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NCT00359619 · ClinicalTrials.gov registry record · Phase 2
Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 383
- Enrollment target
NCT00359619: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00359619 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 383 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (188% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00359619, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 383 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).
Interventions
- BIOLOGICAL CervarixTM
- BIOLOGICAL HPV investigational vaccine GSK568893A, different formulations
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 383 participants |
| Start Date | 2006-09-12 |
| Est. Completion | 2007-01-30 |
| Phase | Phase 2 |
What the finished NCT00359619 record still lists
NCT00359619 is an interventional study that assigns participants to a tested intervention. The registered 383 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 (188% higher).
The record links to 0 conditions, and to 2 interventions - of which CervarixTM is the first listed.
NCT00359619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00359619 about?
NCT00359619 is a clinical study titled "Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine". 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 infec...
What is the current status of trial NCT00359619?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 383 participants. The study started on 2006-09-12. Estimated completion is 2007-01-30.
What interventions are being tested in trial NCT00359619?
The interventions under investigation include: CervarixTM (BIOLOGICAL), HPV investigational vaccine GSK568893A, different formulations (BIOLOGICAL).
Who is sponsoring clinical trial NCT00359619?
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 NCT00359619's enrollment target sits among peer trials
383 111th of 2000 higher than 1,890 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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