Status:
COMPLETED
A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
10-18 years
Phase:
PHASE3
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).
Detailed Description
A combined Tdap (Tetanus, Diphteria, Acellular Pertussis) Vaccine Used as a Booster compared to Licensed Td (Tetanus and Diphteria) vaccine
Eligibility Criteria
Inclusion
- Healthy adolescents with history of completed routine vaccination against diphtheria, tetanus, and pertussis (DTP).
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
4116 Patients enrolled
Trial Details
Trial ID
NCT00109330
Start Date
November 1 2002
End Date
April 1 2004
Last Update
September 9 2016
Active Locations (44)
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1
GSK Investigational Site
Mesa, Arizona, United States, 85201
2
GSK Investigational Site
Tempe, Arizona, United States, 85282
3
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
4
GSK Investigational Site
Little Rock, Arkansas, United States, 72202