Dengue Fever Clinical Trial
Official title:
Lot-to-Lot Consistency and Bridging Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia
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.
All participants received 3 doses of their assigned vaccine or placebo and provided blood samples at defined timepoints for flavivirus status and immunogenicity assessment. Safety data were collected in all participants after each dose and throughout the study. ;
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