CTRI/2024/11/077184 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On:
22/09/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A Clinical trial to evaluate immune response and safety of Measles and Rubella vaccine manufactured by Zydus Lifesciences Ltd. as compared to marketed Measles and Rubella vaccine manufactured by Serum Institute of India Pvt.Ltd. in healthy infants aged 9-12 months.
Scientific Title of Study
A prospective, randomized, parallel, single-blind,four-arm, active-controlled, multicentre, phase IV clinical trial to evaluate immunogenicity and safety of MR vaccine of M/s. Zydus Lifesciences Ltd. vs. MR vaccine of M/s. Serum Institute of India Pvt.Ltd. and to evaluate lot-to-lot consistency of MR vaccine of M/s. Zydus Lifesciences Ltd. in healthy infants aged 9-12 months.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
24-02, Version 00, dated 09/03/2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pavankumar Daultani
Designation
Deputy General Manager
Affiliation
Zydus Lifesciences Ltd
Address
Zydus Corporate Park,
Scheme No. 63, Survey No. 536,
Khoraj (Gandhinagar), Nr. Vaishnodevi Circle,
S.G. Highway
Ahmadabad GUJARAT 382481 India
Phone
07948040000
Fax
Email
pavankumar.daultani@zyduslife.com
Details of Contact Person Scientific Query
Name
Dr Pavankumar Daultani
Designation
Deputy General Manager
Affiliation
Zydus Lifesciences Ltd
Address
Zydus Corporate Park,
Scheme No. 63, Survey No. 536,
Khoraj (Gandhinagar), Nr. Vaishnodevi Circle,
S.G. Highway
GUJARAT 382481 India
Phone
07948040000
Fax
Email
pavankumar.daultani@zyduslife.com
Details of Contact Person Public Query
Name
Dr Pavankumar Daultani
Designation
Deputy General Manager
Affiliation
Zydus Lifesciences Ltd
Address
Zydus Corporate Park,
Scheme No. 63, Survey No. 536,
Khoraj (Gandhinagar), Nr. Vaishnodevi Circle,
S.G. Highway
GUJARAT 382481 India
Phone
07948040000
Fax
Email
pavankumar.daultani@zyduslife.com
Source of Monetary or Material Support
Zydus Lifesciences Limited
(formerly known as Cadila Healthcare Ltd.)
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 Ltd
Address
Scheme No. 63, Survey No. 536,
Khoraj (Gandhinagar), Nr. Vaishnodevi Circle,
S.G. Highway, Ahmedabad – 382481,
Gujarat, India
Health 1 Super Speciality Hospital Ethics Committee,Health 1 Super Speciality Hospital, S.P. Ring road, Near Shilaj Circle, Shilaj, Ahmedabad - 380059, Gujarat
Approved
Institutional Ethics Committee, Belagavi Institute of Medical Sciences,Dr B.R. Ambedkar Road, Sadashiv Nagar, Belagavi –590001, Karnataka
Approved
Institutional 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 Main Road, Bopal, Ahmedabad-380058, Gujarat
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, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar-751019, Odisha, India.
Approved
Institutional Ethics Committee, Hi-Tech Medical College & Hospital, Health Park, Pandara, Rasulgarh, Bhubaneswar –751025, Odisha
Approved
Institutional Ethics Committee, Institute of Medical Science (IMS) & Sum Hospital, K-8, Kalingnagar, Shampur,Bhubaneswar, Khordha - 751003 Odisha
Approved
Institutional Ethics Committee, KLE University, KLES Dr. Prabhakar Kore Hospital & Medical Research Centre, Nehrunagar, Belagavi 590010, Karnataka
Approved
Institutional Ethics Committee, Osmania Medical College, Koti, Hyderabad-500059, Telangana.
