Status:
COMPLETED
Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Acellular Pertussis
Diphtheria
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
The current study will provide information for the use of Boostrix concomitantly with influenza vaccine in adults aged 19-64 years. This study will also provide safety and immunogenicity data in a coh...
Eligibility Criteria
Inclusion
- Healthy male or female adults aged between 19 to 64 years, inclusive for the primary cohort), or aged 65 years or older (for the exploratory cohort), at the time of vaccination.
Exclusion
- Administration of an influenza vaccine within six months prior to study entry
- Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.
- Administration of a Tdap vaccine at any time prior to study entry.
- Administration of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding vaccination, or planned use during the entire study period.
- History of diphtheria and/or tetanus and/or pertussis disease.
- History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or influenza vaccine or any component of the study vaccines.
Key Trial Info
Start Date :
October 23 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2007
Estimated Enrollment :
1726 Patients enrolled
Trial Details
Trial ID
NCT00385255
Start Date
October 23 2006
End Date
February 28 2007
Last Update
June 10 2019
Active Locations (12)
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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, 85213
4
GSK Investigational Site
Phoenix, Arizona, United States, 85014