Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01134263
Study type	Interventional
Source	Sanofi
Contact
Status	Completed
Phase	Phase 3
Start date	October 5, 2010
Completion date	February 2013

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