CTRI

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CTRI Number

CTRI/2025/06/088685 [Registered on: 12/06/2025] Trial Registered Prospectively

Last Modified On:

21/08/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Vaccine

Study Design

Other

Public Title of Study

study to assess the safety and immune response of VaxiRab N® (rabies vaccine) for prophylaxis against rabies.

Scientific Title of Study

An open-label, multicentre, phase IV clinical study to assess the safety and immunogenicity of VaxiRab N® administered for prophylaxis against rabies.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
Protocol No.: VAXI.24.002 Version: 01 Date: 27 Sep 2024	Protocol Number

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

Name	Dr Dharmesh Domadia
Designation	Vice President Global Clinical Operation
Affiliation	Cliantha Research Limited
Address	Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India Ahmadabad GUJARAT 382210 India
Phone	9879590828
Fax
Email	ddomadia@cliantha.com

Details of Contact Person
Scientific Query

Name	Dr Ankesh Barnwal
Designation	Associate Director II - Clinical Trial Medical Services
Affiliation	Cliantha Research Limited
Address	Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India Ahmadabad GUJARAT 382210 India
Phone	07966219500
Fax
Email	abarnwal@cliantha.com

Details of Contact Person
Public Query

Name	Mr Devesh Verma
Designation	Director - Clinical Trials
Affiliation	Cliantha Research Limited
Address	Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India Ahmadabad GUJARAT 382210 India
Phone	9712908404
Fax
Email	dverma@cliantha.com

Source of Monetary or Material Support

Zydus Lifesciences Limited, Plot Survey No. 23, 25/P, 37, 40/P, 42 To 47 Sarkhej-Bavla N.H. No-8A, Opposite Ramdev Masala, Village Changodar, Tal. Sanand, Ahmedabad – 382213, Gujarat, India

Primary Sponsor

Name	Zydus Lifesciences Limited
Address	Plot Survey No. 23, 25/P, 37, 40/P, 42 To 47 Sarkhej-Bavla N.H. No-8A, Opposite Ramdev Masala, Village Changodar, Tal. Sanand, Ahmedabad – 382213, Gujarat, India
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor

