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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: Completed NA study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
HPV type distribution and prevalence of each HPV type at enrollment.
Interventions
- OTHER Placebo
- BIOLOGICAL Gardasil Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-12 |
| Phase | NA |
What the finished NCT01489527 record still lists
NCT01489527 is an interventional study that assigns participants to a tested intervention. The registered 406 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01489527 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01489527's enrollment target sits among peer trials
406 243rd of 2000 higher than 1,758 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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