Status:
COMPLETED
Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Papillomavirus
Eligibility:
FEMALE
18-25 years
Phase:
PHASE2
Brief Summary
Human Papilloma viruses (HPV) are viruses that cause infections of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect t...
Eligibility Criteria
Inclusion
- A woman between, and including, 18 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 be of non-childbearing potential and have had no more than 6 lifetime sexual partners
Exclusion
- Pregnant or breastfeeding
- A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Month 0-8)
- 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 :
March 4 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2006
Estimated Enrollment :
383 Patients enrolled
Trial Details
Trial ID
NCT00231413
Start Date
March 4 2005
End Date
March 27 2006
Last Update
December 12 2019
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Aurora, Colorado, United States, 80045
2
GSK Investigational Site
Golden, Colorado, United States, 80401
3
GSK Investigational Site
Kingston, Rhode Island, United States, 02881
4
GSK Investigational Site
Salt Lake City, Utah, United States, 84109