At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
Shigella sonnei Strain WRSS1 Vaccine +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 1 Randomized, Double-Blinded, Placebo-controlled, Dose-Escalation Study to Assess the Safety, Tolerability and Immunogenicity of Live Attenuated, Oral Shigella WRSS1 Vaccine in Bangladeshi Toddlers (12 to 24 Months Old)
In Brief
A Phase 1 clinical trial evaluating Shigella sonnei Strain WRSS1 Vaccine and Placebo for Diarrhea. Completed, enrolled 16 participants across 1 site.
Detailed Summary
This is a research study of an experimental (investigational) live attenuated Shigella sonnei vaccine (WRSS1) to find a dose of the vaccine that is safe, tolerable, and develops an immune response. Shigella causes bloody and watery diarrhea, and infants and children living in developing countries experience the greatest consequences of this disease.
Study Details
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 2016
Enrollment StartFeb 2017
Primary CompletionJan 2018
TodayJul 2026
First PostedOct 14, 2016
Enrollment StartFeb 23, 2017
Primary CompletionJan 10, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.7 years ago
Interventions
Shigella sonnei Strain WRSS1 Vaccinebiological
Live attenuated, oral Shigella WRSS1 vaccine
Placebobiological
Sterile saline solution