Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine

Completed · Phase 2

Conditions studied: Infections, Papillomavirus, Papillomavirus Vaccines

In brief

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate the long-term immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Key facts

Study ID

NCT00359619

Run by

GlaxoSmithKline

People needed

383

Starts

2006-09-12

Expected to finish

2007-01-30

Last updated by the study team

2020-01-02

Who can join

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

You may qualify if…

• A female who enrolled in the study 102115 and received three doses of vaccine.
• Written informed consent obtained from the subject prior to enrolment.

You may not qualify if…

• Use (or planned use during the study period) of any investigational or non-registered product or off-label use of licensed product (drug or vaccine).
• Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
• Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
• Planned administration of any HPV vaccine, other than that foreseen by the study protocol, during the study period.

Where it is running

• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Golden, Colorado, 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 — Tienen, Belgium
• GSK Investigational Site — Wilrijk, Belgium

Full record on ClinicalTrials.gov

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