At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3,146 enrolled
Drug / intervention
PXVX0200 Lot A +3 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.
Phase 3 Randomized, Double-blind, Placebo-Controlled 3-Lot Study in Healthy Volunteers to Assess Immunogenicity, & Acceptability of a Single-dose of Live Oral Cholera Vaccine, Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR
In Brief
A Phase 3 clinical trial evaluating PXVX0200 Lot A, PXVX0200 Lot B, and 2 other interventions for Cholera. Completed, enrolled 3,146 participants across 25 sites in 2 countries.
Detailed Summary
The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCholera
CountriesAustralia, United States
CollaboratorsEmergent BioSolutions
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartMay 2014
Primary CompletionFeb 2015
Study CompletionJun 2015
TodayJul 2026
First PostedMar 24, 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
PXVX0200 Lot Abiological
Lot P700-1CA03
PXVX0200 Lot Bbiological
Lot P700-3CA03
PXVX0200 Lot Cbiological
Lot P700-6BA03
Placebobiological
Placebo