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Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children

NCT02747927 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20099

Last updated 2025-11-19

Study results available
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Summary

The main purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 4 to 16 year old participants.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Placebo

TDV placebo-matching SC injection.

BIOLOGICAL

Tetravalent Dengue Vaccine (TDV)

TDV SC injection.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-26
Primary Completion
2018-07-11
Completion
2024-06-28

Countries

  • Brazil
  • Colombia
  • Dominican Republic
  • Nicaragua
  • Panama
  • Philippines
  • Sri Lanka
  • Thailand

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 NCT02747927 on ClinicalTrials.gov