At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 110 enrolled
Drug / intervention
Shigella4V2 +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.
Safety and Immunogenicity of a Second Generation Shigella Bioconjugate Vaccine: a Phase II Randomized, Controlled, and Blinded Study in 9-month-old Infants
In Brief
A Phase 2 clinical trial evaluating Shigella4V2 and MenACWY for Shigellosis. Completed, enrolled 110 participants across 1 site.
Detailed Summary
In this study, the second-generation tetravalent bioconjugate candidate vaccine Shigella4V2 will be tested to confirm data on its safety and immunogenicity in infants and to identify the best dose of Shigella4V2 in 9-month-old infants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShigellosis
CountriesKenya
CollaboratorsKenya Medical Research Institute
Timeline
Phase 2CompletedFinished
20252026
First PostedJul 2024
Enrollment StartApr 2025
Primary CompletionAug 2025
Study CompletionJan 2026
TodayJul 2026
First PostedJul 26, 2024
Enrollment StartApr 7, 2025
Primary CompletionAug 27, 2025
Study CompletionJan 22, 2026
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 1.9 years ago
Interventions
Shigella4V2biological
Adjuvanted Shigella4V2 administrated at 2 different doses: low and high.
MenACWYbiological
Control vaccine