Institutional Ethics Committee, Sumandeep Vidyapeeth At & Post Pipariya Vadodara Gujarat 391760 India
Approved
Institutional Ethics Committee, Zydus Medical College and Hospital, Dahod Civil Hospital, Opp. Nehru Baug, Station Road Dahod-389151, Gujarat – 389151, India
Approved
Prakash Medical College Institutional Ethics Committee, Prakash Institute of Medical Science and Research Sangli Road Urun Islampur Walwa Sangli Maharashtra-415409 India
Approved
Sant Dnyaneshwar Medical Education Research Centre Institutional Ethics Committee,695 A Sadashiv Peth, Laxmi Road, Opp Vijay Talkies, Pune,India
Supreme Independent Ethics Committee, 1856, Bhekarai Nagar, Opposite to IBM Company Fursungi, Haveli, Pune-412308
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
Comparator Agent
Measles and Rubella vaccine (Live)
I.P. (Freeze Dried) of M/s. Serum Institute of India
Pvt. Ltd.
Dose:- 0.5 ml
Route:-subcutaneous injection
Frequency :single dose
Intervention
Measles and Rubella vaccine (Live) I.P.
(Freeze Dried) of M/s. Zydus Lifesciences Ltd.
Dose:- 0.5 ml
Route:-subcutaneous injection
Frequency :single dose
Duration: Single Dose
Inclusion Criteria
Age From
9.00 Month(s)
Age To
12.00 Month(s)
Gender
Both
Details
1. Healthy infant subject of either sex aged 9 to 12 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 previous history of vaccination against 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
6. Subjects and parents likely to be available for follow-up for entire duration of
the study
ExclusionCriteria
Details
1. History of hypersensitivity reaction to any component of the vaccines
2. History of hypersensitivity reaction to neomycin
3. History of laboratory confirmed or suspected measles or rubella in past
4. History of any vaccination against measles or rubella in past
5. Subject exposed to measles or rubella virus within the past 30 days
6. Fever of any origin or infectious disorder of 3 days or more within the past 30
days
7. Febrile illness (axillary temperature ≥37.5°C) at the time of enrollment
8. History of any vaccination within the past month
9. Clinically significant systemic disorder such as cardiovascular, respiratory,
neurologic, gastrointestinal, hepatic, renal, endocrine, hematological,
immunological, metabolic or major congenital disorder
10. Confirmed or suspected immunosuppressive or immunodeficiency disorder;
or subjects on any immunosuppressive or immunostimulant therapy
11. Known case of thrombocytopenia or any coagulation disorder, or subjects on
anticoagulation therapy
12. Subjects administered blood, blood containing products or immunoglobulins
within the last 3 months or planned administration during the study
13. Subject participated in another clinical study in the past 3 months
14. Any other reason for which the investigator feels that subject should not
participate
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Other
Blinding/Masking
Participant Blinded
Primary Outcome
Outcome
TimePoints
1)Non-inferiority for seropositivity rate for anti-measles and anti-rubella IgG
antibodies at 42 days after vaccination between the test group and the
reference group
2)Lot-to-lot consistency of 3 batches of the test vaccine at 42 days after
vaccination based on geometric mean titre ratio
Baseline (Day 0) and Day 42
Secondary Outcome
Outcome
TimePoints
Seropositivity rate for anti-measles and anti-rubella IgG antibodies
Baseline (Day 0) and End of study (Day 180)
Seroconversion rate for anti-measles and anti-rubella IgG antibodies
Baseline (Day 0), Day 42 and End of study (Day 180)
Geometric mean titre of anti-measles and anti-rubella IgG antibodies
Baseline (Day 0), Day 42 and End of study (Day 180)
Solicited local and systemic adverse events
Baseline (Day 0) to Day 14
Unsolicited adverse events
Baseline (Day 0) to End of study (Day 180)
Medically attended adverse events
Baseline (Day 0) to End of study (Day 180)
Serious adverse events
Baseline (Day 0) to End of study (Day 180)
Target Sample Size
Total Sample Size="2428" Sample Size from India="2428" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This will be a randomized, multicentre study in which the subjects would be administered a single dose of either MR vaccine M/s. Zydus Lifesciences Ltd. (test vaccine) or MR vaccine of M/s. Serum Institute of India Pvt. Ltd. (reference vaccine) at enrollment and then the subjects will be followed up for 6 months immunogenicity and safety evaluation. To evaluate lot-to-lot consistency of the test vaccine, 3 different batches of the vaccine will be used in the study. Anti-measles and anti-rubella IgG antibodies will be assessed from the samples collected prior to vaccination and 42 days & 180 days after vaccination using commercially available ELISA kits at the central laboratory.