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A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India
Sponsor: Takeda
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
Conditions
Interventions
TDV
TDV SC injection on Day 1 and Day 90 of the study
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