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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: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00122681 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 18,729 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (2329% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: 1. DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). 2. Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostat
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 |
What the finished NCT00122681 record still lists
NCT00122681 is an interventional study that assigns participants to a tested intervention. Its 18,729 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (2329% higher).
The record links to 0 conditions, and to 2 interventions - of which Cervarix™ is the first listed.
NCT00122681 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00122681's enrollment target sits among peer trials
18,729 11th of 2000 higher than 1,990 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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