Status:
COMPLETED
Assessment of GSK Biologicals' Tdap Candidate Vaccine Administered as a Booster (6th Dose) in Terms of Immunogenicity and Safety to Children and Adolescents Previously Vaccinated With Five Doses of an Acellular Pertussis-containing Vaccine.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Acellular Pertussis
Diphtheria
Eligibility:
All Genders
9-13 years
Phase:
PHASE3
Brief Summary
The aims of this study are to evaluate the safety and immunogenicity of a booster dose of GSK Biological's candidate Tdap vaccine containing 0.3 mg Al when administered to healthy school children and ...
Eligibility Criteria
Inclusion
- \- Subjects previously enrolled and vaccinated in GSK Biologicals' studies APV-118 and APV-120 and who were 9 through 13 years of age
Exclusion
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.
- Chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period
- Administration of immunoglobulins and/or blood products within 3 months prior to vaccination
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT00263679
Start Date
November 1 2003
End Date
October 1 2004
Last Update
September 15 2016
Active Locations (13)
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1
GSK Investigational Site
Kehl, Baden-Wurttemberg, Germany, 77694
2
GSK Investigational Site
Oberkirch, Baden-Wurttemberg, Germany, 77704
3
GSK Investigational Site
Limburg an der Lahn, Hesse, Germany, 65549
4
GSK Investigational Site
Erkrath, North Rhine-Westphalia, Germany, 40699