| CTRI Number |
CTRI/2024/11/077318 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2025 |
| 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 study to check the immunogenicity and safety of two doses of SII-MMR vaccine in healthy infants in India |
|
Scientific Title of Study
|
A phase IV, double blind, randomized, active control clinical study
comparing safety and immunogenicity of SII-Measles-Mumps-
Rubella vaccine with PRIORIX (GSK) in healthy infants in India |
| Trial Acronym |
MMR01/23 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MMR 01/ 23 Version 2 dt 17 Apr 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prasad Kulkarni |
| Designation |
Executive director |
| Affiliation |
Serum Institute of India Pvt Ltd. Pune India |
| Address |
212 2 Off Soli Poonawalla road Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
02071946820 |
| Fax |
|
| Email |
drpsk@seruminstitute.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasad Kulkarni |
| Designation |
Executive director |
| Affiliation |
Serum Institute of India Pvt Ltd. Pune India |
| Address |
212 2 Off Soli Poonawalla road Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
02071946820 |
| Fax |
|
| Email |
drpsk@seruminstitute.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasad Kulkarni |
| Designation |
Executive director |
| Affiliation |
Serum Institute of India Pvt Ltd. Pune India |
| Address |
212 2 Off Soli Poonawalla road Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
02071946820 |
| Fax |
|
| Email |
drpsk@seruminstitute.com |
|
|
Source of Monetary or Material Support
|
| Serum Institute of India Pvt Ltd
212 2 Off soli Poonawalla Road Hadapsar Pune |
|
|
Primary Sponsor
|
| Name |
Serum institute of India Pvt Ltd Pune |
| Address |
212, Off Soli Poonawalla road Hadapsar Pune - 411028 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepshikha Kamra |
Christian Medical College & Hospital |
Department of Community Medicine, first floor, Christian Medical College, and Hospital. Brown Road Ludhiana, Punjab - 141008
Ludhiana
PUNJAB |
9463034958
deepshikhakamra@gmail.com |
| Dr Afreen Khan |
Hamdard Institute of Medical Science and Research |
Clinical Research Center HIMSR with Society for Applied Studies, B- block basement,
Hakeem Abdul Hameed Centenary Hospital (HAHCH),
Guru Ravidas Marg, Hamdard Nagar, New Delhi-110062
New Delhi
DELHI |
7503857784
drafreen.himsr@gmail.com |
| Dr Kheya Ghosh |
Institute of Child Health |
11, Dr. Biresh Guha Street, Park Circus, Kolkata-700017
Kolkata
WEST BENGAL |
9830297578
kheya.ghosh.uttam@gmail.com |
| Dr Sushma K |
JSS Hospital |
NICU department of Pediatrics, first floor,
Mahatma Gandhi Road, Fort Mohalla, Mysuru, Karnataka 570004
Mysore
KARNATAKA |
9742299896
drsushmasri@gmail.com |
| Dr Sonali Kar |
Kalinga Institute of Medical Sciences (KIMS) |
Child Welfare and Immunization,
1st Floor, Dept of Pead.& Gynec, Near Immunization centre,
Kalinga Institute of Medical Sciences (KIMS),
KIIT Deemed University, Kushabhadra Campus-5, KIIT Road,
Bhubaneswar, Odisha
PIN-751024
Khordha
ORISSA |
9438423273
sonsam72@yahoo.co.uk |
| Dr Anand Kawade |
KEM Hospital Research Centre Vadu Rural Health Program |
Vadu Rural Health Program, At post Vadu Budruk, Taluka Shirur District Pune 412216
Pune
MAHARASHTRA |
9850559983
anand.kawade@kemhrcvadu.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Christian Medical College & Hospital |
Approved |
| Institutional Ethics Committee HIMSR and associated HAH Centenary Hospital |
Approved |
| Institutional Ethics Committee ICH Institute of Child Health |
Approved |
| Institutional Ethics Committee, JSS Medical College JSS Hospital |
Approved |
| KEM Hospital Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PRIORIX |
Priorix is a live attenuated vaccine. It is a lyophilized mixed preparation of the attenuated Schwarz measles, RIT 4385 mumps (derived from Jeryl Lynn strain) and Wistar RA 27/3 rubella strains of viruses, separately obtained by propagation either in chick embryo tissue cultures (mumps and measles) or MRC-5 human diploid cells (rubella).
Dose 0.5 ml, Frequency- 2 doses 6 months apart, Route of administration - subcutaneous |
| Intervention |
SII MMR vaccine |
SII-MMR vaccine is a live
attenuated and is prepared from live attenuated strains of Edmonston-
Zagreb Measles virus propagated on human diploid cell culture,
Leningrad-Zagreb Mumps virus propagated on chick embryo
fibroblast cells and Wistar RA 27/3 Rubella virus propagated on
human diploid cell culture.
Dose 0.5 ml, Frequency- 2 doses 6 months apart, route of administration - subcutaneous |
|
|
Inclusion Criteria
|
| Age From |
9.00 Month(s) |
| Age To |
11.00 Month(s) |
| Gender |
Both |
| Details |
1) Healthy male and female infants between 9 months and 11 months old
2) Parent of study participant willing to give written informed consent.
3) Free of obvious health problems as established by medical history and screening evaluation including clinical examination. |
|
| ExclusionCriteria |
| Details |
1. Acute illness
2. Congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy
3. History of allergy or systemic hypersensitivity to any of the vaccine component or to a vaccine containing the same substances
4. Acute or chronic, clinically significant systemic disorder/disease
5. History of measles, mumps, or rubella infection
6. Previous history of Measles/Rubella/MR/MMR vaccination.
7. History of allergy to eggs, milk, neomycin or gelatin. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of study participants with seropositivity for measles, mumps and rubella |
41 days after the second dose of the study vaccine |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Geometric Mean titers (GMT) for anti-measles, anti-mumps and anti-rubella antibodies mumps and rubella 41 and 179 days after the first dose of the study vaccine |
At 41 and 179 days after the first dose, and 41 days after the second dose of study vaccine
|
| Proportion of study participants with seropositivity for measles, mumps and rubella |
41 and 179 days after the first dose of study vaccine |
| Proportion of study participants with seroconversion for measles, mumps and rubella |
At 41 and 179 days after the first dose, and 41 days after the second dose of study vaccine |
Proportion of study participants with seroresponse for measles,
mumps and rubella |
At 41 and 179 days after the first dose, and 41 days after the second dose of study vaccine |
| Solicited adverse events |
through 14 days following each dose of the study vaccine. |
| Unsolicited adverse events |
through 41 days following each dose of the study vaccine |
| Serious adverse events |
Throughout study participation |
|
|
Target Sample Size
|
Total Sample Size="429"
Sample Size from India="429"
Final Enrollment numbers achieved (Total)= "429"
Final Enrollment numbers achieved (India)="429" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
06/01/2025 |
| Date of Study Completion (India) |
11/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is a randomized, double blind, active control, multi-center clinical study to evaluate and compare immunogenicity and safety of two doses of SII-MMR vaccine with two doses of Priorix in 429 healthy Indian infants. |