At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 197 enrolled
Drug / intervention
PXVX0200 +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.
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Efficacy Trial of a Single Dose Live Oral Cholera Vaccine, PXVX0200 CVD 103-HgR, in Preventing Cholera Following Challenge With Vibrio Cholerae 10 Days or 3 Months After Vaccination
In Brief
A Phase 3 clinical trial evaluating PXVX0200 and placebo for Cholera. Completed, enrolled 197 participants across 3 sites.
Detailed Summary
The purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCholera
CountriesUnited States
CollaboratorsEmergent BioSolutions
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 2013
Enrollment StartSep 2013
Primary CompletionNov 2014
TodayJul 2026
First PostedJul 11, 2013
Enrollment StartSep 1, 2013
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.0 years ago
Interventions
PXVX0200biological
Single dose; liquid suspension after reconstitution with buffer; 5x10\^8
placebobiological