Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years
Status: | Completed |
---|---|
Conditions: | Infectious Disease, Infectious Disease, Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 19 - 64 |
Updated: | 8/9/2018 |
Start Date: | July 13, 2006 |
End Date: | March 7, 2007 |
A Study to Evaluate Immunogenicity and Safety of Boostrix Compared to Adacel When Administered as a Booster Vaccination in Adults Aged 19 to 64 Years of Age
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 provisional recommendations for universal adult Tdap vaccination. The current
study will provide pivotal data in support of extending the age range for Boostrix vaccine to
include adults 19-64 years of age.
Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has
recently issued provisional recommendations for universal adult Tdap vaccination. The current
study will provide pivotal data in support of extending the age range for Boostrix vaccine to
include adults 19-64 years of age.
Inclusion Criteria:
- A healthy male or female, 19 to 64 years of age (not having reached the 65th birthday)
at the time of study vaccination.
Exclusion Criteria:
- 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.
We found this trial at
39
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