CTRI/2025/06/089085 [Registered on: 18/06/2025] Trial Registered Prospectively
Last Modified On:
05/09/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine
Study Design
Other
Public Title of Study
Study to examine immune response and safety of Zyvac® MMR vaccine
Scientific Title of Study
A prospective, randomized, parallel, single-blind, two-arm, active-controlled, multicentre, phase IV clinical trial to evaluate the immunogenicity and safety of Measles, Mumps, and Rubella vaccine (Live) I.P. (Freeze Dried) of M/s. Zydus Lifesciences Ltd. compared to Measles, Mumps, and Rubella vaccine (Live) I.P. (Freeze Dried) of M/s. Serum Institute of India Pvt. Ltd. in healthy infants aged 9-12 months
Department of Community Medicine and Family Medicine, Sijua, Patrapada, Bhubaneswar - 751019, Odisha Khordha ORISSA
9438884019
cmfm_swayam@aiimsbhubaneswar.edu.in
Dr Neeta Hanumante
Bharati Vidyapeeth Medical College Hospital and Research Center
Pune - Satara Road, Katraj Dhankawadi, Pune – 411043, Maharashtra, India Pune MAHARASHTRA
9822031387
neeta.hanumante@gmail.com
Dr Bakul Javadekar
Dhiraj Hospital
Dhiraj Hospital, SBKS MI & RC, Sumandeep Vidyapeeth Deemed to be University, At & Po. Piparia, Ta. Waghodia, Vadodara 391760, Gujarat, India Vadodara GUJARAT
9925014448
dean.medical@sumandeepvidyapeethdu.edu.in
Dr Neha Thakur Rai
Dr. Ram Manohar Lohia Institute of Medical Sciences
Ram Prakash Gupta Mother & Child state Referral Hospital, Amar Shaheed Path, Near Dial 100 Police office, Gomti Nagar, Lucknow, Ardonamau, Uttar Pradesh - 226002, India Lucknow UTTAR PRADESH
7607804654
nehaimsbhu@gmail.com
Dr Nehal Patel
GMERS Medical College and Civil Hospital
Department of Pediatrics, Near Gujarat High Court, S.G. Highway, Sola, Ahmedabad - 380060, Gujarat Ahmadabad GUJARAT
7567897517
nehal_pedia@yahoo.com
Dr Jyotsana Seepana
Government Medical College and Government General Hospital
Department of Pediatrics, OPD No: 14, 1st floor, Srikakulam - 532001, Andhra Pradesh, India
Srikakulam ANDHRA PRADESH
9966612126
drjyotsnaggh@yahoo.com
Dr Jai Prakash Narayan
Jawahar Lal Nehru Medical College
Kala Bagh, Ajmer, Rajasthan – 305001, India Ajmer RAJASTHAN
KLES Dr Prabhakar Kore Hospital & Medical Research Centre
Nehrunagar, Belagavi - 590010, Karnataka, India Belgaum KARNATAKA
9483561674
drmahantesh@gmail.com
Dr Anilkumar Dinkar Bhoi
Krishna Vishwa Vidyapeeth (Deemed to be University)
Dept. of Pediatrics, Krishna Charitable hospital and research Centre, Karad, Pune - Bangalore highway - 4, near Dhebewadi, Phata, Malkapur road, Karad, Maharashtra - 415539 Satara MAHARASHTRA
9975882496
dranilbhoi@yahoo.com
Dr Yashwant Kumar Rao
LLR Hospital
Department of Pediatrics, GSVM Medical College, Swaroop Nagar, Kanpur - 208002, Uttar Pradesh.
Kanpur Nagar UTTAR PRADESH
Karnataka Institute of Medical Sciences Ethics Committee
Approved
Leelavati Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
For active immunization against Measles, Mumps & Rubella
Intervention / Comparator Agent
Type
Name
Details
Intervention
Measles, Mumps and Rubella vaccine (Live) I.P. (Freeze Dried) of M/s. Zydus Lifesciences Ltd.
Dose: 0.5 ml
Duration: 180 days
Frequency of administration: Two times
Comparator Agent
Measles, Mumps, and Rubella vaccine (Live) I.P. (Freeze Dried) of M/s. Serum Institute of India Pvt. Ltd.
