Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.

Completed · Phase 2

Conditions studied: Infections, Papillomavirus

In brief

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 the cervix (part of the uterus or womb). This infection, if it persists, can lead over a long period of time to cancer of the cervix in women. In collaboration with MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating novel HPV vaccine formulations.This study will evaluate the immunogenicity and safety of a novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately 376 study subjects will receive the novel HPV vaccine or the control vaccine administered intramuscularly according to a 0-1-6 month schedule.

Key facts

Study ID

NCT00231413

Run by

GlaxoSmithKline

People needed

383

Starts

2005-03-04

Expected to finish

2006-03-27

Last updated by the study team

2019-12-12

Who can join

Age: 18 and older, up to 25. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• GSK Investigational Site — Aurora, Colorado, United States
• GSK Investigational Site — Golden, Colorado, United States
• GSK Investigational Site — Kingston, Rhode Island, United States
• GSK Investigational Site — Salt Lake City, Utah, United States
• GSK Investigational Site — Salt Lake City, Utah, United States
• GSK Investigational Site — Brussels, Belgium
• GSK Investigational Site — Ghent, Belgium
• GSK Investigational Site — Leuven, Belgium
• GSK Investigational Site — Liège, Belgium
• GSK Investigational Site — Roeselare, Belgium
• GSK Investigational Site — Wilrijk, Belgium

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.