Name	Address
Cliantha Research Limited	Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 35
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Chintan Patel	Aatman Hospital	Clinical Research Department, Clinical Research Room, 5, Anveshan Row House, Opp. Umiya Mata Mandir, Bopal - Ghuma Main Road, Bopal, Ahmedabad - 380058, Gujarat Ahmadabad GUJARAT	9825182251 drchintan.cr@gmail.com
Dr Arpit Jain	Artemis Hospital	Clinical Research Department, Clinical Research room, Head Internal Medicine, Artemis Hospital, Sector-51, Gurgaon- 122001, Haryana Gurgaon HARYANA	9811951225 Arpit@artemishospitals.com
Dr Girish K Sonwalkar	Belagavi Institute of Medical Sciences	Clinical Research Department, Clinical Research room , Dr B.R. Ambedkar Road, Sadashiv Nagar, Belagavi - 590001, Karnataka Belgaum KARNATAKA	9448144615 sonwalkargirish9@gmail.com
Dr Vijayalakshmi Kulgod	BHS Lakeview Hospital	Clinical Research Department, Clinical Research room , R.S. No. 73/7, C.T.S. No .:11888, Opp. Fort Lake, Gandhi Nagar, Belagavi - 590016, Karnataka Belgaum KARNATAKA	9480188782 vkulgod@yahoo.com
Dr Vishal Patil	Care Multi Speciality Hospital	Clinical Research Department, Clinical Research room, Kolte Arcade, Pune-Nagar Road, Wagholi, Pune - 412207, Maharashtra Pune MAHARASHTRA	8055088190 vishal.islampur@gmail.com
Dr Swayam Pragyna Parida	Department of Community Medicine and Family Medicine, All India Institute of Medical Sciences	Clinical Research room, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneshwar Khordha ORISSA	9438884019 cmfm_swayam@aiimsbhubaneshwar.edu.in
Dr D Surendra Babu	Department of Community Medicine ESIC Medical College and Hospital	Department of Community Medicine, Clinical Research room , Sanathnagar, Hyderabad - 500038, Telangana Hyderabad TELANGANA	9490923248 surya.doc.2@gmail.com
Dr Chandan Das	Department of Medicine, Institute of Medical Science	Clinical Research Department, Clinical Research room , SUM Hospital, K8, Kalinga Nagar, Ghatikia, Bhubaneswar- 751003, Odisha Khordha ORISSA	9937063390 drchandan.trial@gmail.com
Dr Amul N Bhedi	GMERS Medical College and Hospital Gotri	Clinical Research Department, Clinical Research room, Gotri Road, Old TB Campus, Vadodara 390021, Gujarat Vadodara GUJARAT	9426569625 amul_bhedi@yahoo.com
Dr K Sunil Naik	Government Medical College and Government General Hospital	Clinical Research Department, Clinical Research room, Srikakulam - 532001, Andhra Pradesh Srikakulam ANDHRA PRADESH	9440828299 drsunilnaikggh@gmail.com
Dr Sumit Poddar	H.P. Poddar Memorial Clinic and Nursing Home	Room no. 101, Clinical Research Room, 56th Dr. Suresh Chandra Banerjee Road, Kolkata - 700010, West Bengal Kolkata WEST BENGAL	9830599468 drsumitpoddar@gmail.com
Dr Bakulesh Madhu	Harshil Medical Nursing Home	First Floor: Clinical Research Department (Room No. 101), 19, Aasha Society, Near Verayi Mata Mandir, Isanpur, Ahmedabad - 382443, Gujarat, India Ahmadabad GUJARAT	9824045708 hmnhcr@gmail.com
Dr Vishal Sambada	HCC Multispeciality Hospital	Clinical Research Department, Clinical Research room, 4th Floor, 302,303,305 &407, Shital Varsha Mall-5, Shivaranjani Cross Road, Satellite, Ahmedabad - 380015, Gujarat Ahmadabad GUJARAT	9724534598 vishalsambada.cr@gmail.com
Dr Parth Rathod	Health 1 Super Speciality Hospital	Clinical Research Department, Clinical Research room, Near Venitian Villa, Shilaj Circle, S.P. Ring Road, Thaltej, Ahmedabad-380059, Gujarat Ahmadabad GUJARAT	9408130618 parth.cr23@gmail.com
Dr Lisa Sarangi	Hi-Tech Medical College & Hospital	Clinical Research Department, Clinical Research room, Hi-Tech Medical College & Hospital, Health Park, Pandra, Rasulgarh, Bhubaneswar – 751025, Odisha Khordha ORISSA	9437165488 sarangilisa@gmail.com
Dr Richa Giri	Kailash Pant Singhania Post Graduate, LLR Hospital, GSVM Medical College	Department of Medicine, Clinical Research room, Swaroop Nagar, Kanpur - 208002, Uttar Pradesh Kanpur Nagar UTTAR PRADESH	8400331045 richa.227@rediffmail.com
Dr Milind M Vaishnav	Kamalnayan Bajaj Hospital	Clinical Research Department, Clinical Research room , Gut No 43, Satara Parisar, Beed Bypass Road, Aurangabad - 431010, Maharashtra Aurangabad MAHARASHTRA	9011030542 milind.vaishnav@gmail.com
Dr D Himanshu	King Georges Medical University	Clinical Research Department, Clinical Research room, Chowk, Lucknow 226003, Uttar Pradesh Lucknow UTTAR PRADESH	9839266822 dr.himanshu.reddy@gmail.com
