CTRI/2022/02/040274 [Registered on: 14/02/2022] Trial Registered Prospectively
Last Modified On:
18/04/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
A clinical study to evaluate non-interference of immune response generated by Typhoid conjugate vaccine and Measles and Rubella vaccine administered to healthy infants
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 Measles and Rubella vaccine administered to healthy infants
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
20-03 (Protocol Version No. 00; Dated 17/03/202)
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
Baramati Hospital Private Ltd., Behind Kavivarya, Moropant Natyamandir, Ring Road, Baramati Pune MAHARASHTRA
9822402772
jedhedeshmukh.12@gmail.com
Dr Neeta Hanumante
Bharati Hospital and Research Centre
Bharati Vidyapeeth (Deemed to be University) Medical College & Hospital, Katraj- Dhankawadi, Pune-Satara Road, Pune Pune MAHARASHTRA
020-24364308
researchpedpune@gmail.com
Dr Mohammed Moonis Akbar Faridi
Eras Lucknow Medical College & Hospital
1st Floor, Department of Pediatrics, Eras Lucknow Medical College & Hospital, Sarfaraz Ganj Hardoi road Lucknow 226003 Lucknow UTTAR PRADESH
7317794765
mmafaridi@yahoo.co.in
Dr Lisa Sarangi
Hi-Tech Hospital
1st Floor, Professor Room, Department of Community Medicine, Hi-Tech Medical College & Hospital, Health Park, Pandra, Rasulgarh, Bhubaneswar – 751025 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 B Ramesh Kumar
King George Hospital
Department of Pediatrics, King George Hospital, Maharanipeta , Visakhapatnam Visakhapatnam ANDHRA PRADESH
9248863180
ramesh.kghamc@gmail.com
Dr Nishant Verma
King George’s Medical University
5th Floor, Kalam center,
Department of
Pediatrics, King
George’s Medical
University, Shahmeena
Road, Chowk,
Lucknow-226003, Uttar
Pradesh
Lucknow
UTTAR PRADESH Lucknow UTTAR PRADESH
8765806252
drnishantaiims@gmail.com
Dr Mahantesh Patil
KLES Dr. Prabhakar Kore Hospital and Medical Research Centre
Department of Pediatrics, KLES Dr. Prabhakar Kore Hospital & Medical Research Centre, Nehrunagar, Belagavi Belgaum KARNATAKA
9483561674
drmahantesh@gmail.com
Dr Girish Nanoti
Lata Mangeshkar Hospital
Department of Pediatrics, Lata Mangeshkar Hospital, Digdoh Hills, Hingna, Nagpur Nagpur MAHARASHTRA
9422492050
gir655uv@yahoo.co.in
Dr Sanjay Vasant Mankar
Mankar Hospital
Ground Floor, Mankar Hospital, Swaroop Housing Society, Plot No 19,Narveer Tanaji Malusare Road, Anandnagar, Pune Pune MAHARASHTRA
9970126406
drmankarsanjay.pulse@gmail.com
Dr G Preeti
Niloufer Hospital
Room No. 18, 1st Floor, Niloufer Hospital (Affiliated to Osmania Medical College), Red Hills, Baazar Ghat, Lakdikapool, Hyderabad Hyderabad TELANGANA
9842410324
drpreetinagaraj@gmail.com
Dr Deepali Ambike
Yashwantrao Chavan Memorial Hospital
Department of Paediatrics, Post-graduate Institute, Yashwantrao Chavan Memorial Hospital, Sant Tukaram Nagar, Pimpri, Pimpri-Chinchwad, Pune-411018 Pune MAHARASHTRA
Institutional Ethics Committee, Yashwantrao Chavan Memorial Hospital, Sant Tukaram Nagar, Pimpri, Pune - 411018, Maharashtra
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Active immunization against Typhoid, Measles and
Rubella
Intervention / Comparator Agent
Type
Name
Details
Intervention
1. Typhoid Vi Conjugate Vaccine I.P. of M/s. Cadila Healthcare Limited [TCV]
2. Measles and Rubella Vaccine (Live), I.P. (Freeze Dried) of M/s. Cadila Healthcare Limited [MR vaccine]
1. Subjects will receive a single dose (0.5 ml) of TCV administered as an intramuscular injection in anterolateral aspect of the upper thigh taking care of aseptic precautions.
