CTRI/2024/01/061080 [Registered on: 02/01/2024] Trial Registered Prospectively
Last Modified On:
07/04/2026
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Vaccine
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
A clinical trial to evaluate the immunological non-interference of typhoid Vi conjugate vaccine with yellow fever vaccine administered to healthy subjects
Scientific Title of Study
A prospective, randomized, parallel, three-arm,
open-label, multicenter, phase IV clinical trial to
evaluate the immunological non-interference of
Typhoid Vi conjugate vaccine with Yellow fever
vaccine administered to healthy subjects
Trial Acronym
Indian
Secondary IDs if Any
Secondary ID
Identifier
23-01 Version No. 02 Dated 14/08/2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr Deven V Parmar MD FCP
Designation
Chief Medical Officer & Head – Clinical R & D
Affiliation
Zydus Lifesciences Limited
Address
Zydus Lifesciences Limited Zydus Research Centre, Survey No. 396/403, Sarkhej-Bavla National Highway No. 8A Moraiya
Zydus Lifesciences Limited Zydus Research Centre, Survey No. 396/403, Sarkhej-Bavla National Highway No. 8A Moraiya
Ahmadabad GUJARAT 328813 India
Phone
02717665555
Fax
Email
dparmar@zydustherapeutics.com
Details of Contact Person Public Query
Name
Dr Pavan Daultani
Designation
Deputy General Manager- New Product Development
Affiliation
Zydus Lifesciences Limited
Address
3rd Floor D Wing, Zydus Corporate Park, Nr. Vaishnodevi circle, SG
Highway, Ahmedabad. Zydus Corporate Park, Nr. Vaishnodevi
circle, SG Highway, Ahmedabad
Ahmadabad GUJARAT 382481 India
Phone
07948041430
Fax
Email
pavankumar.daultani@zyduslife.com
Source of Monetary or Material Support
Zydus Lifesciences Limited (Formerly known as Cadila Healthcare limited), Zydus Corporate park, Scheme no. 63, survey no. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi circle, S. G. Highway, Ahmedabad, 382481, Gujarat, India.
Primary Sponsor
Name
Zydus Lifesciences Limited
Address
Zydus Lifesciences Limited (Formerly known as Cadila Healthcare limited), Zydus Corporate park, Scheme no. 63, survey no. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi circle, S. G. Highway, Ahmedabad, 382481, Gujarat, India.
Clinical Research Room, Ground floor, Aatman Hospital, 5, Anveshan Row House, Opp Umiya Mata Mandir Bopal-Ghuma Main Road, Bopal Ahmedabad Ahmedabad Gujarat - 380058 India Ahmadabad GUJARAT
9825182251
drchintan.cr@gmail.com
Dr R G Viveki
Belagavi Institute of Medical sciences
Belagavi Institute of Medical sciences, Dr Ambedkar road Sadashiv Nagar, Belagavi 590001. Belgaum KARNATAKA
9845143860
rgviveki@gmail.com
Dr Neeta Hanumante
Bharati Vidyapeeth (Deemed to be University) Medical College & Hospital
Department of Pediatrics, Bharati Vidyapeeth (Deemed to be University) Medical College & Hospital, Katraj Dhankawadi,Pune-Satara Road,
Pune -411043,Maharashtra Pune MAHARASHTRA
9822031383
neetahanumante@gmail.com
Dr Lisa Sarangi
Hi-Tech Medical College and Hospital
First Floor, Professor
Room, Department of Community Medicine, Hi-Tech Hospital Road, Pandra, Rasulgarh, Bhubaneswar, Odisha-751025 Khordha ORISSA
9437165488
sarangilisa@gmail.com
Dr Monjori Mitra
Institute of Child Health
Institute of Child Health, 11, Dr. Biresh Guha Street, Kolkata-700017, West Bengal, India Kolkata WEST BENGAL
9831075734
monjorimr@gmail.com
Dr Jayaprakash Appajigol
KLES Dr Prabhakar Kore Hospital and Medical Research Center
OPD No. 11, Ground floor, Department of Medicine, KLES Dr Prabhakar Kore Hospital & Medical Research Centre, Nehrunagar, Belagavi -590010, Karnataka Belgaum KARNATAKA
Department of Medicine, MLB
Medical College & Associated
Hospital, Kanpur Road, Jhansi-
284128, Uttar Pradesh Jhansi UTTAR PRADESH
9450137367
drzaki.mlb@gmail.com
Dr Devang Rana
Sheth Vadilal Sarabhai General Hospital
Clincal research unit,Room number 8,burns ward,2nd floor, V.S. General Hospital, Nr Ellis bridge, Paldi,Ahmedabad, 380006, Gujarat, India. Ahmadabad GUJARAT
Active immunization against Typhoid with Yellow Fever
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Not applicable
Not applicable
Intervention
Typhoid Vi Conjugate Vaccine I.P. of M/s.
