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Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV)

NCT02193087 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1002

Last updated 2019-07-18

Study results available
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Summary

The purpose of this study is to evaluate the equivalence of the lyophilized formulation of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) compared with the liquid formulation of TDV.

Conditions

  • Dengue Fever

Interventions

DRUG

TDV Liquid Formulation 1

TDV Liquid Formulation 1 for subcutaneous injection

DRUG

TDV Liquid Formulation 2

TDV Liquid Formulation 2 for subcutaneous injection

DRUG

TDV IDT Lyophilized

TDV Lyophilized Formulation for subcutaneous injection

DRUG

Placebo

TDV liquid formulation placebo-matching solution for subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-08-06
Primary Completion
2015-05-19
Completion
2015-05-19

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT02193087 on ClinicalTrials.gov