Status:
COMPLETED
Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Cervical Intraepithelial Neoplasia
Papillomavirus Infection
Eligibility:
FEMALE
10-14 years
Phase:
PHASE3
Brief Summary
This protocol posting deals with objectives \& outcome measures of the extension phase up to Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of the HPV 16/18...
Eligibility Criteria
Inclusion
- A female who enrolled in the immunological subset of the 580299-013 study, received the three doses of vaccine/control according to the treatment allocation and completed the 580299-013 study.
- Written informed assent obtained from the subject and written informed consent obtained from a parent or legally acceptable representative of the subject.
Exclusion
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than 3 months prior to blood sampling.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding blood sampling.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
1245 Patients enrolled
Trial Details
Trial ID
NCT00316706
Start Date
October 1 2005
End Date
January 1 2009
Last Update
September 18 2012
Active Locations (28)
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1
GSK Investigational Site
Bogotá, Colombia, 805
2
GSK Investigational Site
Bogotá, Colombia
3
GSK Investigational Site
Deggingen, Baden-Wurttemberg, Germany, 73326
4
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, Germany, 77955