Zydus Lifesciences Limited & Yellow Fever Vaccine (WHO prequalified)
TCV: The vaccine will be available in the liquid form. A 0.5 ml single dose of the vaccine will be administered as an intramuscular injection in deltoid region or anterolateral aspect of the upper thigh (for children younger than 2 years) taking care of aseptic precautions.
YF vaccine: The vaccine will be available in the lyophilized form and it will be reconstituted with the diluent supplied along with the vaccine immediately prior to vaccination. The reconstituted 0.5 ml single dose of the vaccine will be administered as a subcutaneous injection in deltoid region or anterolateral aspect of the upper thigh (for children younger than 2 years) taking care of aseptic precautions.
In the test group, both TCV and YF vaccine will be administered concomitantly as separate injections in different arms/thighs.
Inclusion Criteria
Age From
9.00 Month(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Subjects of either gender of 9 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 fever or yellow fever
4. Informed consent from the adult subjects or from the parents of pediatric subjects. Additionally, assent from pediatric subjects aged 7 to <18 years
5. Adult subjects or parents of pediatric subjects literate enough to fill the diary card
ExclusionCriteria
Details
1. History of hypersensitivity reaction to any component of the study vaccines including egg and chicken proteins
2. History of laboratory confirmed or suspected typhoid fever in the past 3 years
3. History of laboratory confirmed or suspected yellow fever in the past
4. Fever of any origin or infectious disorder of 3 days or more within the past month
5. Febrile illness (body temperature ≥37.5°C) at the time of enrollment
6. Subjects positive for serological markers against Dengue infection(NS1 antigen, IgM and IgG antibodies)
7. History of any vaccination 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
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Non-inferiority for seroconversion for anti-Vi and anti-YF IgG antibodies at 28 days after vaccination
At 28 days after respective vaccination
Secondary Outcome
Outcome
TimePoints
Immunogenicity-Geometric mean titre of anti-Vi and anti-YF IgG antibodies at 28 days after vaccination
At 28 days after respective vaccination
Safety- Solicited local and systemic adverse events & Unsolicited adverse events reported during the study
Throughout the study duration
Safety-Serious adverse events reported during the study
Throughout the study duration
Target Sample Size
Total Sample Size="714" Sample Size from India="714" Final Enrollment numbers achieved (Total)= "715" Final Enrollment numbers achieved (India)="715"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a prospective, randomized, parallel, three-arm, open-label, multicenter, phase IV clinical trial to evaluate the immunological non-interference of Typhoid Vi conjugate vaccine with Yellow fever vaccine administered to healthy subjects. A total of 714 healthy subjects will be enrolled in the study with 1:1:1 allocation in the study groups (Test – 238; Reference 1 – 238; Reference 2 – 238).
The subjects will be enrolled in 4 age cohorts as follows: 9 months to <5 years; ≥5 to <12 years; ≥12 to <18 years and ≥18 to 65 years. A minimum of 40 subjects will be enrolled in each of the 4 age cohorts in each of the 3 study groups.
1. TCV+YF: Test Group: TCV and YF vaccine administered concomitantly after randomization of the subjects into the study at day 0.
2. TCV: Reference Group 1: TCV vaccine administered after randomization of the subjects into the study at day 0.
3. YF: Reference Group 2: YF vaccine administered after randomization of the subjects into the study at day 0.
Outcome of the study are; 1. Non-inferiority for seroconversion for anti-Vi and anti-YF IgG antibodies at 28 days after vaccination. 2. Immune response; Geometric mean titre of anti-Vi and anti-YF IgG antibodies at 28 days after vaccination. 3. Safety; Solicited local and systemic adverse events & Unsolicited adverse events reported during the study. 4. Safety: Serious adverse events reported during the study.