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NCT00122681 · ClinicalTrials.gov registry record · Phase 3
Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 18,729
- Enrollment target
NCT00122681 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 18,729 participants.
The verdict
NCT00122681, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 18,729 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 study will evaluate the efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in young adolescents and women of 15/25 years of age at study start. Approximately 18.000 study subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
- BIOLOGICAL Cervarix™
- BIOLOGICAL Havrix™-based investigational formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18,729 participants |
| Start Date | 2004-05-06 |
| Est. Completion | 2009-11-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00122681
The ClinicalTrials.gov registry entry for NCT00122681 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 18,729 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 2 interventions - of which Cervarix™ is the first listed.
NCT00122681 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00122681 about?
NCT00122681 is a clinical study titled "Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18". 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 NCT00122681?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 18,729 participants. The study started on 2004-05-06. Estimated completion is 2009-11-26.
What interventions are being tested in trial NCT00122681?
The interventions under investigation include: Cervarix™ (BIOLOGICAL), Havrix™-based investigational formulation (BIOLOGICAL).
Who is sponsoring clinical trial NCT00122681?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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