CTRI/2025/11/097033 [Registered on: 07/11/2025] Trial Registered Prospectively
Last Modified On:
10/08/2026
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
Ethics Committee of BMCRI,BAngalore Medical College and Research Institute,Fort,K R Road Bengaluru 560002
Approved
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
Institutional Ethics Committee,IMS and SUM Hospital,KalingaNagar,Shampur,Khorda 751003,Odisha,India
Approved
Riddhi Medical Nursing Home Institutional Ethics Committee,Riddhi Medical Nursing Home, A/101,Jalaram Plaza,Jawahar Chowk,Maninagar,Ahmedabad 380008
Approved
Sumandeep Vidyapeeth,Sumandeep,Vidyapeeth At and Post Pipariya Pipariya,Vadodara
Approved
Institutional Ethics Committee BIMS, Belagavi Institute Of Medical Sciences, Belagavi,Dr B R Ambedkar Road Belgaum Belgaum Belagavi (Belgaum) Karnataka - 590001 India
Approved
Research Cell, Administrative Block, King Georges Medical University. Shahmeena Road, Chowk, Lucknow-226003.
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
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