Status:
COMPLETED
Human Papilloma Virus Vaccine Safety and Immunogenicity Trial in Young Adolescent Women With GSK Bio HPV-16/18.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Papillomavirus
Eligibility:
FEMALE
10-14 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 14 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 :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
2067 Patients enrolled
Trial Details
Trial ID
NCT00196924
Start Date
June 1 2004
End Date
March 1 2006
Last Update
March 23 2017
Active Locations (61)
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1
GSK Investigational Site
North Adelaide, South Australia, Australia, 5006
2
GSK Investigational Site
Perth, Western Australia, Australia
3
GSK Investigational Site
Bogotá, Colombia, 805
4
GSK Investigational Site
Bogotá, Colombia