Tetanus Clinical Trial
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)
| Verified date | September 2016 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 4116 |
| Est. completion date | April 2004 |
| Est. primary completion date | April 2004 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 10 Years to 18 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | GSK Investigational Site | Akron | Ohio |
| United States | GSK Investigational Site | Bardstown | Kentucky |
| United States | GSK Investigational Site | Boston | Massachusetts |
| United States | GSK Investigational Site | Boston | Massachusetts |
| United States | GSK Investigational Site | Boulder | Colorado |
| United States | GSK Investigational Site | Bryan | Texas |
| United States | GSK Investigational Site | Centennial | Colorado |
| United States | GSK Investigational Site | Chapel Hill | North Carolina |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Cleveland | Ohio |
| United States | GSK Investigational Site | Durham | North Carolina |
| United States | GSK Investigational Site | Escondido | California |
| United States | GSK Investigational Site | Fullerton | California |
| United States | GSK Investigational Site | Georgetown | Texas |
| United States | GSK Investigational Site | Golden | Colorado |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Jacksonville | Florida |
| United States | GSK Investigational Site | Jonesboro | Arkansas |
| United States | GSK Investigational Site | Kingsport | Tennessee |
| United States | GSK Investigational Site | Little Rock | Arkansas |
| United States | GSK Investigational Site | Lumberton | North Carolina |
| United States | GSK Investigational Site | Mesa | Arizona |
| United States | GSK Investigational Site | Middletown | Connecticut |
| United States | GSK Investigational Site | Milford | Massachusetts |
| United States | GSK Investigational Site | New Bedford | Maine |
| United States | GSK Investigational Site | Norfolk | Virginia |
| United States | GSK Investigational Site | Norwich | Connecticut |
| United States | GSK Investigational Site | Omaha | Nebraska |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Redondo Beach | California |
| United States | GSK Investigational Site | Rochester | New York |
| United States | GSK Investigational Site | Rolling Hills Est | California |
| United States | GSK Investigational Site | Salt Lake City | Utah |
| United States | GSK Investigational Site | Sellersville | Pennsylvania |
| United States | GSK Investigational Site | Stony Brook | New York |
| United States | GSK Investigational Site | Tempe | Arizona |
| United States | GSK Investigational Site | Temple | Texas |
| United States | GSK Investigational Site | Torrance | California |
| United States | GSK Investigational Site | University Heights | Ohio |
| United States | GSK Investigational Site | West Jordan | Utah |
| United States | GSK Investigational Site | Whitehouse Station | New Jersey |
| United States | GSK Investigational Site | Woburn | Massachusetts |
| United States | GSK Investigational Site | Yorba Linda | California |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States,
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