NCT01134263

Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia

Lot-to-Lot Consistency and Bridging Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 715 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Dengue Fever
• Dengue Hemorrhagic Fever

Interventions

Type	Name	Description
BIOLOGICAL	Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus	0.5 ml, Subcutaneous (SC)
BIOLOGICAL	Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus	0.5 ml, SC
BIOLOGICAL	Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus	0.5 ml, SC
BIOLOGICAL	Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus	0.5 ml, Subcutaneous (SC)
BIOLOGICAL	Placebo: NaCl 0.9%	0.5 ml, SC

Timeline

• Start date: 2010-10-05
• Primary completion: 2012-11-01
• Completion: 2013-02-01
• First posted: 2010-05-31
• Last updated: 2019-07-24
• Results posted: 2019-07-24

Locations

8 sites across 1 country: Australia