At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2a, Observer Blind, Randomized, Controlled, Single Center Study To Evaluate The Safety, Reactogenicity And Immunogenicity Of 2 Doses Of The GVGH 1790GAHB Vaccine Against Shigella Sonnei, Administered Intramuscularly In Adult Subjects From A Country Endemic For Shigellosis
In Brief
A Phase 2 clinical trial evaluating GVGH S. sonnei (1790GAHB) vaccine 25 μg, GVGH S. sonnei (1790GAHB) vaccine 100 μg, and 2 other interventions for Shigella Sonnei Infection. Completed, enrolled 74 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the safety and the immunogenicity of two different doses of the GVGH S. sonnei vaccine in healthy adults and represents the first step towards testing of the GMMA vaccine in the vaccine target population of children from developing countries where shigellosis is endemic.
Study Details
Timeline
Interventions
Two injections of the study vaccine were administered 28 days apart.
Two injections of the study vaccine were administered 28 days apart.
One injection of Menveo was administered in subjects in the Control Group.
One injection of Boostrix was administered in subjects in the Control Group.