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NCT00120848 · ClinicalTrials.gov registry record · Phase 2
Follow-up Study of GSK Biologicals' Human Papilloma Virus (HPV) Vaccine to Prevent Cervical Infection in Young Adults
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 776
- Enrollment target
NCT00120848 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 776 participants.
The verdict
NCT00120848, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 776 participants
- Enrollment target
Study 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 infect the cervix (part of the uterus or womb). This infection often goes 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. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This is an observer blind follow up study of the study HPV-001, which evaluated the ability of the HPV vaccine to prevent HPV infection. The current study invites all of the 1113 subjects in the HPV-001 study that received all three doses of vaccine/placebo to be enrolled and followed-up for several additional years to see if the HPV vaccine prevents HPV-16 and HPV-18 infections and to evaluate the safety of the vaccine. Subjects will remain in the same study group as in the primary study. No vaccine or placebo will be administered in this study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
- BIOLOGICAL HPV 16/18 VLP AS04
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 776 participants |
| Start Date | 2003-11 |
| Est. Completion | 2007-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00120848
The ClinicalTrials.gov registry entry for NCT00120848 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 776 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HPV 16/18 VLP AS04 is the first listed.
NCT00120848 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00120848 about?
NCT00120848 is a clinical study titled "Follow-up Study of GSK Biologicals' Human Papilloma Virus (HPV) Vaccine to Prevent Cervical Infection in Young Adults". 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 infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it do...
What is the current status of trial NCT00120848?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 776 participants. The study started on 2003-11. Estimated completion is 2007-07.
What interventions are being tested in trial NCT00120848?
The interventions under investigation include: HPV 16/18 VLP AS04 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00120848?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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