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Home > Protocol Summaries: Compounds > Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine > Protocol Summary for 104154

Protocol Summary for 104154

Protocol Summary
Protocol Id: 104154
Secondary Ids:
  • N/A
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)
Phase: phase 4
Acronym:
FDA Regulated Intervention?: Yes
Section 801 Clinical Trial?: Yes
Delayed Posting: No
IND/IDE Protocol?: yes
IND/IDE Grantor: CBER
IND/IDE Number: BB-IND 8461
IND/IDE Serial Number: NA
Has Expanded Access?: no
Study Type: Observational
Oversight Authority:
  • United States: Food and Drug Administration
Collaborators:
  • N/A
Brief Summary: 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.
Detailed Description: Data collection through utilization of automated databases at the study site. The collaborator is Kaiser Permanente Vaccine Study Center.
Record Verification Date: April 2013
Status: Completed
Why Study Stopped:
Study Start Date: March 2006
Study Completion Date: December 2006
Study Completion Date Type: Actual
Primary Completion Date: December 2006
Primary Completion Date Type: Actual
Study Design: Cohort
Time Perspective: Prospective
Biospecimen Retention: None retained
Biospecimen Description:
Primary Outcomes:
  • Occurrence of medically-attended neurological events. 30 days following vaccination with Boostrix.
Secondary Outcomes:
  • Occurrence of allergic reactions. 30 days following vaccination with Boostrix
  • 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 N/A
  • Occurrence of medically-attended hematologic events 30 days following vaccination with Boostrix
Conditions:
  • Prophylaxis against diphtheria, tetanus, and pertussis
Keywords:
  • Boostrix
Study Population: Subjects enrolled in the Northern California Kaiser-Permanente Health Care Plan
Sampling Method: Probability
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 10 Year
Maximum Age: 18 Year
Enrollment: 10000
Enrollment Type: Actual
Healthy Volunteers?: yes
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: No locations currently recruiting for this study.