At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 398 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 III Randomized, Double-blind, Placebo-controlled Study in Older Adults to Assess Immunogenicity and Clinical Acceptability of a Single-dose of the Live Oral Cholera Vaccine Candidate PXVX0200 O1 Serotype Inaba Strain CVD 103-HgR
In Brief
A Phase 3 clinical trial evaluating PXVX0200 and Placebo for Cholera. Completed, enrolled 398 participants across 16 sites.
Detailed Summary
Demonstrate that the vaccine offers protection based on antibody levels in older adults and is similar to antibody levels in adults aged 18-45 following vaccination with PXVX0200.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCholera
CountriesUnited States
CollaboratorsEmergent BioSolutions
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartMay 2014
Primary CompletionFeb 2015
Study CompletionJun 2015
TodayJul 2026
First PostedApr 1, 2014
Enrollment StartMay 1, 2014
Primary CompletionFeb 1, 2015
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.3 years ago
Interventions
PXVX0200biological
Placebobiological