FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/089129 [Registered on: 19/06/2025] Trial Registered Prospectively
Last Modified On: 11/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A research study on Typhoid Conjugate Vaccine manufactured by Serum Institute for the treatment of Typhoid and Paratyphoid treatment in the Indian participants between 6 months to 65 years of age, to check the effect of Typhoid vaccine in Indian Participants. 
Scientific Title of Study   A Phase 2/3, Double-Blind, Randomized, Active-Controlled, Multicentric study to evaluate the Safety, Immunogenicity and Lot-to-Lot consistency of a bivalent conjugate vaccine against Salmonella enterica serovars Typhi and Paratyphi A in healthy individuals aged 6 months to 65 years 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol No: TCV-02 Version 1.0 dated 21 Oct 2024  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 
Designation  Executive Director 
Affiliation  Serum Institute of India Private, 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  912071946820  
Fax    
Email  drpsk@seruminstitute.com  
 
Details of Contact Person
Public Query  
Name  Dr Prasad Kulkarni 
Designation  Executive Director 
Affiliation  Serum Institute of India Private, 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  912071946820  
Fax    
Email  drpsk@seruminstitute.com  
 
Source of Monetary or Material Support  
Nil 
 
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
Modification(s)  
No of Sites = 16  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hira Lal Bhalla  All India Institute of Medical Sciences, Gorakhpur  All India Institute of Medical Sciences, Opp Army Public School, Kunraghat, Gorakhpur, Uttar Pradesh - 273008
Gorakhpur
UTTAR PRADESH 		 00915512205501

hirabhalla@gmail.com 
Dr Shailesh Patil  Belgavi Institute of Medical Sciences, Belgavi  Department of Pediatrics, Belgavi Institute of Medical Sciences, Dr. B.R Ambekar Road, Belgavi Karnataka-590001
Belgaum
KARNATAKA 		 00919480454944

shaileshpt@yahoo.com 
Dr Vineet Jain  Clinical Research Centre - HIMSR with SAS  Clinical Research Centre - HIMSR with SAS Block- B, Basement, Hamdard Institute of Medical Sciences and Research (HIMSR) with Society for Applied Studies(SAS), Hakeem Abdul Hameed Centenary Hospital (HAHCH), Guru Ravidas Marg, Hamdard Nagar, New Delhi - 110062, India
West
DELHI 		 00919999074056

dr.vineet83@yahoo.in 
Dr Indranil Saha  ICMR-National Institute for Research in Bacterial Infections ICMR-NIRBI  ICMR-National Institute for Research in Bacterial Infections (ICMR-NIRBI) Division of Epidemiology, P33, CIT Road, Scheme XM, Beliaghata, Kolkata 700010, West Bengal, India
Kolkata
WEST BENGAL 		 03323633373

drsahaindranil@gmail.com 
Dr Kheya Ghosh Uttam  Institute of Child Health  Room No. 113, Project Room, Ground Floor, Institute of Child Health, 11 Dr. Biresh Guha Street, Kolkata, West Bengal, India 700017
Kolkata
WEST BENGAL 		 009103322905686

kheya.ghosh.uttam@gmail.com 
Dr M D Ravi  JSS Medical College  Department of Community Diseases JSS Medical College, JSS Hospital, MG Road, Mysuru - 570004 Karnataka, India
Mysore
KARNATAKA 		 009108212335555

ravimdped@gmail.com 
Dr Sonali Kar  Kalinga Institute of Medical Sciences  Clinical Epidemiological Unit, OBG and Paediatrics Block, Kalinga Institute of Medical Sciences, Near Immunization, Campus 5, KIIT University, Patia, Bhubaneswar, Odisha - 751024
Khordha
ORISSA 		 009106747111000

sonsam72@yahoo.co.uk 
Dr Anand Shantaram Kawade  KEM Hospital Research Centre, Pune  KEM Hospital Research Centre, Vadu Rural Health Program, Vadu Budruk, Taluka Shirur, District - Pune 412216, Maharashtra, India
Pune
MAHARASHTRA 		 02137-252234

