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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: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00120848 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 776 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (483% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00120848 record still lists
NCT00120848 is an interventional study that assigns participants to a tested intervention. The registered 776 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (483% higher).
The record links to 0 conditions, and to 1 intervention - of which HPV 16/18 VLP AS04 is the first listed.
NCT00120848 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00120848's enrollment target sits among peer trials
776 42nd of 2000 higher than 1,959 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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