Dose: 0.5 ml
Duration: 180 days
Frequency of administration: Two times
Inclusion Criteria
Age From
9.00 Month(s)
Age To
12.00 Month(s)
Gender
Both
Details
1. Healthy infant participant of either gender aged 9 to 12 months at the time of enrollment
2. Participants 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, mumps and rubella
4. Written informed consent from the subjects parent (mother/father)
5. Participants parent literate enough to fill the diary card
6. Participants and parents likely to be available for follow-up for entire duration of the study
Age calculated as per completed months
ExclusionCriteria
Details
1. History of hypersensitivity reaction to any component of the vaccines
2. History of hypersensitivity reaction to neomycin, gelatin or albumin
3. History of hypersensitivity to egg proteins.
4. History of laboratory confirmed or suspected measles, mumps or rubella in past
5. Subject exposed to measles, mumps 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 greater than or equals to 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. Participants administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
13. Subject participated in any clinical study in the past 3 months
14. Any other reason for which the investigator feels that subject should not participate
Close contact (family member or neighbour) with laboratory confirmed or clinical diagnosis of measles / mumps / rubella
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant Blinded
Primary Outcome
Outcome
TimePoints
To evaluate the immunogenicity of MMR vaccine of M/s. Zydus Lifesciences Ltd. compared to MMR vaccine of M/s. Serum Institute of India Pvt. Ltd. in healthy infants aged 9-12 months
At Day 0, weeks 6, weeks 26, weeks 32
Secondary Outcome
Outcome
TimePoints
To evaluate the safety of MMR vaccine of M/s. Zydus Lifesciences Ltd. compared to MMR vaccine of M/s. Serum Institute of India Pvt. Ltd. in healthy infants aged 9-12 months
At Day 0, weeks 2, weeks 6, weeks 26, weeks 28, weeks 32
Target Sample Size
Total Sample Size="720" Sample Size from India="720" 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 4
Date of First Enrollment (India)
01/07/2025
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="0" Months="8" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
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
This will be
a prospective, randomized, two-arm, single-blind, parallel, non-inferiority,
multicentre phase IV clinical study planned to evaluate the immunogenicity and
safety of MMR vaccine of M/s. Zydus Lifesciences Ltd. and compare it with the
WHO prequalified MMR vaccine of M/s. Serum Institute of India Pvt. Ltd.
Participants
evaluated as per the inclusion and exclusion criteria and should be in good
health as determined by medical history and physical examination based on
clinical judgment of the investigator. The participant should not have previous
history of vaccination against measles, mumps and rubella.
Participant will be randomized in one
of the 2 study groups as per their allocated randomization number and will be
administered the allocated study vaccine during visit 1 / day 0 and visit 4 /
day 180 in a single-blinded manner.
Healthy
infants aged 9-12 months will be enrolled in this trial. Both the study
vaccines will be available in single dose presentation in lyophilized form. The
vaccine will be reconstituted with the diluent supplied along with the vaccine
immediately prior to vaccination. The enrolled participants will be
administered 2 doses of MMR vaccine at an interval of 180 days.
Participants’
parents will be asked to visit follow-up of participant on day 14 (visit 2),
day 42 (visit 3), day 180 (visit 4), day 194 (visit 5), and day 222 (visit 6).
They will be observed for at least 30 minutes post vaccination after each dose
at respective visits.
Blood sample
of (3 ml) each will be collected prior to vaccination at day 0 (visit 1), day
42 (visit 3), prior to vaccination at day 180 (visit 4) and day 222 (visit 6)
for immuno-logical assessment.
Diaries will
be provided to the enrolled participants parents to record local (injections
site) and systemic AEs that may occur after vaccination. One diary card will be
pro-vided after each vaccination. Solicited local AEs (pain, redness, swelling
& induration) will be recorded for 7 days after vaccination; solicited
systemic AEs (fever, rashes, running nose, cough, cold, diarrhea, vomiting,
abnormal crying, loss of appetite, drowsiness & irritability) will be
recorded for 14 days after vaccination and unsolicited (other) AEs will be
recorded for 42 days after vaccination. The diary card will be collected during
follow-up visit 42 days after vaccination.
All unsolicited AEs occurring within 42 days
post-vaccination will be recorded. After 42 days of first vaccination,
unsolicited AEs will only be recorded if they are defined as serious adverse
events (SAEs) or medically attended adverse events (MAAEs).