigational Site

Mesa, Arizona, United States

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GSK Investigational Site

Mesa, Arizona, United States

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GSK Investigational Site

Peoria, Arizona, United States

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GSK Investigational Site

Phoenix, Arizona, United States

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GSK Investigational Site

Tempe, Arizona, United States

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GSK Investigational Site

Little Rock, Arkansas, United States

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GSK Investigational Site

San Diego, California, United States

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GSK Investigational Site

San Diego, California, United States

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GSK Investigational Site

Colorado Springs, Colorado, United States

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GSK Investigational Site

Pueblo, Colorado, United States

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GSK Investigational Site

Washington D.C., District of Columbia, United States

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GSK Investigational Site

Melbourne, Florida, United States

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GSK Investigational Site

Miami, Florida, United States

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GSK Investigational Site

Pembroke Pines, Florida, United States

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GSK Investigational Site

Tampa, Florida, United States

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GSK Investigational Site

Boise, Idaho, United States

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GSK Investigational Site

Peoria, Illinois, United States

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GSK Investigational Site

South Bend, Indiana, United States

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GSK Investigational Site

Bardstown, Kentucky, United States

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GSK Investigational Site

Richland, Michigan, United States

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GSK Investigational Site

Kansas City, Missouri, United States

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GSK Investigational Site

St Louis, Missouri, United States

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GSK Investigational Site

Alliance, Nebraska, United States

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GSK Investigational Site

North Platte, Nebraska, United States

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GSK Investigational Site

Las Vegas, Nevada, United States

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GSK Investigational Site

Albuquerque, New Mexico, United States

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GSK Investigational Site

Hickory, North Carolina, United States

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GSK Investigational Site

Raleigh, North Carolina, United States

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GSK Investigational Site

Winston-Salem, North Carolina, United States

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GSK Investigational Site

Bismarck, North Dakota, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, United States

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GSK Investigational Site

Grove City, Pennsylvania, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, United States

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GSK Investigational Site

Bristol, Tennessee, United States

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Knoxville, Tennessee, United States

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GSK Investigational Site

Houston, Texas, United States

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GSK Investigational Site

Salt Lake City, Utah, United States

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GSK Investigational Site

Salt Lake City, Utah, United States

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GSK Investigational Site

West Jordan, Utah, United States

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GSK Investigational Site

Norfolk, Virginia, United States

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Countries

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United States

References

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Blatter M, Friedland LR, Weston WM, Li P, Howe B. Immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid and three-component acellular pertussis vaccine in adults 19-64 years of age. Vaccine. 2009 Jan 29;27(5):765-72. doi: 10.1016/j.vaccine.2008.11.028. Epub 2008 Nov 27.

Reference Type BACKGROUND

PMID: 19041352 (View on PubMed)

Study Documents

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