Status:
COMPLETED
Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio HPV-16/18
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Papillomavirus
Eligibility:
FEMALE
10-25 years
Phase:
PHASE3
Brief Summary
Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can in...
Eligibility Criteria
Inclusion
- A woman between, and including, 10 and 25 years of age at the time of the first vaccination.
- Written informed consent from the subject prior to enrolment.
- Subject must be free of obvious health problems.
- Subject must have negative urine pregnancy test.
Exclusion
- Pregnant or breastfeeding.
- Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality.
- History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease.
- Previous vaccination against human papillomavirus (HPV).
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
770 Patients enrolled
Trial Details
Trial ID
NCT00169494
Start Date
September 1 2004
End Date
July 1 2005
Last Update
September 12 2016
Active Locations (17)
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1
GSK Investigational Site
Koebenhavn NV, Denmark, 2400
2
GSK Investigational Site
Odense C, Denmark, 5000
3
GSK Investigational Site
Tallinn, Estonia, 1162
4
GSK Investigational Site
Tartu, Estonia, 50417