| CTRI Number |
CTRI/2025/11/097033 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A prospective, randomized, parallel, single-blind, two-arm, active-controlled,
multicentre, age de-escalation, phase II clinical trial |
|
Scientific Title of Study
|
A prospective, randomized, parallel, single-blind, two-arm, active-controlled,
multicentre, age de-escalation, phase II clinical trial to
evaluate the immunogenicity and safety of Bivalent Typhoid and
Paratyphoid A Conjugate Vaccine of M/s. Zydus Lifesciences Ltd.
as compared to Typhoid Vi Conjugate Vaccine of M/s. Zydus
Lifesciences Ltd. in healthy participants. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BTPT.24.001, Ver 01,21 January, 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deven Parmar |
| Designation |
Chief Medical Officer & Head – Clinical R & D |
| Affiliation |
Zydus Lifesciences Ltd |
| Address |
Zydus Research Center,Survey No. 396/403, Sarkhej-Bavla National Highway No. 8A,Moraiya
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
dparmar@zydustherapeutics.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pavankumar Daultani |
| Designation |
General Manager-Clinical R&D |
| Affiliation |
Zydus Research Centre |
| Address |
Survey No. 396/403, Sarkhej-Bavla National Highway No. 8A,Moraiya
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
pavankumar.daultani@zyduslife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavankumar Daultani |
| Designation |
General Manager-Clinical R&D |
| Affiliation |
Zydus Research Centre |
| Address |
Survey No. 396/403, Sarkhej-Bavla National Highway No. 8A,Moraiya
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
pavankumar.daultani@zyduslife.com |
|
|
Source of Monetary or Material Support
|
| Zydus Lifesciences Limited
Zydus Research Centre,
Survey No. 396/403,
Sarkhej-Bavla National Highway No. 8A Moraiya,
Ahmedabad – 382213, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Zydus Lifesciences Limited |
| Address |
Zydus Research Centre,
Survey No. 396/403,
Sarkhej-Bavla National Highway No. 8A Moraiya,
Ahmedabad – 382213, Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chandan Das |
Institute of Medical Science and SUM Hospital |
Department of Medicine, Institute of Medical Science and SUM Hospital, K8, Kalinga Nagar, Ghatikia, Bhubaneswar-751003, Odisha
Khordha
ORISSA |
9937063390
drchandan.trial@gmail.com |
| Dr Shreyans Shah |
Aatman Hospital |
5, Anveshan Row House, Opp. Umiya Mata Mandir,Bopal-Ghuma Main Road, Bopal, Ahmedabad-380058, Gujarat.
Ahmadabad
GUJARAT |
9909977831
drshreyans.cr@gmail.com |
| Dr Jyothi S Doshetty |
Belagavi Institute of Medical Sciences |
Belagavi Institute of Medical Sciences,Dr B.R. Ambedkar Road, Sadashiv Nagar, Belagavi – 590001, Karnataka.
Belgaum
KARNATAKA |
9611714885
drjyothipgbelgaum@gmail.com |
| Dr Javdekar Bakul Balchandra |
Department of Pediatrics, Dhiraj Hospital, SBKS MI & RC |
Department of Pediatrics, Dhiraj Hospital, SBKS MI & RC, At & Post: Piparia, Taluka: Waghodia, Vadodara-391760, Gujarat, India
Vadodara
GUJARAT |
9925014448
bjavadekar@rediffmail.com |
| Dr Ambuj Yadav |
King George’s Medical University |
King George’s Medical University, Shahmeena Road, Chowk, Lucknow-226003, Uttar Pradesh
Lucknow
UTTAR PRADESH |
9451631268
dr.ambujyadav@gmail.com |
| Dr Pravakar Mishra |
Sardar Vallabhbhai Patel Post Graduate Institute of Paediatrics & SCB MCH, Cuttack |
Cuttack, Odisha-753002,India
Cuttack
ORISSA |
9437028882
drpmishra61@gmail.com |
| Dr Shivaprakash S C |
Vani Vilas Hospital |
Vani Vilas Hospital, Bangalore Medical College and Research Institute, K R Road Fort, Bangalore 560002, Karnataka, India.
