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Dose-Confirmation, Immunogenicity and Safety Study of the Clostridium Difficile Vaccine Candidate VLA84 in Healthy Adults Aged 50 Years and Older. Phase II Study
NCT02316470 · View on ClinicalTrials.gov ↗
Study Summary
Phase 2, randomized, observer-blind, placebo-controlled, multi-centric study including 4 parallel study groups. 500 Subjects (thereof, 250 aged 50 - 64 years and 250 aged 65 years and older) will be randomized in a (3:3:3:1) ratio to receive either VLA84 75 µg w/o (without) Alum, VLA84 200 µg w/o Alum, VLA84 200 µg w/ (with) Alum (150 subjects each), or placebo (50 subjects), as i.m. (intramuscular) vaccinations into alternating arms, on Days 0, 7 and 28
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL VLA84
Study Locations (10)
California
- eStudy Site, Chula Vista — Chula Vista
- eStudy Site, La Mesa — La Mesa
- eStudy Site, Oceanside — Oceanside
Other
- Berliner Zentrum für Reise- und Tropenmedizin — Berlin
- KFGN Klinische Forschung Hannover- Mitte GmbH — Hanover
- Klinik und Poliklinik für Innere Medizin der Universität Rostock — Rostock
Alabama
- Optimal Research LLC — Huntsville
Florida
- Optimal Research LLC — Melbourne
Illinois
- Optimal Research LLC — Peoria
Indiana
- Optimal Research LLC — Mishawaka
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2014-12 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02316470
The ClinicalTrials.gov registry entry for NCT02316470 describes a study currently listed as completed. It is categorized as Phase 2, 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 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Valneva Austria, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Clostridium Difficile appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT02316470 reports 10 study locations spanning 6 distinct geographic areas — top geographies include California, Other, Alabama. 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 NCT02316470 about?
NCT02316470 is a clinical study titled "Dose-Confirmation, Immunogenicity and Safety Study of the Clostridium Difficile Vaccine Candidate VLA84 in Healthy Adults Aged 50 Years and Older. Phase II Study". Phase 2, randomized, observer-blind, placebo-controlled, multi-centric study including 4 parallel study groups. 500 Subjects (thereof, 250 aged 50 - 64 years and 250 aged 65 years and older) will be randomized in a (3:3:3:1) ratio to receive either VLA84 75 µg w/o (without) Alum, VLA84 200 µg w/o A...
What is the current status of trial NCT02316470?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 500 participants. The study started on 2014-12. Estimated completion is 2015-10.
What conditions does trial NCT02316470 study?
This clinical trial studies the following conditions: Clostridium Difficile. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02316470?
The interventions under investigation include: Placebo (BIOLOGICAL), VLA84 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02316470?
This trial is sponsored by Valneva Austria, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02316470 being conducted?
This trial has 10 study locations across Alabama, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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