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Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Participants

NCT02302066 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2020-02-24

Study results available
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Summary

The purpose of this study is to assess the humoral immune responses to three different dose schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) administered subcutaneously in healthy participants between 2 and \<18 years of age living in dengue endemic countries.

Conditions

  • Dengue Fever

Interventions

BIOLOGICAL

Takeda's Tetravalent Dengue Vaccine Candidate (TDV)

TDV subcutaneous injection

BIOLOGICAL

TDV Placebo

Placebo-matching vaccine

Sponsors & Collaborators

Principal Investigators

  • Program Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-05
Primary Completion
2019-02-18
Completion
2019-02-18

Countries

  • Dominican Republic
  • Panama
  • Philippines

Study Locations

More Related Trials

Entities

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 NCT02302066 on ClinicalTrials.gov