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Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia

2014-07-24 14:01:10 | BioPortfolio

Summary

The purpose of this study is 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.

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 Phase II and pooled Phase III lots of CYD Dengue vaccine induce an equivalent immune response in terms of post-Dose 3 GMTs against the four parental serotypes.

- To describe the safety (in terms of solicited injection site and systemic reactions and unsolicited adverse events) of the CYD Dengue vaccine in all subjects after each dose.

Description

All subjects will receive 3 doses of their assigned vaccine or placebo and will provide blood samples at defined timepoints for flavivirus status and immunogenicity assessment. Reactogenicity data will be collected in all subjects after each dose and throughout the study.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Conditions

Dengue Fever

Intervention

Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus, Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus, Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus, Live, attenuated, recombinant dengue serotypes 1, 2, 3

Location

Adelaide
Australia
SA 5000

Status

Not yet recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:01:10-0400

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