CTRI/2025/11/097159 [Registered on: 11/11/2025] Trial Registered Prospectively
Last Modified On:
03/03/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine Biological Preventive
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical trial to assess the safety and protection of Biological Es Measles-Rubella Vaccine in 9-12 months old Infants in India.
Scientific Title of Study
A Phase II/III randomised, single blind, comparative, multicentre study to evaluate the safety and immunogenicity of Biological E’s live, attenuated Measles-Rubella vaccine (MR) in 9-12 months old healthy infants.
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
BECT076/MRV-Phase-II/III/CTP-02 Version :2.0 dated:07.05.25
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Subhash Thuluva
Designation
Sr. Vice President- Clinical Development
Affiliation
Biological E.Limited
Address
Clinical Development Dept, Room no:5,2nd floor, Road No.35,Jubilee Hills
Hyderabad TELANGANA 500033 India
Phone
04071216248
Fax
Email
subhash.thuluva@biologicale.com
Details of Contact Person Scientific Query
Name
Dr Subhash Thuluva
Designation
Sr. Vice President- Clinical Development
Affiliation
Biological E.Limited
Address
Clinical Development Dept, Room no:5,2nd floor, Road No.35,Jubilee Hills
TELANGANA 500033 India
Phone
04071216248
Fax
Email
subhash.thuluva@biologicale.com
Details of Contact Person Public Query
Name
Mr Subba Reddy GV
Designation
Associate Vice President- Clinical Development
Affiliation
Biological E.Limited
Address
Clinical Development Dept, Room no:3,2nd floor, Road No.35,Jubilee Hills
Hyderabad TELANGANA 500033 India
Phone
04071216240
Fax
Email
subbareddy.gunneri@biologicale.com
Source of Monetary or Material Support
Biological E.Limited, 18/1&3, Azamabad, Hyderabad - 500020, Telangana, India
Primary Sponsor
Name
Biological E.Limited
Address
Plot No. 1, Biotech Park, Phase II, Kolthur Village, Shameerpet, Medchal-Malkajgiri District, Telangana, India -500 078
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
None
None
Countries of Recruitment
India
Sites of Study
No of Sites = 35
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Ravi B Nagarajaiah
Adichunchanagiri Hospital & Research Centre
Dept of General Medicine, Ground floor, B G Nagara Nagamangala Taluk -571448 Mandya KARNATAKA
Room no:1111, 1st floor, Medical college Building Gate No, 5, Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh- 492099 Raipur CHHATTISGARH
8224014667
dratuljindal@gmail.com
Dr Shailesh Patil
Belagavi Institute of Medical Sciences
3rd floor, OPD block, BIMS Building, Dr. B. R. Ambedkar Road, Sadashiv Nagar -590001 Belgaum KARNATAKA
9480454944
bimsclinicalresearch@gmail.com
Dr Rohith H R
BGS Global Institute of Medical Sciences
No. 67, OPD block, 2nd floor, BGS Health and Education city, Uttarahalli Road, Kengeri-560060 Bangalore KARNATAKA
9035020302
drrohith.research@gmail.com
Dr Sonali Hemant Palkar
Bharati Vidyapeeth (Deemed to be University) Medical College Hospital and Research Centre
Ground floor, OPD block, Pune-Satara Road, Dhankawadi -411043 Pune MAHARASHTRA
9881008717
sonali.palkar@bharatividyapeeth.edu
Dr Prashanth S
Cheluvamba Hospital
Paediatric block, Ground floor,Sitharanga OPD, Unit B, Mysore Medical College & Research Institute, Irwin Road -570001 Mysore KARNATAKA
9606352062
drprashanths10@gmail.com
Dr Kishori Sharan Agarwal
Chirayu Hospital
Ground Floor of OPD, Kalwar Road, Hathoj-302012 Jaipur RAJASTHAN
09829092667
agarwalkishore@yahoo.com
Dr Subhasish Bhattacharyya
Chittaranjan Seva Sadan College of Obstetrics, Gynaecology & Child Health
Shubham Sudbhawana Super Hospital, Ethics Committee
Approved
Signus Hospital Ethics Committee
Approved
Siliguri Sumita Cancer R.W and E. Society
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
For active immunization for the prevention of disease caused by Measles and Rubella viruses
Patients
(1) ICD-10 Condition: Z23||Encounter for immunization,
Intervention / Comparator Agent
Type
Name
Details
Intervention
BE’s MR Vaccine (Investigational)
Single dose- 0.5 ml by subcutaneous injection to be administered subcutaneously on day 0.
Duration:
6 months post single dose of vaccine administration.
Comparator Agent
Licensed MR Vaccine from Biological E Limited (Comparator)
single dose - 0.5 ml by subcutaneous injection to be administered subcutaneously on day 0.
