FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/01/061776 [Registered on: 23/01/2024] Trial Registered Prospectively
Last Modified On: 16/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study for assessment of safety and immunogenicity of Dengusiil vaccine in Indian adults and children. 
Scientific Title of Study   A Seamless Phase 1/2, double blind, randomized, placebo-controlled study to evaluate the safety and immunogenicity of Dengusiil in Indian adults and children of more than 2 years of age 
Trial Acronym  Dengusiil-02 
Secondary IDs if Any  
Secondary ID  Identifier 
Dengusiil-02 Version No. 2.0 Dated 24 May 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  
Name  Dr Prasad Kulkarni MD 
Designation  Executive Director 
Affiliation  Serum Institute of India Private Limited, Pune 
Address  Serum Institute of India Private Limited (SIIPL), 212/2, Off Soli Poonawalla Road, Hadapsar, Pune - 411028, Maharashtra, India

Pune
MAHARASHTRA
411028
India 
Phone  912071946836  
Fax    
Email  drpsk@seruminstitute.com  
 
Details of Contact Person
Public Query  
Name  Dr Prasad Kulkarni MD 
Designation  Executive Director 
Affiliation  Serum Institute of India Private Limited, Pune 
Address  Serum Institute of India Private Limited (SIIPL), 212/2, Off Soli Poonawalla Road, Hadapsar, Pune - 411028, Maharashtra, India

Pune
MAHARASHTRA
411028
India 
Phone  912071946836  
Fax    
Email  drpsk@seruminstitute.com  
 
Source of Monetary or Material Support  
Serum Institute of India Pvt. Ltd. 
 
Primary Sponsor  
Name  Serum Institute of India Private Limited (SIIPL) 
Address  Serum Institute of India Private Limited (SIIPL), 212/2, Off Soli Poonawalla Road, Hadapsar, Pune - 411028, Maharashtra, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neeta Hanumante  Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune  Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune, Maharashtra – 411043, India
Pune
MAHARASHTRA 		 00912040555555

neeta.hanumante@bharatividyapeeth.edu 
Dr Sunil Kohli  Hamdard Institute of Medical Sciences and Research, New Delhi  Clinical Research Centre – HIMSR with CHRD-SAS Block B, Basement, Hamdard Institute of Medical Sciences and Research (HIMSR), with Centre for Health Research and Development - Society for Applied Studies (CHRD-SAS), Guru Ravidas Marg, Hamdard Nagar, New Delhi-110062, India
New Delhi
DELHI 		 00911164788217

sunil.kohli@gmail.com 
Dr Sonali Kar  Kalinga Institute of Medical Sciences, Bhubaneswar  Clinical Epidemiological Unit, Department of Community Medicine, OBG and Paediatrics Block,Kushabhadra Campus , KIIT Campus, 5, KIIT Road, Patia, Bhubaneswar, Odisha 751024, India
Khordha
ORISSA 		 00916742725228

sonsam72@yahoo.co.uk 
Dr Ashish Bavdekar  KEM Hospital Research Centre, Pune  Room no. 315, Pediatric research unit, TDH Building, 3rd floor, 489, Rasta Peth, Sardar Moodliar Road, Pune, Maharashtra 411011, India
Pune
MAHARASHTRA 		 00912066037342

ashish.bavdekar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee Bharati Vidyapeeth Deemed University, Pune  Approved 
Institutional Ethics Committee Kalinga Institute of Medical Sciences (KIMS) KIIT Deemed-to-be University, Bhubaneshwar  Approved 
KEM Hospital Research Centre Ethics Committee, Pune  Approved 
The Institutional Ethics Committee, Hamdard Institute of Medical Sciences and Research and Associated HAH Centenary Hospital (IEC-HIMSR)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dengue 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dengusiil vaccine  Dengusiil is provided as a single dose lyophilized powder containing live attenuated DENV serotypes 1 to 4 to be reconstituted with 0.5 mL sterile water for injection (sWFI). 
Comparator Agent  Placebo  Placebo is provided as a single dose lyophilized powder containing all the components of the vaccine except Dengue virus serotypes 1 to 4 to be reconstituted with 0.5 mL sterile water for injection (sWFI). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Healthy adults aged 18-60 years of age - adult cohort
2. Healthy children aged more than 2 to less than 18 years of age for pediatric cohort
3. Participants who give written informed consent and or assent for children of more than 12 to less than 18 years of age 
 
ExclusionCriteria 
Details  1. Previous dengue vaccination.
2. Presence of acute infection in the preceding 14 days or presence of a temperature more than 38 degree celcious or acute symptoms of infection greater than of mild severity on the day of vaccination
3. Participation or planned participation in a study involving the administration of an
investigational product within the past one month or during this study period.
4. A family history of congenital or hereditary immunodeficiency.
5. Women who are pregnant, breast-feeding, or considering becoming pregnant. All
participants of childbearing potential must agree to use medically acceptable forms of
contraception from screening until 60 days post vaccination. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. The occurrence and severity of solicited local and systemic reactions

2. The occurrence, severity, and relatedness to vaccination of unsolicited adverse events 		 21 days following vaccination 
 
Secondary Outcome  
Outcome  TimePoints 
Geometric mean titers (GMTs)   Day 1, 85 and 181 
Neutralizing antibodies  Day 85 and Day 181 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   01/02/2024 
Date of Study Completion (India) 10/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 seamless Phase 1/2, multi-center, double-blind, randomized, placebo-controlled clinical trial to be performed initially in healthy adults of 18 to 60 years of age (n=45) and then followed in children of >=2 to <18 years of age (n=75). The study will have two groups: Dengusiil and Placebo given to participants randomized in 2:1 ratio. Each participant will receive a single subcutaneous (SC) injection of either Dengusiil or placebo and will be followed up for 180 days after the vaccination. 
 
Close