Bangalore
KARNATAKA |
7204776479
shivaprakashsosale@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| IEC SCB Medical College & Hospital, Cuttack, Odisha-753007, India |
Approved |
| Institutional Ethics Committee, Aatman Hospital, 5, Anveshan Row house, opp. Umiya mata mandir, Bopal-Ghuma Main Road, Bopal, Ahmedabad-380058, Gujarat |
Approved |
| Sumandeep Vidyapeeth, Sumandeep, Vidyapeeth At and Post Pipariya Pipariya,Vadodara Gujarat - 391760 India. |
Submittted/Under Review |
| Ethics Committee of BMCRI, BAngalore Medical College and Research Institute, Fort, K R Road Bengaluru 560002. |
Submittted/Under Review |
| Institutional Ethics Committee BIMS, Belagavi Institute Of Medical Sciences, Belagavi,Dr B R Ambedkar Road Belgaum Belgaum Belagavi (Belgaum) Karnataka - 590001 India |
Approved |
| K8, Shampur, Ghatikia, Bhubaneswar, 751003, Odisha, India. |
Submittted/Under Review |
| Research Cell, Administrative Block, King Georges Medical University. Shahmeena Road, Chowk, Lucknow-226003. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIl |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bivalent Typhoid and Paratyphoid A
Conjugate Vaccine of M/s. Zydus Lifesciences Ltd. |
Dose:0.5 ml
Route:Intramuscular
Duration:- Single dose
Frequency: Once |
| Comparator Agent |
Typhoid Vi Conjugate Vaccine of M/s.
Zydus Lifesciences Ltd. |
Dose:0.5 ml
Route:Intramuscular
Duration:- Single dose
Frequency: Once |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects of either gender of 6 months to 65 years of age (both inclusive).
2)Subjects should be in a good health as determined by the medical history and physical examination based on clinical judgment of the investigator
3)No previous history of vaccination (oral or injectable) against typhoid or paratyphoid fever
4)Informed consent from the adult subjects or from the parents of pediatric subjects.Additionally,assent from pediatric subjects aged 7 to less than 18 years.
5)Adult subjects or parents of pediatric subject should be literate enough to fill the diary card.
6)Men and women of childbearing potential must agree to use adequate birth control measures during the study. Acceptable methods of birth control in this study include surgical sterilization,intrauterine device, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, male partner’s vasectomy, double-barrier method (condom or diaphragm with spermicide) or abstinence for at least 4 weeks prior to vaccine administration, during study participation and for 30 days after vaccine administration. |
|
| ExclusionCriteria |
| Details |
1. History of hypersensitivity reaction or serious adverse event to any component of the vaccine
2. History of laboratory confirmed or suspected typhoid or paratyphoid fever in the past 3 years
3. Household contact with known exposure to an individual with laboratory confirmed or clinical diagnosis of typhoid or paratyphoid fever
4. Fever of any origin or infectious disorder of 3 days or more within the past month
5. Febrile illness (body temperature less than equal to 37.5°C) at the time of enrolment
6. History of any vaccination within the past month
7. Significant acute or chronic infection requiring systemic antibiotic treatment within the past month
8. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
9. Confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
10. Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
11. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
12. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
13. Subject participated in another clinical study in the past 3 months
14. Subject with history of alcohol or drug abuse in the past one year
15. Any other reason for which the investigator feels that subject should not participate
16. Female participants who are pregnant, currently breastfeeding, or attempting to conceive. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Seroconversion rate of anti-Vi IgG antibodies
and anti-LPS IgG antibodies |
Day 0 to Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Geometric mean titre of anti-Vi IgG antibodies
and anti-LPS IgG antibodies |
Day 0 and Day 28 |
Solicited local and systemic adverse
events |
Day 0 to Day 28 |
| Unsolicited adverse events |
Day 0 to Day 28 |
| Serious adverse events |
Day 0 to Day 28 |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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 |
|
Date of First Enrollment (India)
|
11/11/2025 |
| 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
|
The safety and immunogenicity of Bivalent Typhoid and Paratyphoid A Conjugate Vaccine of M/s. Zydus Lifesciences Ltd. (BTPTCV) was evaluated in a phase I clinical trial. In that study, the vaccine was found to be well tolerated and immunogenic when administered as single dose intramuscularly to healthy adults. The current phase II clinical trial is planned to evaluate the immunogenicity and safety of BTPTCV in the intended population including adults, children, toddlers and infants. The participants to be enrolled in the study will be aged 6 months to 65 years. The comparator vaccine, Typhoid Vi Conjugate Vaccine of M/s. Zydus Lifesciences Ltd. (TCV), is already approved for use in this age group |