Dr Madhav Prabhu	KLEs Doctor Prabhakar Kore Hospital and MRC	Belagavi -590010, Karnataka, India Belgaum KARNATAKA	9341101268 maddy2380@gmail.com
Dr Mohit Agarwal	Manglam Plus Medicity Hospital	Clinical Research Department, Room No 236, Second Floor, Shipra Path, Sector 5 Mansarovar, Jaipur - 302020, Rajasthan Jaipur RAJASTHAN	9913908645 mohitpharmacologist@gmail.com
Dr Dinesh Agrawal	Marwari Hospitals	Clinical Research Department, Clinical Research room , Marwari Hospitals, B3, Sati Joymati Road, Athgaon, Guwahati - 781008, Assam Kamrup ASSAM	9864061456 drdinesh944@gmail.com
Dr A Gopal Rao	Medigene Multispeciality Hospital Private Limited (Akshaya Hospital)	Clinical Research Department, D.No.43- 9- 201, Sr. No. 321-323, Railway New Colony, Visakhapatnam- 530016, Andhra Pradesh Visakhapatnam ANDHRA PRADESH	9440122790 drgopalraoa@gmail.com
Dr Bulle Ajay Abhimanyu	Meditrina Institute of Medical Sciences	Clinical Research Department, Clinical Research room, Meditrina Institute of Medical Sciences, 278, Central Bazar, Ramdaspeth, Nagpur , Maharashtra Nagpur MAHARASHTRA	9921981109 ajaybulle@yahoo.com
Dr Shobha Salve	MGM Medical College and Hospital	Pharmacology Department, Clinical Research room, 4th Floor, N-6 – CIDCO, Aurangabad - 431003, Maharashtra Aurangabad MAHARASHTRA	9822631670 drshobhasalve@gmail.com
Dr Jayesh Dutt	Narendra Modi (AMC MET) Medical College, LG Hospital	Clinical Research Department, Clinical Research room, LG Hospital, Maninagar, Ahmedabad - 380008,Gujarat Ahmadabad GUJARAT	9426008607 jayeshdutt@rediffmail.com
Dr N Ravi Kumar	Niloufer Hospital (Affiliated to Osmania Medical College)	Clinical Research Department, Clinical Research room, Niloufer Hospital (Affiliated to Osmania Medical College), Red Hills, Lakdikapul, Hyderabad-500004,Telangana Hyderabad TELANGANA	9490919293 ravik1961@yahoo.com
Dr Dipanjan Bandyopadhyay	North Bengal Medical College and Hospital	Clinical Research Department, Clinical Research room, 1st Floor, Susrutanagar, Siliguri, Darjeeling - 734012, West Bengal Darjiling WEST BENGAL	9433083913 dipanjanbandyo@gmail.com
Dr Jay Soni	Parth Hospital	Clinical Trial Department, Clinical Trial room, 4th Floor, E 405/4, 407-411, Fourth Floor Galaxy Arcade, Near Galaxy Cinema, Naroda, Ahmedabad - 382330, Gujarat Ahmadabad GUJARAT	9898003433 drjaysonict@gmail.com
Dr Himanshu Prajapati	PHC-Prajna Healthcare	Clinical Research Department, 205 - 208, 2nd Floor, Agam Avenue, Near Adani CNG Pump, Sabarmati, Ahmedabad - 380005, Gujarat Ahmadabad GUJARAT	9925075607 himanshupcr@gmail.com
Dr Ganesh Bansod	Radiant Super speciality Hospital	Clinical Research Department, Clinical Research room , Radiant Rehabilitation Building, Sabnis Plot, Kalyan Nagar, Amravati-444606, Maharashtra Amravati MAHARASHTRA	9975628583 savansamravati@gmail.com
Dr Babu Lal Meena	Sardar Patel Medical College and AG Hospitals	Department of General Medicine, Clinical Research room, PBM Hospital, Sardar Patel Medical College and AG Hospitals, Bikaner - 334003, Rajasthan Bikaner RAJASTHAN	9414909112 doctorblmeena@gmail.com
Dr Pragnya Paramita Das	SCB Medical College and Hospital	Clinical Research Department, Clinical Research room, SCB Medical College and Hospital, Cuttack - 753007, Odisha Cuttack ORISSA	9658044889 paramita.pragyana92@gmail.com
Dr Ashok Pardeshi	Shree Pragati Foundations Hira Mongi Navneet Hospital	Basement, Clinical Research Room, Clinical Research Department, Valji Ladha Road, Near Kalidas Natya Gruh, Mulund West, Mumbai-400080, Maharashtra, India Mumbai MAHARASHTRA	9850044954 ashoksidd1963@gmail.com
Dr S Rajendra Prasad	Sir Ronald Ross Institute of Tropical and Communicable Diseases	Clinical Research Department, Clinical Research room , Nallakunta Main Road, Nallakunta, Hyderabad – 500044, Telangana Hyderabad TELANGANA	9849077552 rpsuram@gmail.com
Dr Bharat Das	Sparsh Hospital and Criticare (P) Ltd	Clinical Research Department, Clinical Research room, Sparsh Hospital and Criticare (P) Ltd. Plot No. A/407, Sahid Nagar, Bhubaneswar-751007, Odisha Khordha ORISSA	9938190845 bharatdas74@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 35
Name of Committee	Approval Status
AMC MET Ethics Committee, AMC MET Medical College and Seth LG Hospital	Submittted/Under Review
