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NCT01926028 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Immunogenicity and Efficacy of NDV-3A Vaccine in Preventing Recurrent Vulvovaginal Candidiasis
A Phase 1 study, sponsored by NovaDigm Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 188
- Enrollment target
NCT01926028 is a Phase 1 study that has completed, run by NovaDigm Therapeutics. The registered enrollment target is 188 participants.
The verdict
NCT01926028, a Phase 1 study, has completed, sponsored by NovaDigm Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 188 participants
- Enrollment target
Study Summary
This is a multi-center, randomized, double-blind, placebo-controlled study intended to assess the safety, tolerability and humoral and cellular immune response over a 12-month period after receiving one dose of either the NDV-3A vaccine, NDV-3 vaccine, or placebo. In addition, the clinical efficacy of NDV-3A vaccine in lowering the recurrence rate of vulvovaginal candidiasis (VVC) in patients with recurrent VVC (RVVC) will be evaluated relative to placebo.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL NDV-3A
- BIOLOGICAL NDV-3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01926028
The ClinicalTrials.gov registry entry for NCT01926028 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 188 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NovaDigm Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01926028 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01926028 about?
NCT01926028 is a clinical study titled "Safety, Tolerability, Immunogenicity and Efficacy of NDV-3A Vaccine in Preventing Recurrent Vulvovaginal Candidiasis". This is a multi-center, randomized, double-blind, placebo-controlled study intended to assess the safety, tolerability and humoral and cellular immune response over a 12-month period after receiving one dose of either the NDV-3A vaccine, NDV-3 vaccine, or placebo. In addition, the clinical efficacy ...
What is the current status of trial NCT01926028?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 188 participants. The study started on 2013-07. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01926028?
The interventions under investigation include: Placebo (BIOLOGICAL), NDV-3A (BIOLOGICAL), NDV-3 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01926028?
This trial is sponsored by NovaDigm Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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