Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
A combined Tdap (Tetanus, Diphteria, Acellular Pertussis) Vaccine Used as a Booster compared to Licensed Td (Tetanus and Diphteria) vaccine
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined diphtheria, tetanus, acellular pertussis vaccine | Biological |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mesa | Arizona | 85201 | United States | ||
| GSK Investigational Site |
Not provided
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 776423/001 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
For additional information about this study please refer to the GSK Clinical Study Register |
| 776423/001 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 776423/001 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 776423/001 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 776423/001 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 776423/001 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided