CTRI

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CTRI Number

CTRI/2025/12/098806 [Registered on: 10/12/2025] Trial Registered Prospectively

Last Modified On:

15/06/2026

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Vaccine

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A clinical study to assess protection against Chickenpox and also to assess the safety and immunogenicity of Varicella vaccine (BARYCELA) in healthy children between age group 12 months and 12 years in India.

Scientific Title of Study

A Phase III, Multicentre, Randomized, Observer-blind, Active-controlled, Parallel group, Non inferiority Study to Evaluate Immunogenicity and Safety of Varicella vaccine (BARYCELA) in Healthy Pediatric Population 12 months to 12 years of age

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
DRL-VAR-008 (Protocol Ver 3.0 Dated 04 Sep 2024)	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Piyush Agarwal
Designation	Head, Clinical Development, Clinical Strategy
Affiliation	Dr. Reddy’s Laboratories Limited
Address	Integrated Product Development, Innovation Plaza, Survey No 42, 45 & 46, Bachupally Village, Bachupally Mandal, Medchal -Malkajgiri District, Hyderabad – 500 090, Telangana, India. Hyderabad TELANGANA 500090 India
Phone	919619097755
Fax
Email	piyushagarwal@drreddys.com

Details of Contact Person
Scientific Query

Name	Dr Sonika Newar
Designation	General Manager- Medical Monitoring and Safety
Affiliation	JSS Medical Research Asia pacific Private Limit
Address	JSS Medical Research Asia Pacific Private Limited, Tower 2, 1st Floor, South Wing, L&T Business Park, Faridabad HARYANA 121003 India
Phone	08800799887
Fax
Email	Sonika.newar@jssresearch.com

Details of Contact Person
Public Query
Modification(s)

Name	neeraj.prasad@jssresearch.com
Designation	Director – Operations
Affiliation	JSS Medical Research Asia Pacific Private Limited
Address	JSS Medical Research Asia Pacific Private Limited, Tower 2, 1st Floor, South Wing, L&T Business Park, Faridabad HARYANA 121003 India
Phone	9930740633
Fax
Email	neeraj.prasad@jssresearch.com

Source of Monetary or Material Support

Dr. Reddy’s Laboratories Limited Integrated Product Development, Innovation Plaza, Survey No 42, 45 & 46, Bachupally Village, Bachupally Mandal, Medchal -Malkajgiri District, Hyderabad – 500 090, Telangana, India.

Primary Sponsor

Name	Dr. Reddy’s Laboratories Limited
Address	Integrated Product Development, Innovation Plaza, Survey No 42, 45 & 46, Bachupally Village, Bachupally Mandal, Medchal -Malkajgiri District, Hyderabad – 500 090, Telangana, India.
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
Ms Dr Reddys Laboratories Limited	M/s Dr Reddys Laboratories Limited, 8-2-337, Road No. 3 Banjara Hills Hyderabad (India) - 500034 Telephone No.: 04044346200, 04044346572 FAX: 04044346285 E-Mail : MADHAVIK@DRREDDYS.COM.

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 Joseph John	AIIMS Bhubaneswar	AIIMS Bhubaneswar, Dept of Pediatrics, Ground floor, Room no-32, Sijua, Patrapada, Bhubaneswar, Odisha-751019, India Khordha ORISSA	7559936936 ped_joseph@aiimsbhubaneswar.edu.in
Dr Urmila Dahake	AIIMS Nagpur	Dept Of Paediatrics All India Institute Of Medical Sciences 2nd floor Plot no 2, Sector 20, MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra 441108 Nagpur MAHARASHTRA	9881150353 drurmilachauhan@aiimsnagpur.edu.in
Dr Jai Prakash Narayan	Jawahar Lal Nehru Medical College	Pediatric department, Ground floor, room no.- NA Jawahar Lal Nehru Medical College, Kala Bagh, Ajmer-305001, Rajasthan Ajmer RAJASTHAN	9314294402 jpnarayan.jln@gmail.com
Dr Anand Kawade	KEM Hospital Research Centre	Vadu Rural Health Program Floor Number: Ground Floor Room number: Not applicable Address: At Post Vadu (Budruk), Taluka-Shirur, District-Pune Pin-412216 State-Maharashtra Pune MAHARASHTRA	9850559983 askawade@yahoo.com
Dr Mohit Poddar	Maharaja Agrasen Superspecialty Hospital Central Spine,	Maharaja Agrasen Superspeciality Hospital, Clinical research department, Floor-, basement, room no. B-10, Sector-7, Central Spine, Vidyadhar Nagar, Jaipur 302039 Jaipur RAJASTHAN	9829666655 drmohitpoddar@gmail.com
Dr Jog Pramod Prabhakar	Medipoint Hospitals Pvt. Ltd.	Department of Paediatrics, Room No 1, First Floor, OPD Building, Medipoint Hospitals Pvt. Ltd., 241/1, New D. P. Road, Aundh, Pune-411007, Maharashtra, India. Pune MAHARASHTRA	9875469822 drpramod.medipoint@gmail.com
Dr Nitish Kumar	Mitra’s Multispecialty Hospital	Mitra’s Multispecialty Hospital Ground Floor Room No.03 1, Tilak Road ward No.12, Hakimpara, Siliguri District-Darjeeling West Bengal,734001 Darjiling WEST BENGAL	9433729947 drnitish_kumar@yahoo.co.in
Dr Savita Verma	PGIMS- Rohatak	Director Office, IIIrd Floor, Room no. 428, Department of Pharmacology, PGIMS Rohtak, Haryana-124001, India Rohtak HARYANA	9812283746 savita_verma@hotmail.com
Dr Hetal Vora	Shardaben Chimanlal Lalbhai Municipal General Hospital	Department of Paediatrics, Room 13, Special Ward, 2nd floor, Saraspur, Ahmedabad-380018, Gujarat Ahmadabad GUJARAT	9925011369 hetalsmtscl@gmail.com
Dr G Bala Kishor	St. Theresas Hospital,	St. Theresas Hospital, Sanathnagar, Hyderabad, Telangana, India-500018 Hyderabad TELANGANA	9949046236 Baki2004@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 10
Name of Committee	Approval Status
Institutional Ethics Committee for Clinical Trial All India Institute of Medical Sciences, Nagpur	Approved
-KEM Hospital Research Centre Ethics Committee KEM Hospital Research Centre-Moodliar Road, Rasta Peth Pune, Maharashtra - 411011 India	Approved
Ethics committee St Theresa’s Hospital Sanathnagar, Opp. Erragadda Raitu Bazar Hyderabad, Telangana - 500018 India	Approved
IEC, Maharaja Agrasen Hospital Maharaja Central Spine , Agrasen Aspatal Marg Sector 7,Vidhyadhar Nagar, Jaipur Jaipur Rajasthan – 302039, India	Approved
INSTITUTIONAL ETHICS COMMITTEE, Faculty Research, AlIMS Bhubaneswar All India Institute of Medical Sciences, BBSR AIIMS Bhubaneswar Sijua P/O Patrapada, Bhubaneswar Khordha Orissa - 751019 India	Approved
Institutional Ethics Committee, Jawahar Lal Nehru Medical College	Approved
Institutional Ethics Committee, NHLIEC Smt. NHL Municipal Medical College V S Hospital Campus, Ellisbridge, Ahmedabad Ahmedabad Ahmedabad Gujarat - 380006 India	Approved
Institutional Ethics Committee, Pt. BD Sharma, Post Graduate Institute Of Sciences PGIMS UHS Rohtak-Rohtak Haryana - 124001 India	Approved
Penta-Med Ethics Committee Medipoint Hospitals Pvt.Ltd 241/1, New D.P.Road, Near Sai Heritage,Aundh Pune Pune Maharashtra - 411007 India	Approved
Siliguri Sumita Cancer R.W And E. Society Ramkrishna Vedanta Ashrama Sarani, Pradhan Nagar W/O-2, SLG-3 Siliguri Darjeeling West Bengal - 743004 India	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Healthy Human Volunteer

