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NCT01489527 · ClinicalTrials.gov registry record · NA
Preparedness Study - HPV Vaccine
A NA study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 406
- Enrollment target
NCT01489527 is a NA study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 406 participants.
The verdict
NCT01489527, a NA study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 406 participants
- Enrollment target
Study Summary
Moffitt Cancer Center is the Coordinating Center for this study. The purpose of this study is to develop and test the infrastructure to conduct a future Phase III vaccine efficacy trial to assess trial feasibility, and to assess human papillomavirus (HPV) genotype distribution, data needed to design a Phase III trial. The investigators propose to conduct a Preparedness study among women ages 16-24 years of age residing in a region of South Africa with a high human immunodeficiency (HIV) incidence and prevalence. The specific aims of this study are to: 1. Identify, recruit, enroll, and randomize a cohort of HIV negative women (200 per arm, 400 total) ages 16-24 years to an HPV vaccine against 4 types (HPV 6, 11, 16, 18 \[Gardasil\]) or placebo vaccine. 2. Determine the cervical HPV prevalence and type distribution at enrollment, and cervical lesion prevalence among young females ages 16-24 years at high risk for HIV infection. 3. Assess the rate of compliance through the 3-dose vaccination series
Interventions
- OTHER Placebo
- BIOLOGICAL Gardasil Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01489527
The ClinicalTrials.gov registry entry for NCT01489527 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 406 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01489527 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01489527 about?
NCT01489527 is a clinical study titled "Preparedness Study - HPV Vaccine". Moffitt Cancer Center is the Coordinating Center for this study. The purpose of this study is to develop and test the infrastructure to conduct a future Phase III vaccine efficacy trial to assess trial feasibility, and to assess human papillomavirus (HPV) genotype distribution, data needed to desig...
What is the current status of trial NCT01489527?
This trial is currently completed. It is a NA study. The enrollment target is 406 participants. The study started on 2012-09. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01489527?
The interventions under investigation include: Placebo (OTHER), Gardasil Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01489527?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
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