askawade@yahoo.com 
Dr Bheemisetty S Chakravarthy  King George Hospital, Visakhapatnam  King George Hospital, Department of Pediatrics, 1st Floor Near Collectorate Junction, Maharanipeta, Visakhapatnam – 530002, Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH 		 08912564891

chakravarthy.kghamc@gmail.com 
Dr Sudhir Pawar  Lokmanya Tilak Municipal Medical College and General Hospital  Room No. 03, 2nd floor, Department of Pharmacology, College Building, Lokmanya Tilak Municipal Medical College and General Hospital, Sion, Mumbai - 400022
Mumbai
MAHARASHTRA 		 00912224063162

dr.sudhirpawar@gmail.com 
Dr Ritesh Jain  Marwari Hospital, Guwahati, Assam  Marwari Hospitals, Sati Joymati Road, Athgaon, Guwahati Kamrup Metropolitan - Assam- 781008, India
Kamrup
ASSAM 		 9435030717

riteshdrghy@gmail.com 
Dr Uma Muralidharan V  Meenakshi Mission Hospital & Research Centre  Department of Pediatrics, Meenakshi Mission Hospital and Research Centre, Lake Area, Melur Road, Madurai - 625107 Madurai, Tamil Nadu, India
Madurai
TAMIL NADU 		 00919385596139

muralidharan_uma@yahoo.com 
Dr Savita Verma  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences - PGIMS, Rohtak  Room No. 428, Department of Pharmacology, Pt. B. D. Sharma, Post Graduate Institute of Medical Sciences, University of Health Sciences/UHS, Rohtak- 124001
Rohtak
HARYANA 		 09812283746

verma.savi@gmail.com 
Dr Madhuri Agrawal  Radiant Superspeciality Hosptial, Amravati  Radiant Superspeciality Hosptial Sabnis Plot, Kalyan Nagar Square, Amravati (MH) 444606
Amravati
MAHARASHTRA 		 00919225224289

drmadhuri2006@yahoo.com 
Dr Nithya Gogtay  Seth G.S Medical College and KEM Hospital  Department of Clinical Pharmacology, Seth G. S. Medical College and KEM Hospital, Acharya Donde Marg, Mumbai - 400012, Maharashtra, India
Mumbai
MAHARASHTRA 		 00912224133767

nigogtay@hotmail.com 
Dr Balaji Chinnasami  SRM Medical College Hospital and Research Centre, Chengalpattu  SRM Medical College Hospital and Research Centre, SRM Centre for Clinical Trials and Research, 3rd floor, E Block Extension, SRM Medical College Hospital &Research Centre, SRM Nagar, Kattankulathur - 603203, Chengalpattu District, Tamil Nadu, India.
Kancheepuram
TAMIL NADU 		 00919445482710

