At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Immunogenicity of a Klebsiella Pneumoniae Tetravalent Bioconjugate Vaccine (Kleb4V) Administered to Healthy Adults: A FTIH Phase I/II Randomized and Controlled Study
In Brief
A Phase 2 clinical trial evaluating Kleb4V target dose, Kleb4V target dose + AS03, and 3 other interventions for Klebsiella Pneumoniae Infection. Completed, enrolled 166 participants across 2 sites.
Detailed Summary
In this study, the tetravalent bioconjugate candidate vaccine Kleb4V will be tested to obtain first-time-in-human (FTIH) data on its safety and immunogenicity in healthy adults.
Study Details
Timeline
Interventions
Two doses of the non-adjuvanted Kleb4V target dose will be administered intramuscularly 2 months apart
Two doses of the adjuvanted Kleb4V target dose will be administered intramuscularly 2 months apart
Two doses of the non-adjuvanted Kleb4V low dose will be administered intramuscularly 2 months apart
Two doses of the adjuvanted Kleb4V low dose will be administered intramuscularly 2 months apart
Two doses of the Placebo will be administered intramuscularly 2 months apart