Last updated: 11/03/2018 00:30:34
Post-marketing safety study of GSK Biologicals' Boostrix® vaccine
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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)
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of medically-attended neurological events.
Timeframe: 30 days following vaccination with Boostrix.
Secondary outcomes:
Occurrence of medically-attended hematologic events
Timeframe: 30 days following vaccination with Boostrix
Occurrence of allergic reactions.
Timeframe: 30 days following vaccination with Boostrix
Occurrence of new onset chronic illnesses
Timeframe: 6-month period following vaccination with Boostrix
Occurrence of neurological and hematological events and allergic reactions
Timeframe: 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
Timeframe: N/A
Interventions:
Biological/vaccine: Boostrix®
Biological/vaccine: Td (Tetanus diphtheria) vaccine
Enrollment:
10000
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Klein NP et al. (2010) 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. 29(1):613–617.
Medical condition
Diphtheria, Tetanus, acellular pertussis
Product
SB776423
Collaborators
Not applicable
Study date(s)
March 2006 to December 2006
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
10 - 18 years
Accepts healthy volunteers
Yes
- 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
Inclusion and exclusion criteria
Inclusion 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
Trial location(s)
Location
GSK Investigational Site
Oakland, California, United States, 94612
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2006-29-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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