Status:
COMPLETED
Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Papillomavirus
Papillomavirus Vaccines
Eligibility:
FEMALE
18-25 years
Phase:
PHASE3
Brief Summary
Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time t...
Eligibility Criteria
Inclusion
- A female subject between, and including, 18 and 25 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject prior to enrolment.
- Subject must have a negative urine pregnancy test.
- Healthy subject before entering the study entry as established by medical history and physical examination.
- Subject must be of non-childbearing potential.
Exclusion
- pregnant or breastfeeding subject.
- previous vaccination against human papillomavirus (HPV).
- Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality.
- History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes or autoimmune disease.
Key Trial Info
Start Date :
October 28 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
798 Patients enrolled
Trial Details
Trial ID
NCT00250276
Start Date
October 28 2005
End Date
March 1 2007
Last Update
January 2 2020
Active Locations (8)
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1
GSK Investigational Site
Hvidovre, Denmark, DK-2650
2
GSK Investigational Site
Kaunas, Lithuania, LT-50009
3
GSK Investigational Site
Klaipėda, Lithuania, LT-93200
4
GSK Investigational Site
Vilnius, Lithuania, LT-07156