Clinical trial NCT00109330: A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td Vaccine
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Acellular Pertussis
Keywords: Prevention of Diphtheria, Tetanus, Pertussis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-04-27
Enrollment: 4116
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tempe
country: United States
facility: GSK Investigational Site
state: Arizona
city: Jonesboro
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Escondido
country: United States
facility: GSK Investigational Site
state: California
city: Fullerton
country: United States
facility: GSK Investigational Site
state: California
city: Redondo Beach
country: United States
facility: GSK Investigational Site
state: California
city: Rolling Hills Est
country: United States
facility: GSK Investigational Site
state: California
city: Torrance
country: United States
facility: GSK Investigational Site
state: California
city: Yorba Linda
country: United States
facility: GSK Investigational Site
state: California
city: Boulder
country: United States
facility: GSK Investigational Site
state: Colorado
city: Centennial
country: United States
facility: GSK Investigational Site
state: Colorado
city: Golden
country: United States
facility: GSK Investigational Site
state: Colorado
city: Middletown
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Norwich
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Bardstown
country: United States
facility: GSK Investigational Site
state: Kentucky
city: New Bedford
country: United States
facility: GSK Investigational Site
state: Maine
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Milford
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Woburn
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Whitehouse Station
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Stony Brook
country: United States
facility: GSK Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Lumberton
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Akron
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: University Heights
country: United States
facility: GSK Investigational Site
state: Ohio
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Sellersville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Kingsport
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Bryan
country: United States
facility: GSK Investigational Site
state: Texas
city: Georgetown
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Temple
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: West Jordan
country: United States
facility: GSK Investigational Site
state: Utah
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: