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CTRI Number  CTRI/2023/10/058630 [Registered on: 13/10/2023] Trial Registered Prospectively
Last Modified On: 16/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Safety and Immunogenicity of Dengue Tetravalent Vaccine in Subjects Aged 4 to 60 Years in India 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
DEN-302, Version 2.0, dated 15 Jun 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Shweta Pradhan 
Designation  Head Clinical Operations 
Affiliation  IQVIA RDS (India) Private Limited 
Address  IQVIA RDS (India) Private Limited Omega Embassy Tech Square, Marathahalli - Sarjapura
Outer Ring Road, Kadubeesanahalli,
Bangalore
KARNATAKA
560103
India 
Phone  9513774664  
Fax    
Email  shweta.pradhan@iqvia.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Shweta Pradhan 
Designation  Head Clinical Operations 
Affiliation  IQVIA RDS (India) Private Limited 
Address  IQVIA RDS (India) Private Limited Omega Embassy Tech Square, Marathahalli - Sarjapura
Outer Ring Road, Kadubeesanahalli,
Bangalore
KARNATAKA
560103
India 
Phone  9513774664  
Fax    
Email  shweta.pradhan@iqvia.com  
 
Source of Monetary or Material Support  
Takeda Vaccines, Inc. 40 Landsdowne Street, Cambridge, MA 02139, USA 
 
Primary Sponsor  
Name  Takeda Vaccines, Inc. 
Address  40 Landsdowne Street, Cambridge, MA 02139, USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
IQVIA RDSIndia Pvt Ltd  Omega Embassy TechSquare, Marathahalli-Sarjapur Outer Ring Road, Kadubeesanahalli, Bangalore – 560103, Karnataka 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mohan ME  BGS Global Institute of Medical Sciences  No.67, BGS Health and Education City, Uttarahalli Road, Kengeri,
Bangalore
KARNATAKA 		 9900126444

drmohanbgsresearch@gmail.com 
Dr Jaishree Vasudevan   Chettinad Academy of Research and Education  Chettinad Health City, SH, 49 A, Dist. Kelambakkam
Kancheepuram
TAMIL NADU 		 9444362134

drjaishree.research@gmail.com 
Dr Jyotiranjan Sahoo  Institute of Medical Sciences and SUM Hospital  Room no- 1, Community Medicine Department, 2nd Floor, K8 Kalinga Nagar, Bhubaneswar, Khordha-751003
Khordha
ORISSA 		 8895714278

jyotiranjansahoo@soa.ac.in 
Dr SK Nasim  IPGME&R and SSKM Hospital  Department of General Medicine, Ronald Ross Building 4th Floor 244 AJC Bose Road Kolkata-700020
Kolkata
WEST BENGAL 		 9681116876

sknasim09@gmail.com 
Dr Ashish Bavdekar   KEM Hospital Research Centre  Room No-315, Pediatric Research Unit, 3rd floor Research Center, Sardar Moodliar Road, Rasta Peth, Pune - 411011
Pune
MAHARASHTRA 		 9822056174

a.bavdekar@kemhrcpune.org 
Dr Konatham Rambabu  King George Hospital  Clinical Research Room, Department of General Medicine, First Floor, Rajendra Prasad Ward, King George Hospital, Maharanipeta, Visakhapatnam-530002
Visakhapatnam
ANDHRA PRADESH 		 9177747328

drkrambaburesearch@gmail.com 
Dr Himanshu Dandu  King George’s Medical University  Room no- 505, Department of Medicine, Fifth Floor, Kalam center, KGMU King George’s Medical University Chowk, Lucknow-226003
Lucknow
UTTAR PRADESH 		 9839266822

dr.himanshu.reddy@gmail.com 
Dr Devendra Mishra  Maulana Azad Medical College & Associated Lok Nayak Hospital  Department of Pediatrics, Near Ward No-19, Bahadur Shah Zafar Marg, New Delhi-110002
New Delhi
DELHI 		 9968604316
01123236031
drdmishra@gmail.com 
Dr Jerin James  SRM Medical College Hospital & Research Centre  3rd Floor, SRM Centre for Clinical Trials and Research,SRM Nagar, Potheri, Kattankulathur, Chengalpattu - 603203,
Kancheepuram
TAMIL NADU 		 8870077633

jerinj@srmist.edu.in 
Dr Kailash Rathi  Suyog Hospital  2nd Floor, B-Wing, Krushi Utpanna Bazar Samiti Sankul, Dindori Road, Panchavati, Nashik - 422003
Nashik
MAHARASHTRA 		 9422254748

drkrathi@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Chettinad Academy of Research and Education  Approved 
IEC IMS and SUM Hospital  Approved 
Institutional Ethics Committee Maulana Azad Medical College  Approved 
Institutional Ethics Committee Research Cell, KGMU  Approved 
Institutional Ethics Committee, BGS Global Institute of Medical Sciences  Approved 
Institutional Ethics Committee, King George Hospital  Approved 
IPGME&R Research Oversight Committee  Approved 
KEM Hospital Research Centre Ethics Committee  Approved 
SRM Medical College Hospital & Research Centre Ethics Committee  Approved 
Suyog Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Prevention of dengue fever 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lyophilised Tetravalent Dengue Vaccine and Diluent  Lyophilised Tetravalent Dengue Vaccine (TDV) for 0.5mL subcutaneous injection and Diluent (37 mM NaCl solution) 1mL Route: SC route Dose: 0.5mL subcutaneous injection. Duration: Screening Procedures (Day -28 [M -1]); Pre-Vaccination Procedures (Day 1 [M0] and Day 90 [M3]); Vaccination Procedures (Day 1 [M0] and Day 90 [M3]); Post Vaccination Procedures (Day 1 [M0] and Day 90 [M3]); 9.3.5 Site Visits after Vaccination (Day 30 [M1] and Day 120 [M4]) and Final (End of Trial) Visit (Day 270 [M9]) 
Comparator Agent  Placebo for 0.5mL subcutaneous injection Normal saline, NaCl 0.9% Solution  Route: SC route Dose: 0.5mL subcutaneous injection. Duration: Screening Procedures (Day -28 [M -1]); Pre-Vaccination Procedures (Day 1 [M0] and Day 90 [M3]); Vaccination Procedures (Day 1 [M0] and Day 90 [M3]); Post Vaccination Procedures (Day 1 [M0] and Day 90 [M3]); 9.3.5 Site Visits after Vaccination (Day 30 [M1] and Day 120 [M4]) and Final (End of Trial) Visit (Day 270 [M9]) 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subjects aged ≥4 to ≤60 years at the time of random assignment.
2. Male or female.
3. Subjects in good health at the time of entry into the trial.
4. Subjects and/or the subjects legally acceptable representative (LAR) who have signed and dated a written, informed consent/pediatric assent form, and any required privacy authorization prior to the initiation of any trial procedures.
5. Subjects who can comply with trial procedures and are available for the duration of follow-up
 
 
ExclusionCriteria 
Details  1. Subjects with any illness, or history of any illness that in the opinion of the investigator, might interfere with the results of the trial or pose an additional risk to the subject due to participation in the trial
2. Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject’s ability to participate in the trial.
3. BMI ≥35 kg/m2
4. Intent to participate in another clinical trial at any time during the conduct of this trial
5. Subject plans to receive any of the following (consider whether applicable as an exclusion criterion or as a criterion for delay of Visit 1):
a) A licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to TDV or placebo administration.
b) A coronavirus vaccine within 14 days prior to TDV or placebo administration.
c) A vaccine authorized for emergency use within 28 days of TDV or placebo administration.
6. Known substance or alcohol abuse within the past 2 years.
7. Pregnant subjects (ie, a positive or indeterminate pregnancy test) or breastfeeding.
8. Females of childbearing potential who are sexually active, and who:
1. have not used any of the acceptable contraceptive methods for at least 2 months prior to Day 1.
2. refuse to use an acceptable contraceptive method up to 6 weeks after the last dose of TDV or placebo.
9. Involved in the trial conduct or their first-degree relatives.
10. Subjects identified as an employee of the investigator or trial center, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial center.
11. Receipt of previous vaccination against dengue virus.
12. Previous participation in any clinical trial of a dengue candidate vaccine, except if it is known that the subject received placebo while participating in those trials.
Exclusion Criteria at Vaccination
1. Febrile illness (body temperature ≥38°C [≥100.4°F]) or moderate or severe acute illness, or infection, at the time of random assignment
2. Medicated with antipyretic and/or analgesic medication(s) within 24 hours prior to TDV or placebo administration
3. Any new findings of illness in the interim period since screening Visit 1  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Safety
- To assess the safety profile of TDV administered as 2 doses given 3 months apart in healthy adults, adolescents, & children.
Immunogenicity
- To evaluate the immunogenicity of TDV administered as 2 doses given 3 months apart in healthy adults, adolescents, and children at 1 month post second dose 		 Safety
3 months apart in healthy adults, adolescents, & children
Immunogenicity
3 months apart in healthy adults, adolescents, & children at 1 month post second dose 
 
Secondary Outcome  
Outcome  TimePoints 
Immunogenicity
- To describe immunogenicity of TDV at baseline & 6 months post second TDV dose when administered as 2 doses given 3 months apart.
- To describe seropositivity (% of subjects with reciprocal neutralizing titer ≥10) at baseline, 1 month post TDV second dose & 6 months post second TDV dose. 		 3 months & 6 months post second TDV dose 
 
Target Sample Size   Total Sample Size="480"
Sample Size from India="480" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   12/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a phase 3, randomized, multi-site, double-blind, placebo-controlled trial in 480 healthy subjects aged ≥4 to ≤60 years living in India.

• Cohort 1: 240 subjects ≥18 to ≤60 years of age will be enrolled and randomly assigned (3:1) to receive either TDV (N=180) or placebo (N=60) at Day 1 (Month [M] 0) and Day 90 (M3).

• Cohort 2: 240 subjects ≥4 to <18 years of age will be enrolled and randomly assigned (3:1) to receive either TDV (N=180) or placebo (N=60) at Day 1 (M0) and Day 90 (M3).

Cohorts 1 and 2 will be enrolled in parallel.

Adolescents who attain the legal age of consent during or after Visit 1 (Day -28 [M -1]) will be asked to return to the investigational site to attest to the appropriate written informed consent. This may require an additional site visit. 
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