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NCT02316470 · ClinicalTrials.gov registry record · Phase 2
Dose-Confirmation, Immunogenicity and Safety Study of the Clostridium Difficile Vaccine Candidate VLA84 in Healthy Adults Aged 50 Years and Older. Phase II Study
A Phase 2 study of Clostridium Difficile, sponsored by Valneva Austria.
- Completed
- Registry status
- Phase 2
- Development phase
- 500
- Enrollment target
- 10
- Study locations
NCT02316470: Completed Phase 2 study of Clostridium Difficile, sponsored by Valneva Austria.
NCT02316470 is a Phase 2 study of Clostridium Difficile that has completed, run by Valneva Austria. The registered enrollment target is 500 participants, above the 378-participant average among 6 other Clostridium Difficile trials with a reported enrollment target (32% higher). The trial reports 10 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02316470, a Phase 2 study of Clostridium Difficile, has completed, sponsored by Valneva Austria.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 500 participants
- Enrollment target
- 10
- Study locations
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
Primary Outcome
Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against both Toxin A and Toxin B on Day 56;
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 |
What the finished NCT02316470 record still lists
NCT02316470 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 378-participant average among 6 other Clostridium Difficile trials with a reported enrollment target (32% higher).
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.
NCT02316470 lists 10 locations in 6 states (California, Other, Alabama).
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.
What interventions are being tested in trial NCT02316470?
The interventions under investigation include: Placebo (BIOLOGICAL), VLA84 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02316470?
This trial is sponsored by Valneva Austria, which has 11 total clinical trials registered on ClinicalTrials.gov.
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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