Post-marketing Safety Study of GSK Biologicals' Boostrix® Vaccine
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00297856
First received: February 28, 2006
Last updated: May 2, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Prophylaxis Against Diphtheria, Tetanus, and Pertussis |
Biological: Boostrix® Biological: Td (Tetanus diphtheria) vaccine |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Open, Prospective Study of the Safety of GSK Biologicals' Boostrix® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) Administered to a Cohort of Adolescents in a US Health Maintenance Organization (HMO) |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence of medically-attended neurological events. [ Time Frame: 30 days following vaccination with Boostrix. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Occurrence of medically-attended hematologic events [ Time Frame: 30 days following vaccination with Boostrix ] [ Designated as safety issue: No ]
- Occurrence of allergic reactions. [ Time Frame: 30 days following vaccination with Boostrix ] [ Designated as safety issue: No ]
- Occurrence of new onset chronic illnesses [ Time Frame: 6-month period following vaccination with Boostrix ] [ Designated as safety issue: No ]
- Occurrence of neurological and hematological events and allergic reactions [ Time Frame: Within the second 30-day period following vaccination with Boostrix ] [ Designated as safety issue: No ]
- Occurrence of chronic illnesses in an historical control cohort of subjects vaccinated with Td vaccine [ Designated as safety issue: No ]
| Enrollment: | 10000 |
| Study Start Date: | March 2006 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Boostrix cohort
Not Applicable
|
Biological: Boostrix®
Single dose
|
|
Historical Td cohort
Not Applicable
|
Biological: Td (Tetanus diphtheria) vaccine
Single dose
|
Detailed Description:
Data collection through utilization of automated databases at the study site. The collaborator is Kaiser Permanente Vaccine Study Center.
Eligibility| Ages Eligible for Study: | 10 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
Subjects enrolled in the Northern California Kaiser-Permanente Health Care Plan
Criteria
Inclusion Criteria:
- Subjects between the age of 10 and 18 years (inclusive) who received a dose of Boostrix and who have safety follow-up information available
Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00297856 History of Changes |
| Other Study ID Numbers: | 104154 |
| Study First Received: | February 28, 2006 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
Boostrix |
Additional relevant MeSH terms:
|
Diphtheria Whooping Cough Tetanus Tetany Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bordetella Infections Gram-Negative Bacterial Infections Respiratory Tract Infections |
Infection Respiratory Tract Diseases Clostridium Infections Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Hypocalcemia Calcium Metabolism Disorders Metabolic Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013