MedTrace Logo

A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India

NCT06060067 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2025-11-26

No results posted yet for this study

Summary

The main aims of the study are to learn about side effects and a participant's immune response to Takeda's Dengue Vaccine when given twice within 3 months.

Participants will receive 2 doses of their randomized treatment (vaccine or placebo). Children, teenagers and adults will receive one dose of either the vaccine or placebo on Day 1 and the second dose of either the vaccine or placebo 3 months later. Up to 4 blood samples will be taken throughout the study.

During the study, participants will visit their study clinic 6 times.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

TDV

TDV SC injection on Day 1 and Day 90 of the study

BIOLOGICAL

Placebo

Normal Saline (0.9% NaCl) SC injection on Day 1 and Day 90 of the study

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-03-29
Primary Completion
2025-05-05
Completion
2025-05-05

Countries

  • India

Study Locations

More Related Trials

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 NCT06060067 on ClinicalTrials.gov