Intervention / Comparator Agent

Type	Name	Details
Intervention	BARYCELA	Powder and solvent for injection to be given subcutaneously. Dose: Single dose of 0.5 ml for 1 Day only.
Comparator Agent	VARIPED®	Powder and solvent for injection to be given subcutaneously. Dose: Single dose of 0.5 ml for 1 day only.

Inclusion Criteria

Age From	12.00 Month(s)
Age To	12.00 Year(s)
Gender	Both
Details	1. Healthy participants of either sex aged 12 months to 12 years. 2. Be in good health based on medical history and as per Investigator judgment. 3. Informed consent,assent of the participant , parents, LAR and their willingness to be followed up for entire study period. 4. Parents, LAR with adequate literacy to fill the participant diary cards. Age of participant should be 12 completed months

ExclusionCriteria

Details

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Centralized

Blinding/Masking

Investigator Blinded

Primary Outcome

Outcome	TimePoints
Immunogenicity Proportion of participants who achieve seroconversion at Day 42 after vaccination. Seroconversion: The appearance of antibody titer of 1:4 or higher from seronegative status will be considered as seroconversion at Day 42 after vaccine administration.	Immunogenicity Proportion of participants who achieve seroconversion at Day 42 after vaccination. Seroconversion: The appearance of antibody titer of 1:4 or higher from seronegative status will be considered as seroconversion at Day 42 after vaccine administration.

Secondary Outcome

Outcome	TimePoints
Immunogenicity: • Geometric mean titer (GMT) at Day 1 (pre-vaccination) and Day 42 postvaccination • 4- Fold Seroconversion (antibody rise) rate at Day 42 post vaccination in test and reference arm • Geometric mean fold rise (GMFR) from Day 1 (pre-vaccination) to Day 42 (post vaccination) in test and reference arm	Day 42 after vaccination.

Target Sample Size

Total Sample Size="600"
Sample Size from India="600"
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)

27/04/2026

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="1"
Months="3"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

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 will be a Multicentre, Randomized, Observer -blind, Active-controlled, Parallel group, Non-inferiority Study to Evaluate Immunogenicity and Safety of Varicella vaccine (BARYCELA) in Healthy Pediatric Population 12 months to 12 years of age.

The study will enroll approximately 600 healthy pediatric participants to receive single dose of either test product Varicella vaccine (live attenuated) of Dr. Reddy’s Laboratories Limited or reference VARIPED® Vaccine (Varicella Vaccine Live I.P By MSD Pharmaceuticals Pvt Ltd, India) in 1:1 ratio. Participants aged 12 months to 12 years who give their assent as applicable to participate in the study and whose parents/legally authorized representatives (LARs) are willing to give informed consent will be included in the study.

Prospective participants will be screened and assessed for safety and eligibility to participate in the study, including assessment of medical history, vital signs and physical examination (PE) will be randomized and receive the vaccination (visit 1). Participants would be observed for at least 30 minutes at study site for any adverse events. Thereafter, enrolled participants would be followed up telephonically on visits scheduled on: day 7 (± 3) (visit 2) and day 21 (± 3) (visit 3). Subsequently, physical onsite visit will be conducted on day 42 (+7) which will be end of study visit.

All study participants will receive 1 single dose of either test or reference vaccine as per their randomization arm on Visit 1 (Day 1).