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Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia

NCT01134263 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 715

Last updated 2019-07-24

Study results available
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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.

Conditions

  • Dengue Fever
  • Dengue Hemorrhagic Fever

Interventions

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

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-05
Primary Completion
2012-11-30
Completion
2013-02-28

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01134263 on ClinicalTrials.gov