Status:
COMPLETED
Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years
Lead Sponsor:
GlaxoSmithKline
Conditions:
Acellular Pertussis
Diphtheria
Eligibility:
All Genders
19-64 years
Phase:
PHASE3
Brief Summary
GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has recently issued provision...
Eligibility Criteria
Inclusion
- A healthy male or female, 19 to 64 years of age (not having reached the 65th birthday) at the time of study vaccination.
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding administration of study vaccine, or planned use during the active phase of the study.
- Chronic administration of immunosuppressants or within six months prior to administration of study vaccine.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of study vaccine (with the exception of an influenza vaccine).
- Administration of a diphtheria-tetanus (Td) booster within previous five years.
- Administration of Tdap vaccine at any time prior to study entry. History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or any component of the study vaccines.
Key Trial Info
Start Date :
July 13 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2007
Estimated Enrollment :
2337 Patients enrolled
Trial Details
Trial ID
NCT00346073
Start Date
July 13 2006
End Date
March 7 2007
Last Update
August 7 2018
Active Locations (42)
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1
GSK Investigational Site
Huntsville, Alabama, United States, 35802
2
GSK Investigational Site
Chandler, Arizona, United States, 85224
3
GSK Investigational Site
Mesa, Arizona, United States, 85203
4
GSK Investigational Site
Mesa, Arizona, United States, 85213