At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Lot-to-Lot Consistency and Bridging Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia
In Brief
A Phase 3 clinical trial evaluating Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus and Placebo: NaCl 0.9% for Dengue Fever and Dengue Hemorrhagic Fever. Completed, enrolled 715 participants across 8 sites.
Detailed Summary
The purpose of this study was to demonstrate that different CYD dengue vaccine lots manufactured using the same method and in the same location but at different times produce an equivalent immunological response after 3 doses. Primary Objective * To demonstrate that three different Phase III lots of CYD dengue vaccine induce an equivalent immune response in terms of post-Dose 3 geometric mean titers (GMTs) against the four parental serotypes. Secondary Objectives: * To demonstrate that data from one Phase II lot and pooled data from Phase III lots of CYD dengue vaccine show an equivalent immune response in terms of post-Dose 3 GMTs against the four parental serotypes. * To describe the safety of the CYD dengue vaccine in all participants after each dose.
Study Details
Timeline
Interventions
0.5 ml, Subcutaneous (SC)
0.5 ml, SC
0.5 ml, SC
0.5 ml, Subcutaneous (SC)
0.5 ml, SC