balajic1@srmist.edu.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 15  
Name of Committee  Approval Status 
ECRC-HEC Marwari Hospitals, S J Road, Athgaon, Guwahati-781008,  Approved 
Institutional Ethics Commitee ICMR National Institute of Cholera and Enteric Diseases (IEC-ICMR-NICED) Kolkata  Submittted/Under Review 
Institutional Ethics Committee HIMSR and Associated HAH Centenary Hospital  Approved 
Institutional Ethics Committee Human Research, Lokmanya Tilak Municipal Medical College  Approved 
Institutional Ethics Committee Kalinga Institute of Medical Sciences  Approved 
Institutional Ethics Committee SRM Medical College Hospital and Research Centre  Approved 
Institutional Ethics Committee, Belgavi Institute of Medical Sciences, Belgavi  Approved 
Institutional Ethics Committee, Institute of Child Health  Submittted/Under Review 
Institutional Ethics Committee, JSS Medical College and Hospital, JSS Medical College, Mysore-57005, Karnataka, India  Approved 
Institutional Ethics Committee, King George Hospital,  Submittted/Under Review 
Institutional Ethics Committee, Pt. B.D. Sharma Post Graduate Institute of Medical Sciences,  Submittted/Under Review 
Institutional Ethics Committee, Seth GS Medical College and KEM Hospital, Mumbai  Approved 
KEM Hospital Research Center Ethics Committee  Approved 
Meenakshi Mission Hospital & Research Centre Ethics Committee  Approved 
Radiant Superspeciality Hospital Ethics Committee, Amravati  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Typhoid 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  SII-TCV(B)  A bivalent conjugate vaccine containing the Vi polysaccharide antigen from S. Typhi conjugated to purified tetanus toxoid (TT) carrier protein and the purified O-specific polysaccharide from S. Paratyphi A (OSP-A) conjugated to purified diphtheria toxoid (DT) carrier protein. A single dose of 0.5 mL contains: Purified Vi polysaccharide from Salmonella Typhi conjugated to Tetanus Toxoid (Vi-TT Conjugate) 25 microgram Purified O-Specific Polysaccharide from Salmonella Paratyphi A is conjugated to Diphtheria Toxoid (OSP- DT Conjugate) 25 microgram 
Comparator Agent  Typbar-TCV  A monovalent conjugate vaccine containing purified Vi-Capsular Polysaccharide of S. Typhi Ty2 conjugated to Tetanus Toxoid A single dose of 0.5 mL contains: Purified Vi-Capsular Polysaccharide of S. Typhi Ty2 conjugated to Tetanus Toxoid 25 microgram Sodium chloride 4.5 mg Water for Injection (WFI) 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or female participants aged between more than 6 months to less than 65 years
2. Normal health as determined by medical history and clinical examination.
3. Intend to remain residing near study area throughout study participation.
4. Female participants of childbearing potential with negative pregnancy test prior to IP
administration. 
 
ExclusionCriteria 
Details  1. History of S. Typhi or S. Paratyphi A infection.
2. Previous vaccination for typhoid fever
3. Planning to receive any vaccine until Day 29 post-vaccination.
4. Major congenital or genetic defect
5. Pregnant or lactating women
6. History or presence of significant alcoholism or drug abuse in the past one year. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Immediate adverse events within 30 minutes post-vaccination.
2.Solicited local and systemic adverse events up to Day 7 post-vaccination 		 1. 30 minutes post-vaccination
2. Day 7 post-vaccination 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the safety
and tolerability of SII-TCV(
B) to Typbar-TCV®. 		 1. IAEs within 30 minutes post-vaccination.
2. Solicited local and systemic AEs up to Day 7 postvaccination.
3. Unsolicited AEs up to Day 29 post-vaccination.
4. SAEs up to Day 181 post-vaccination 
 
Target Sample Size   Total Sample Size="2729"
Sample Size from India="2729" 
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 2/ Phase 3 
Date of First Enrollment (India)   07/07/2025 
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="2"
Months="0"
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   A Phase 2/3, Double-Blind, Randomized, Active-Controlled, Multicentric study to evaluate the Safety, Immunogenicity and Lot-to-Lot consistency of a bivalent conjugate vaccine against Salmonella enterica serovars Typhi and Paratyphi A in healthy individuals aged 6 months to 65 years. The Study will be conducted in 2 phases. Phase 2 will be conducted in 18 to 65 years age group, 150 participants. In Phase 3 Healthy male or female participants aged 6 months to 65 years will be divided into four age groups: 6 months to <2 years, 2 to < 10 years, 10 to < 18 years and 18 to 65 years. The study will have two groups SII-TCV (B) and Typbar-TCV given to participants randomized in 2:1 ratio. Either SII-TCV(B) or Typbar-TCV will be administered as single dose of 05.mL via intramuscular route to the participants. The participants will be followed up until 180 days after the vaccination.
 
Close