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Pre-licensure studies of GSK Biologicals' Boostrix® have shown it to be generally safe and well-tolerated. This post-licensure study is designed to evaluate relatively uncommon/rare outcomes in a large population cohort. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Data collection through utilization of automated databases at the study site. The collaborator is Kaiser Permanente Vaccine Study Center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boostrix cohort |
| ||
| Historical Td cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boostrix® | Biological | Single dose |
| |
| Td (Tetanus diphtheria) vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of medically-attended neurological events. | 30 days following vaccination with Boostrix. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of medically-attended hematologic events | 30 days following vaccination with Boostrix | |
| Occurrence of allergic reactions. | 30 days following vaccination with Boostrix | |
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Inclusion Criteria:
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Subjects enrolled in the Northern California Kaiser-Permanente Health Care Plan
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Oakland | California | 94612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20190673 | Background | Klein NP, Hansen J, Lewis E, Lyon L, Nguyen B, Black S, Weston WM, Wu S, Li P, Howe B, Friedland LR. Post-marketing safety evaluation of a tetanus toxoid, reduced diphtheria toxoid and 3-component acellular pertussis vaccine administered to a cohort of adolescents in a United States health maintenance organization. Pediatr Infect Dis J. 2010 Jul;29(7):613-7. doi: 10.1097/INF.0b013e3181d581f9. |
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| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| C505143 | Boostrix |
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Biological |
Single dose |
|
| Occurrence of new onset chronic illnesses |
| 6-month period following vaccination with Boostrix |
| Occurrence of neurological and hematological events and allergic reactions | Within the second 30-day period following vaccination with Boostrix |
| Occurrence of chronic illnesses in an historical control cohort of subjects vaccinated with Td vaccine |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |