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COMPLETED
NCT06060067
PHASE3

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

Sponsor: Takeda

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Safety and Immunogenicity of a Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Administered Subcutaneously to Healthy Subjects Aged 4 to 60 Years in India

Key Details

Gender

All

Age Range

4 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

480

Start Date

2024-03-29

Completion Date

2025-05-05

Last Updated

2026-05-29

Healthy Volunteers

Yes

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

Locations (10)

BGS Global Institute of Medical Sciences (BGS-GIMS) #67, BGS Health & Education City, Uttarahalli Main Road, Kengeri

Bangalore, Karnataka, India

Chettinad Academy of Research and Education, Chettinad Health City, SH,49A, Dist. Kelambakkam

Pudupākkam, Tamil Nadu, India

Preventive and Therapeutic Clinical Trial Unit (PTCTU), Dept. of Community Medicine, Institute of Medical Science and SUM Hospital, K-8, Kalinga Nagar

Bhubaneswar, India

SRM Medical College Hospital & Research Centre, SRM Nagar, Potheri

Kattankulathur, India

IPGME&R and SSKM Hospital, 244 AJC Bose Road

Kolkata, India

King George's Medical University, Department of Medicine, Chowk

Lucknow, India

Suyog Hospital, 2nd Floor, B-Wing, Krushi Utpanna Bazar, Samiti Sankul, Dindori Rd, Panchavati

Nashik, India

Maulana Azad Medical College & Associated Lok Nayak, Govind Ballabh Pant Hospitals and Guru Nanak Eye Center

New Delhi, India

KEM Hospital Research Centre, Sandar Moodliar Road, Rasta Peth

Pune, India

King George Hospital

Visakhapatnam, India