Artemis Health Science Institutional Ethics Committee	Submittted/Under Review
BHS Lakeview Ethics Committee	Approved
Care Multi Speciality Hospital Ethics Committee	Submittted/Under Review
Ethics Committee, GSVM Medical College	Approved
Ethics Committee, Kamalnayan Bajaj Hospita	Submittted/Under Review
Ethics Committee, SP Medical College	Submittted/Under Review
Health 1 Super Speciality Hospital Ethics Committee	Submittted/Under Review
Institutional Ethics Committee Aatman Hospital	Approved
Institutional Ethics Committee ECRC-HEC	Submittted/Under Review
Institutional Ethics Committee H.P. Poddar Memorial Clinic & Nursing Home	Approved
Institutional Ethics Committee Hira Mongi Navneet Hospital	Approved
Institutional Ethics Committee, All India Institute of Medical Sciences	Submittted/Under Review
Institutional Ethics Committee, Belagavi Institute of Medical Sciences	Submittted/Under Review
Institutional Ethics Committee, ESIC Medical College and Hospital,	Submittted/Under Review
Institutional Ethics Committee, Government Medical College and Government General Hospital	Submittted/Under Review
Institutional Ethics Committee, HiTech Medical College & Hospital	Submittted/Under Review
Institutional Ethics Committee, Institute of Medical Sciences & SUM Hospital, K8, Kalina Nagar, Ghatikia	Approved
Institutional Ethics Committee, King George’s Medical University	Submittted/Under Review
Institutional Ethics Committee, KLE University	Approved
Institutional Ethics Committee, Medigene Multispeciality Hospital Private Limited (Akshaya Hospital)	Approved
Institutional Ethics Committee, Osmania Medical College	Submittted/Under Review
Institutional Ethics Committee, Osmania Medical College	Submittted/Under Review
Institutional Ethics Committee, SCB Medical College and Hospital	Submittted/Under Review
Institutional Ethics Committee, Sparsh Hospital and Criticare (P) Ltd	Approved
Institutional Human Ethics Committee,GMERS Medical College and Hospital Gotri	Submittted/Under Review
Manglam Plus Medicity Hospital Institutional Ethics Committee	Approved
Meditrina Institutional Ethics Committee	Submittted/Under Review
MGMs Ethics Committee for Research on Human Subjects	Approved
Netaji Polyclinic Institutional Ethics Committee	Approved
North Bengal Medical College Institutional Human Ethics Committee	Approved
Parth Hospital Institutional Ethics Committee	Approved
Parth Hospital Institutional Ethics Committee	Approved
Radiant Super Speciality Hospital Ethics Committee	Approved
Riddhi Medical Nursing Home IEC	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: Z291\|\|Encounter for prophylactic immunotherapy,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	NA	NA
Intervention	VaxiRab N®	Pre-exposure prophylaxis (PrEP): PrEP consists of a series of 3 doses of 1 ml each administered IM day 0 (visit 1), day 7 (visit 3) and day 28 (visit 5). The vaccine should be administered in the deltoid region, however, in the case of small children (less than 2 years), the vaccine can be alternatively administered in the anterolateral aspect of the thigh. Post-exposure prophylaxis (PEP) A. Intramuscular Route (Essen regimen) - PEP consists of a series of 5 doses of 1 ml each administered IM on day 0 (visit 1), day 3 (visit 2), day 7 (visit 3), day 14 (visit 4) and day 28 (visit 5). The vaccine should be administered in the deltoid region, however, in the case of small children (less than 2 years), the vaccine can be alternatively administered in the anterolateral aspect of the thigh. Rabies immunoglobulin to be administered along with the vaccine for WHO category III animal bites. B. Intradermal Route (Updated Thai Red Cross regimen) - PEP consists of series of 4 doses of 0.2 ml each (0.1 ml at 2 different sites having different lymphatic drainage, preferably left and right upper arms) administered ID on day 0 (visit 1), day 3 (visit 2), day 7 (visit 3) and day 28 (visit 5). Rabies immunoglobulin to be administered along with the vaccine for WHO category III animal bites. For the purpose of this clinical trial, in order to maintain proper accountability of investigational products, one vaccine vial will be used for vaccination of one participant only. Reconstituted vaccine remaining in the vial after intradermal use will not be used for any other participant.

