CTRI/2021/11/037996 [Registered on: 12/11/2021] Trial Registered Prospectively
Last Modified On:
16/09/2022
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Vaccine
Study Design
Single Arm Study
Public Title of Study
A post-marketing surveillance study to evaluate the safety and immunological response of typhoid conjugate vaccine in healthy subjects
Scientific Title of Study
An active post-marketing surveillance study to evaluate the safety and immunogenicity of ZyVac TCV of M/s. Cadila Healthcare Limited in healthy subjects
Trial Acronym
NA
Secondary IDs if Any
Secondary ID
Identifier
21-09; Version No. 00; Dated 20/08/2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Ravindra Mittal
Designation
Medical Advisor & Head - Regulatory Affairs
Affiliation
Cadila Healthcare Limited
Address
Cadila Healthcare Ltd. Zydus Corporate Park, Scheme No. 63,
Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G.
Highway, Ahmedabad – 382481, Gujarat, India
Ahmadabad GUJARAT 382481 India
Phone
Fax
Email
r.mittal@zyduscadila.com
Details of Contact Person Scientific Query
Name
Dr Ravindra Mittal
Designation
Medical Advisor & Head - Regulatory Affairs
Affiliation
Cadila Healthcare Limited
Address
Cadila Healthcare Ltd. Zydus Corporate Park, Scheme No. 63,
Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G.
Highway, Ahmedabad – 382481, Gujarat, India
Basement, Research
Room, Aatman
Hospital, 5, Anveshan
Row House, Opp
Umiya Mata Mandir,
Bopal-Ghuma Road,
Bopal, Ahmedabad -
380058 Ahmadabad GUJARAT
9825182251
cr.aatman@gmail.com
Dr Lisa Sarangi
Hi-Tech Hospital
Department of Community Medicine, Hi-Tech Medical College & Hospital, Health Park, Pandra, Rasulgarh, Bhubaneswar – 751025, Odisha Khordha ORISSA
9437165488
sarangilisa@gmail.com
Dr Monjori Mitra
Institute of Child Health
Ground floor, Institute of Child Health, 11, Dr. Biresh Guha Street, Kolkata - 700017, West Bengal Kolkata WEST BENGAL
9031075734
monjorimr@gmail.com
Dr Dillip Kumar Dash
Institute of Medical Sciences & SUM Hospital
Department of Pediatrics, Institute of Medical Science & SUM Hospital, K8, Kalinga Nagar, Ghatikia, Bhubaneswar-751003, Odisha Khordha ORISSA
9437167337
drdillipdash10.10@gmail.com
Dr Jai Prakash Narayan
Jawahar Lal Nehru (JLN) Hospital
Basement, Research
Department, Department of Pediatrics, Jawahar Lal Nehru Medical College & Hospital, Kala Bagh, Ajmer – 305001, Rajasthan Ajmer RAJASTHAN
9314294402
narayan_jaiprakash@yahoo.co.in
Dr Abhishek Chavan
Jeevan Rekha Hospital
Clinical Research
Department, Second
Floor, Jeevan Rekha
Hospital, Dr. B.R.
Ambedkar Road Opp
Civil Hospital Belagavi Belgaum KARNATAKA
Department of Pediatrics, Mahatama Gandhi Medical College and Hospital, RIICO Institutional Area, Tonk Road, Sitapura, Jaipur - 302022, Rajasthan Jaipur RAJASTHAN
9314711100
mkkakkar15@gmail.com
Dr Sanjay Vasant Mankar
Mankar Hospital
Mankar Hospital, Swaroop Housing Society,
Plot No 19,Narveer Tanaji Malusare Road,
Anandnagar, Pune, Maharashtra 411051
Pune MAHARASHTRA
9970126406
drmankarsanjay.pulse@gmail.com
Dr N Ravi Kumar
Niloufer Hospital
Room No. 18, 1st Floor, Department of Pediatrics, Niloufer Hospital (Affiliated to Osmania Medical College), Red Hills, Baazar Ghat, Lakdikapool, Hyderabad-500004, Telangana Hyderabad TELANGANA
Anand Institutional Ethics Committee Anand Multispeciality Hospital, Beside IOCL Petrol Pump Near Gorwa ITI Vadodara - 390016
Approved
Ethics Committee, Institute of Child Health, 11, Dr. Biresh Guha Street, Kolkata – 700017, West Bengal
Approved
Institutional Ethics Committee, Aatman Hospital, 5, Anveshan Row House, Opp Umiya Mata Mandir, Bopal-Ghuma Road, Bopal, Ahmedabad - 380058, Gujarat
Approved
Institutional Ethics Committee, Hi-Tech MCH, Hi-Tech Medical College and Hospital Health Park Pandara, Ra§ulgarh, Bhubane§war Khordha. Orissa -751025
Typhoid Vi Conjugate Vaccine I.P. of
M/s. Cadila Healthcare Ltd. (ZyVac
TCV)
subject will receive a single dose of 0.5 ml of ZyVac TCV. The vaccine will
be administered as intramuscular injection in upper arm or anterolateral aspect of
upper thigh (for younger children 2 years of age) taking aseptic precautions
Inclusion Criteria
Age From
6.00 Month(s)
Age To
45.00 Year(s)
Gender
Both
Details
1. Healthy subjects of either gender ≥6 months to ≤45 years of age at the time of enrollment
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
4. Informed consent from the adult subjects or from the parents of pediatric subjects. Additionally, assent from pediatric subjects aged 7 years or more
5. Adult subjects or parents of pediatric subjects literate enough to fill the diary card
6. Adult subjects or, pediatric subjects and their parents intend to be available
for follow-up for entire duration of the study
ExclusionCriteria
Details
1. History of hypersensitivity reaction to any component of the vaccine
2. History of laboratory confirmed or suspected typhoid fever in the past 3 years
3. Subject who have had household contact with/ and/or intimate exposure to an individual with laboratory confirmed S. typhi
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. History of any vaccination within the past month
7. History of COVID-19 within the past 3 months
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 or subject intend to participate in another clinical study within 3 months following
intended study vaccine administration
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
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Adverse events reported
Throughout the study duration
Secondary Outcome
Outcome
TimePoints
Seroconversion rate
28 days after vaccination
Geometric mean titre of anti-Vi IgG antibodies
Baseline (pre-vaccination) and 28 days after vaccination
Target Sample Size
Total Sample Size="3000" Sample Size from India="3000" Final Enrollment numbers achieved (Total)= "3037" Final Enrollment numbers achieved (India)="3037"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is an active post-marketing surveillance (PMS) study to evaluate the safety and immunogenicity of ZyVac TCV of M/s. Cadila Healthcare Limited in healthy subjects. A total of 3000 healthy subjects of 6 months to 45 years age group will be enrolled in this PMS study. The primary objective is to evaluate safety of the vaccine which will be assessed by recording adverse events throughout the study duration. The secondary objective is to evaluate the immunogenicity of the vaccine in a subset of overall population. For immunogenicity, seroconversion (at least 4-fold rise in anti-Vi IgG antibody titre 28 days after vaccination) and geometric mean titre of anti-Vi IgG antibodies at the baseline and at 28 days after vaccination will be evaluated.