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Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine
NCT01447407 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NovaDigm Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01447407 reports 1 study location spanning 1 distinct geographic area — top geographies include North Dakota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01447407?
This trial is sponsored by NovaDigm Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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