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CompletedNCT00109330Updated Sep 9, 2016

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

A Phase 3 interventional study of Combined diphtheria, tetanus, acellular pertussis vaccine in Diphtheria, Tetanus and Acellular Pertussis, sponsored by GlaxoSmithKline. Completed at 44 sites in United States. Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-09.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
4,116
Allocation
Randomized
Ages
10 Years to 18 Years
Sex
All
01

Study summary

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).

Read the detailed description

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

02

Conditions studied

  • Diphtheria
  • Tetanus
  • Acellular Pertussis

Keywords

  • Prevention of Diphtheria, Tetanus, Pertussis
03

In context

Whooping Cough

238 studies on the registry are indexed under Whooping Cough; 15 are open to participants now.

This study's enrollment of 4,116 is above the median of 375 across 180 interventional studies indexed under Whooping Cough.

Browse Whooping Cough studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,561 studies on the registry; 116 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
4,116 participants (actual)

Interventions

  • BiologicalCombined diphtheria, tetanus, acellular pertussis vaccine
06

Study locations

44 sites
  • GSK Investigational Site
    Mesa, Arizona 85201, United States
  • GSK Investigational Site
    Tempe, Arizona 85282, United States
  • GSK Investigational Site
    Jonesboro, Arkansas 72401, United States
  • GSK Investigational Site
    Little Rock, Arkansas 72202, United States
  • GSK Investigational Site
    Escondido, California 92021, United States
  • GSK Investigational Site
    Fullerton, California 92835, United States
  • GSK Investigational Site
    Redondo Beach, California 90277, United States
  • GSK Investigational Site
    Rolling Hills Est, California 90274, United States
  • GSK Investigational Site
    Torrance, California 90502, United States
  • GSK Investigational Site
    Yorba Linda, California 92886, United States
  • GSK Investigational Site
    Boulder, Colorado 80304, United States
  • GSK Investigational Site
    Centennial, Colorado 80112, United States
  • GSK Investigational Site
    Golden, Colorado 80401, United States
  • GSK Investigational Site
    Middletown, Connecticut 06457, United States
  • GSK Investigational Site
    Norwich, Connecticut 06360, United States
  • GSK Investigational Site
    Jacksonville, Florida 32209, United States
  • GSK Investigational Site
    Chicago, Illinois 60614, United States
  • GSK Investigational Site
    Bardstown, Kentucky 40004, United States
  • GSK Investigational Site
    New Bedford, Maine 2740, United States
  • GSK Investigational Site
    Boston, Massachusetts 02115, United States
  • GSK Investigational Site
    Boston, Massachusetts 02130, United States
  • GSK Investigational Site
    Milford, Massachusetts 01757, United States
  • GSK Investigational Site
    Woburn, Massachusetts 01801, United States
  • GSK Investigational Site
    Omaha, Nebraska 68178, United States
  • GSK Investigational Site
    Whitehouse Station, New Jersey 08889, United States
  • GSK Investigational Site
    Rochester, New York 14620, United States
  • GSK Investigational Site
    Stony Brook, New York 11794, United States
  • GSK Investigational Site
    Chapel Hill, North Carolina 27514, United States
  • GSK Investigational Site
    Durham, North Carolina 27710, United States
  • GSK Investigational Site
    Lumberton, North Carolina 28358, United States
  • GSK Investigational Site
    Akron, Ohio 44308-1062, United States
  • GSK Investigational Site
    Cleveland, Ohio 44109, United States
  • GSK Investigational Site
    University Heights, Ohio 44118, United States
  • GSK Investigational Site
    Pittsburgh, Pennsylvania 15213-2583, United States
  • GSK Investigational Site
    Pittsburgh, Pennsylvania 15241, United States
  • GSK Investigational Site
    Sellersville, Pennsylvania 18960, United States
  • GSK Investigational Site
    Kingsport, Tennessee 37660, United States
  • GSK Investigational Site
    Bryan, Texas 77802, United States
  • GSK Investigational Site
    Georgetown, Texas 78626, United States
  • GSK Investigational Site
    Houston, Texas 77030, United States
  • GSK Investigational Site
    Temple, Texas 76508, United States
  • GSK Investigational Site
    Salt Lake City, Utah 84109, United States
  • GSK Investigational Site
    West Jordan, Utah 84084, United States
  • GSK Investigational Site
    Norfolk, Virginia 23510, United States
07

References and documents

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00109330
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Apr 27, 2005
Start date
Nov 2002
Primary completion
Apr 2004
Completion
Apr 2004
Last update
Sep 9, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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