Duration:
6 months post single dose of vaccine administration.
Inclusion Criteria
Age From
9.00 Month(s)
Age To
12.00 Month(s)
Gender
Both
Details
1. Healthy male or female infants between 9-12 months of age at the time of the vaccination;
2. Subjects’ parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits, with access to a consistent means of telephone contact, either residential land line or mobile).
3. Written or thumb printed informed consent (including audio-visual recording of consent process) obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
4. Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature) as judged by the principal investigator
5. Subjects not participating in any other clinical trials.
ExclusionCriteria
Details
1. Subject had a history of previous measles or rubella infection or Measles Rubella containing vaccination.
2. Family history of any hypersensitivity reactions to Measles, MR or MMR vaccination(s) or allergy to any of their components.
3. Child in care, defined as a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
4. Acute disease and/or fever at the time of vaccination.
5. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the administration of study vaccine or planned use during the study period.
6. Any medical condition that in the judgment of the investigator would make subcutaneous injection unsafe.
7. Known or suspected allergy to any of the vaccine components. History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity likely to be exacerbated by any component of the study vaccines.
8. Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS)
9. Known family history of SIDS (Sudden Infant Death Syndrome).
10. Planned or elective surgery during the course of the study.
11. Infants with a known or suspected impairment of the immune function (congenital or hereditary), or those receiving immunosuppressive therapy, or received immunosuppressive therapy prior to study entry (including systemic or high doses of inhaled corticosteroids) or those who have received a parenteral immunoglobulin preparation
12. Infants who have received any blood products, cytotoxic agents, corticosteroids or radiotherapy
13. Subjects who have participated in another clinical trial of an investigational agent within last 30 days or likely to participate during the study course.
14. Inability or unwillingness of the subject’s parent/LAR to abide by the requirements of the protocol.
15. Subjects with congenital abnormalities.
16. Administration of immunoglobulins and/or any blood products during the period starting three months before the administration of study vaccine or planned administration during the study period.
17. Administration of long-acting immune-modifying drugs at any time during the study period.
18. Any criteria, which in the judgement of the Investigator, suggests that the subject would not be compliant with the study protocol.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Participant Blinded
Primary Outcome
Outcome
TimePoints
At Phase II:
1. Number and proportion of subjects with solicited local and systemic adverse events
2.Number and proportion of subjects with solicited local adverse events and systemic adverse events
3. Number and proportion of subjects with unsolicited adverse events
4. Number and proportion of subjects with any serious adverse events (SAEs)or AEs SAEs
At Phase III:
Proportion of subjects seropositive with anti-Measles IgG antibodies and anti-Rubella IgG antibodies.
At Phase II:
1. First 60 minutes of post vaccination observation period.
2. 7 consecutive days and for systemic adverse events during 14 days post vaccination.
3. 14 days post vaccination
4. 14 days post vaccination.
At Phase III:
1. 42 days post vaccination
Secondary Outcome
Outcome
TimePoints
At Phase III:
Number & proportion of subjects with solicited local & systemic adverse events
At Phase III:
60 minutes of post vaccination observation period
Number & proportion of subjects with solicited local adverse events & and systemic adverse events
7 days & systemic adverse events during 14 days post vaccination
Number & proportion of subjects with unsolicited adverse events (AEs)
42 days post vaccination.
Number & proportion of subjects with Medically attended adverse events (MAAEs), & serious adverse events (SAEs), if any,
42 days post vaccination.
Geometric mean concentrations/titres (GMCs/GMTs) of anti-Measles IgG and anti-Rubella IgG antibodies
estimated both at baseline and again at day 42.
Geometric mean fold rise (GMFR) for anti-measles IgG & anti-Rubella IgG antibody concentrations/titres
42 days from baseline i.e Day 0.
Number & proportion of subjects seropositive with anti-Measles & anti-rubella antibodies
42 days post vaccination
Number & proportion of subjects with unsolicited AEs, MAAEs, & SAEs
6 months follow up period after the vaccination
Target Sample Size
Total Sample Size="3500" Sample Size from India="3500" 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 2/ Phase 3
Date of First Enrollment (India)
01/12/2025
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="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
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 comparative, single blind, multicentre phase-II/III study to assess safety and immunogenicity of Biological E’s Measles-Rubella Vaccine. The safety and immunogenicity of this vaccine will be compared with licensed MR-Vaccine.
The target population for this study would be healthy male and female infants between 9 to 12 months of age at the time of vaccination. The total sample size to be enrolled will be 3500 healthy eligible subjects. All study subjects (N=3500) will be followed up for 6 months for long term safety assessment, post vaccination.
The study will be conducted in compliance with New Drugs and
Clinical Trials Rules, ICH and Indian good clinical practice guidelines in
force at the time of study conduct.