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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 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 383 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00359619
The ClinicalTrials.gov registry entry for NCT00359619 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 383 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 CervarixTM is the first listed.
NCT00359619 reports 0 study locations.
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.
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