A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td Vaccine
A Phase III, Observer-blinded Randomised, Multi-centre Clinical Study of the Safety, Immunogenicity and Consistency of Three Manufacturing Lots of GSK Biologicals' Candidate Tdap Vaccine as Compared to a US-licensed Td Vaccine When Given as a Booster Dose to Healthy Adolescents (10-18 Years of Age)
1 other identifier
interventional
4,116
1 country
44
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2002
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 27, 2005
CompletedFirst Posted
Study publicly available on registry
April 27, 2005
CompletedSeptember 9, 2016
September 1, 2016
1.4 years
April 27, 2005
September 8, 2016
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adolescents with history of completed routine vaccination against diphtheria, tetanus, and pertussis (DTP).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (44)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2005
First Posted
April 27, 2005
Study Start
November 1, 2002
Primary Completion
April 1, 2004
Study Completion
April 1, 2004
Last Updated
September 9, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.