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NCT00007501 · ClinicalTrials.gov registry record · Phase 3
Shingles Prevention Study
A Phase 3 study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 3
- Development phase
- 38,456
- Enrollment target
NCT00007501 is a Phase 3 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 38,456 participants.
The verdict
NCT00007501, a Phase 3 study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 38,456 participants
- Enrollment target
Study Summary
The incidence and severity of HZ (or shingles), as well as the frequency and severity of its complications, increases markedly with increasing age. More than half of all cases occur in persons over the age of 60. Even without complications, HZ can interfere with an elderly patient's ability to perform essential activities of daily living, resulting in a loss of independence that is emotionally devastating and frequently irreversible. The most common complication of HZ in elderly persons is postherpetic neuralgia (PHN), which frequently results in disordered sleep, chronic fatigue, anxiety and severe depression. Antiviral therapy has a modest impact on the acute phase of HZ. However, it does not appear to prevent the development of PHN. This study is a 5.5 year randomized, double-blind, placebo-controlled, efficacy trial to determine whether vaccination with live-attenuated Oka/Merck varicella-zoster decreases the incidence and/or severity of herpes zoster (HZ) and its complications in adults 60 years of age and older.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Varicella-zoster vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38,456 participants |
| Start Date | 1998-11 |
| Est. Completion | 2011-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00007501
The ClinicalTrials.gov registry entry for NCT00007501 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 38,456 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00007501 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00007501 about?
NCT00007501 is a clinical study titled "Shingles Prevention Study". The incidence and severity of HZ (or shingles), as well as the frequency and severity of its complications, increases markedly with increasing age. More than half of all cases occur in persons over the age of 60. Even without complications, HZ can interfere with an elderly patient's ability to perfo...
What is the current status of trial NCT00007501?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 38,456 participants. The study started on 1998-11. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00007501?
The interventions under investigation include: Placebo (BIOLOGICAL), Varicella-zoster vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00007501?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
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