CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 500 enrolled
Drug / intervention
VLA84 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02316470
NCT02316470Phase 2Completed
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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. Randomized, Controlled, Observer Blind Phase II Study

Valneva Austria GmbH·interventional·Posted Dec 15, 2014·Updated Jun 8, 2017

In Brief

A Phase 2 clinical trial evaluating VLA84 and Placebo for Clostridium Difficile. Completed, enrolled 500 participants across 10 sites in 2 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridium Difficile
CountriesGermany, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 15, 2014
Enrollment StartDec 1, 2014
Primary CompletionMay 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.5 years ago

Interventions

VLA84biological

a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B

Placebobiological

phosphate buffered saline (PBS) solution