Status:
COMPLETED
Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Papillomavirus
Papillomavirus Vaccines
Eligibility:
FEMALE
18-25 years
Phase:
PHASE2
Brief Summary
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb...
Eligibility Criteria
Inclusion
- A female who enrolled in the study 102115 and received three doses of vaccine.
- Written informed consent obtained from the subject prior to enrolment.
Exclusion
- Use (or planned use during the study period) of any investigational or non-registered product or off-label use of licensed product (drug or vaccine).
- Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
- Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
- Planned administration of any HPV vaccine, other than that foreseen by the study protocol, during the study period.
Key Trial Info
Start Date :
September 12 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2007
Estimated Enrollment :
383 Patients enrolled
Trial Details
Trial ID
NCT00359619
Start Date
September 12 2006
End Date
January 30 2007
Last Update
January 2 2020
Active Locations (10)
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1
GSK Investigational Site
Denver, Colorado, United States, 80262
2
GSK Investigational Site
Golden, Colorado, United States, 80401
3
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
4
GSK Investigational Site
Salt Lake City, Utah, United States, 84121