Inclusion Criteria
Modification(s)

Age From	1.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	1. Healthy subjects for pre-exposure prophylaxis or subjects with WHO category II or III animal bites for post-exposure prophylaxis against rabies 2. Written informed consent and assent (if applicable) from adult subjects or parents of minor subjects (less than 18 years) 3. Participants or parents of participants with adequate literacy to fill the diary. Category II - nibbling of uncovered skin, minor scratches or abrasions without bleeding, licks on broken skin Category III – single or multiple transdermal bites or scratches, contamination of mucous membrane with saliva from licks; exposure to bat bites or scratches

ExclusionCriteria

Details

1. History of anaphylaxis or serious reactions to other vaccines

2. History of suturing of the wound or application of irritants at the wound site

3. Participants with any clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological, or immunological disorder

4. History of any serious chronic illness or immunosuppression (immunosuppressive illness or therapy) or on steroids

5. Subjects with any acute febrile illness (body temperature greater than or equals to 37.5°C) at the time of enrolment

6. Pregnant or lactating women or planning to become pregnant in the next one year

7. Participation in any clinical trial in the last 3 months

8. Patient with history of drug or alcohol abuse

9. Received any type of rabies vaccine or any dose of rabies immunoglobulin in the past

10. Treated with antimalarial drugs in last 2 months

11. Received blood, blood products, or immunoglobulins during the preceding 3 months

12. Any other vaccine administration within 30 days of initiation of the study

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Other

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To assess the safety profile of VaxiRab N® administered for prophylaxis against rabies	Week 1, Week 2, Week 4

Secondary Outcome

Outcome	TimePoints
To evaluate the immunogenicity of VaxiRab N® in a subset of 10 percent of subjects	1. Proportion of participants who achieve antibody titre greater than or equals to 0.5 IU/mL on day 0, at week 2 and at week 4. 2. Geometric mean titre of rabies virus neutralizing antibodies on day 0, at week 2 and at week 4.

Target Sample Size

Total Sample Size="3000"
Sample Size from India="3000"
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 4

Date of First Enrollment (India)

30/06/2025

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="0"
Days="0"

Recruitment Status of Trial (Global)

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

An open-label, multicentre, phase IV clinical study to assess the safety and immunogenicity of VaxiRab N® administered for prophylaxis against rabies.