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NCT01447407 · ClinicalTrials.gov registry record · Phase 1
Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine
A Phase 1 study of Candidiasis and Staphylococcal Infections, sponsored by NovaDigm Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 164
- Enrollment target
- 1
- Study location
NCT01447407 is a Phase 1 study of Candidiasis and Staphylococcal Infections that has completed, run by NovaDigm Therapeutics. The registered enrollment target is 164 participants, below the 307-participant average among 7 other Candidiasis trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01447407, a Phase 1 study of Candidiasis and Staphylococcal Infections, has completed, sponsored by NovaDigm Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 164 participants
- Enrollment target
- 1
- Study location
Study Summary
This partially-blind, placebo controlled study is a Phase 1b study using an investigational vaccine, NDV-3, directed against Staphylococcus aureus and Candida sp. This study will compare NDV-3 administered with or without alum delivered intramuscularly (IM) at one dose level. It will also evaluate a lower dose of NDV-3 without alum delivered intradermally (ID) compared to placebo delivered ID.
Conditions Studied
Interventions
- BIOLOGICAL NDV-3 vaccine with alum IM
- BIOLOGICAL NDV-3 vaccine without alum IM
- BIOLOGICAL Placebo with alum IM
- BIOLOGICAL NDV-3 vaccine without alum ID
Study Locations (1)
North Dakota
- Cetero Research Clinical Site - Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01447407
The ClinicalTrials.gov registry entry for NCT01447407 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 307-participant average among 7 other Candidiasis trials with a reported enrollment target (47% lower). The listed sponsor is NovaDigm Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Candidiasis appearing as the primary indexed condition, and to 4 interventions - of which NDV-3 vaccine with alum IM is the first listed.
NCT01447407 reports 1 study location spanning 1 distinct geographic area - top geographies include North Dakota.
Frequently Asked Questions
What is clinical trial NCT01447407 about?
NCT01447407 is a clinical study titled "Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine". This partially-blind, placebo controlled study is a Phase 1b study using an investigational vaccine, NDV-3, directed against Staphylococcus aureus and Candida sp. This study will compare NDV-3 administered with or without alum delivered intramuscularly (IM) at one dose level. It will also evaluate a...
What is the current status of trial NCT01447407?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 164 participants. The study started on 2011-09. Estimated completion is 2012-12.
What conditions does trial NCT01447407 study?
This clinical trial studies the following conditions: Candidiasis, Staphylococcal Infections, Yeast Infections.
What interventions are being tested in trial NCT01447407?
The interventions under investigation include: NDV-3 vaccine with alum IM (BIOLOGICAL), NDV-3 vaccine without alum IM (BIOLOGICAL), Placebo with alum IM (BIOLOGICAL), NDV-3 vaccine without alum ID (BIOLOGICAL).
Who is sponsoring clinical trial NCT01447407?
This trial is sponsored by NovaDigm Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01447407 being conducted?
This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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