2. Subjects will receive a single dose (0.5 ml) of MR vaccine as a subcutaneous injection in anterolateral aspect of upper thigh taking care of aseptic precautions.
In the test group, both TCV and MR vaccine will be administered concomitantly as separate injections in different thighs.
In Reference group 1 (MR/TCV): MR vaccine administered at day 0 followed by TCV at
day 28.
In Reference group 2 (TCV/MR): TCV administered at day 0 followed by MR vaccine at
day 28
Comparator Agent
Not applicable
Not applicable
Inclusion Criteria
Age From
9.00 Month(s)
Age To
10.00 Month(s)
Gender
Both
Details
1. Healthy infant subject of either gender aged (Age calculated as per completed months) 9 to 10 months at the time of enrollment
2. Subjects should be in good health as determined by medical history and physical examination based on clinical judgment of the investigator
3. No history of vaccination against typhoid fever, measles and rubella
4. Written informed consent from the subject’s parent (mother/father)
5. Subject’s parent literate enough to fill the diary card
ExclusionCriteria
Details
1. History of hypersensitivity reaction to any component of the vaccines
2. History of laboratory confirmed or suspected measles, rubella or typhoid fever in past
3. History of any vaccination against typhoid fever, measles or rubella in past
4. Subject exposed (Close contact (family member or neighbour) with laboratory confirmed or clinical diagnosis
of measles / rubella / typhoid fever) to measles virus, rubella virus or Salmonella typhi within the past 30 days
5. Fever of any origin or infectious disorder of 3 days or more within the past 30 days
6. Febrile illness (axillary temperature ≥ 37.5°C) at the time of enrollment
7. History of any vaccination within the past 30 days
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. Subject participated in another clinical study in the past 3 months
13. 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, anti-measles and anti-rubella IgG
antibodies
At 28 days after respective vaccination
Secondary Outcome
Outcome
TimePoints
Geometric mean titre of anti-Vi, anti-measles and anti-rubella IgG antibodies
At 28 days after respective vaccination
Seroconversion rate and geometric mean titre of anti-Vi, anti-measles and antirubella
IgG antibodies
At the end of the study
Adverse events reported
Throughout the study duration
Target Sample Size
Total Sample Size="900" Sample Size from India="900" Final Enrollment numbers achieved (Total)= "900" Final Enrollment numbers achieved (India)="900"
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 (TCV) with Measles and Rubella (MR) vaccine administered to healthy infants. A total of 900 healthy infants of 9 to 10 months age will be enrolled in this study. The primary objective is to evaluate the immunological non-interference of co-administration of TCV with MR vaccine. To evaluate the possible effect of co-administration of the vaccines on the immune response, both TCV with MR vaccine will be administered concomitantly in one set of subjects (test group) while in other set of subjects, these vaccines will be administered sequentially (reference groups). The study subjects will be allocated to one of the three study groups as mentioned below in 1:1:1 allocation ratio based on the central computer generated randomization plan.
1. Test group (TCV+MR): TCV and MR vaccine administered concomitantly at day 0
2. Reference group 1 (MR/TCV): MR vaccine administered at day 0 followed by TCV at day 28
3. Reference group 2 (TCV/MR): TCV administered at day 0 followed by MR vaccine at day 28
The immune response (seroconversion and geometric mean titre of antibodies) in the subjects who have been administered TCV and MR vaccine concomitantly will be compared with the immune response in the subjects who have been administered TCV and MR vaccine sequentially. The subjects will be followed up for 6 months after concomitant / last vaccination. The safety of the study vaccines will be assessed by recording the adverse events occurring during the entire course of the study.