At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Immunogenicity of a Shigella-Tetravalent Bioconjugate Vaccine: A Phase 1/2 Randomized Controlled and Age Descending Study Including Dose Finding in 9 Month Old Infants
In Brief
A Phase 1 clinical trial evaluating Shigella 4V, MenACWY, and 3 other interventions for Shigellosis. Completed, enrolled 597 participants across 2 sites.
Signals
Detailed Summary
In this study, the tetravalent bioconjugate candidate vaccine Shigella4V will be tested to obtain first-in-human data on its safety and immunogenicity in infants and to identify the preferred dose of Shigella4V in 9 month old infants.
Study Details
Timeline
Arms & Interventions
Infants receive 3 very low doses of the non-adjuvanted investigational product
Infants receive 3 very low doses of the adjuvanted investigational product
Infants receive 3 low doses of the non-adjuvanted investigational product
Infants receive 3 low doses of the adjuvanted investigational product
Infants receive 3 medium doses of the non-adjuvanted investigational product
Infants receive 3 medium doses of the adjuvanted investigational product
Children receive 3 medium doses of the non-adjuvanted investigational product
Children receive 3 medium doses of the adjuvanted investigational product
Adults receive 2 medium doses of the non-adjuvanted investigational product
Adults receive 2 medium doses of the adjuvanted investigational product
Infants receive 3 high doses of the non-adjuvanted investigational product
Infants receive 3 high doses of the adjuvanted investigational product
Chilldren receive 3 high doses of the non-adjuvanted investigational product
Chilldren receive 3 high doses of the adjuvanted investigational product
Adults receive 2 high doses of the non-adjuvanted investigational product
Adults receive 2 high doses of the adjuvanted investigational product
Adults receive one administration of MenACWY followed by one placebo administration
Children receive three administrations of Rabies
Infants receive two administrations of MenACWY followed by DTaP administration
Interventions
Non-adjuvanted and adjuvanted Shigella 4V administrated at 4 different doses: very low, low, medium and high.
Control vaccine administrated to adults and infants
Control vaccine administrated to children
Control vaccine administrated to infants
Control administrated to adults