Status:
COMPLETED
Comparison of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diphtheria
Acellular Pertussis
Eligibility:
All Genders
4-6 years
Phase:
PHASE2
Brief Summary
The aims of this study are to compare the immunogenicity and safety of the GSK Biologicals' combined DTaP-IPV vaccine with separate administration of DTaP and IPV vaccines, when administered as a fift...
Eligibility Criteria
Inclusion
- Healthy children between and including 4 and 6 years of age.
- Previously received 4 doses of GSK Biologicals' DTaP, 3 doses of IPV vaccine and 1 dose of measles, mumps, and rubella vaccine.
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 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
401 Patients enrolled
Trial Details
Trial ID
NCT00263692
Start Date
November 1 2002
End Date
September 1 2004
Last Update
September 15 2016
Active Locations (15)
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1
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
2
GSK Investigational Site
Fountain Valley, California, United States, 92708
3
GSK Investigational Site
Oakland, California, United States, 94612
4
GSK Investigational Site
Torrance, California, United States, 90502