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CTRI Number  CTRI/2015/05/005784 [Registered on: 19/05/2015] Trial Registered Prospectively
Last Modified On: 14/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical study to compare the immune response and safety of Measles, Mumps and Rubella (MMR) vaccine manufactured by Cadila Healthcare Ltd. with MMR vaccine manufactured by Serum Institute of India Ltd. in children 15-18 months of age  
Scientific Title of Study   A prospective, randomized, single blind, parallel, active controlled, multicentre, non-inferiority, phase III clinical study to evaluate the immunogenicity and safety of single-dose and multi-dose vials of Measles Mumps and Rubella vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited compared to Measles Mumps and Rubella vaccine (Live) (Freeze-dried) of M/s Serum Institute of India Limited in healthy paediatric subjects aged 15-18 months 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
14-07. Version No.00. dated 18-07-2014  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 Ltd 
Address  Cadila Healthcare Ltd., Zydus-PTC, Sigma Commerce Zone, B/H ISCON Temple, Near Satellite Cross Roads, Ambli-Bopal Road

Ahmadabad
GUJARAT
380015
India 
Phone  07926868926  
Fax  07926868910  
Email  r.mittal@zyduscadila.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravindra Mittal  
Designation  Medical Advisor & Head - Regulatory Affairs  
Affiliation  Cadila Healthcare Ltd 
Address  Cadila Healthcare Ltd., Zydus-PTC, Sigma Commerce Zone, B/H ISCON Temple, Near Satellite Cross Roads, Ambli-Bopal Road

Ahmadabad
GUJARAT
380015
India 
Phone  07926868926  
Fax  07926868910  
Email  r.mittal@zyduscadila.com  
 
Details of Contact Person
Public Query  
Name  Dr Jayesh Sanmukhani  
Designation  Senior Manager – New Product Development  
Affiliation  Cadila Healthcare Ltd. 
Address  Cadila Healthcare Ltd., Zydus-PTC, Sigma Commerce Zone, B/H ISCON Temple, Near Satellite Cross Roads, Ambli-Bopal Road, Ahmedabad

Ahmadabad
GUJARAT
380015
India 
Phone  07926868924  
Fax  07926868910  
Email  jayeshsanmukhani@zyduscadila.com  
 
Source of Monetary or Material Support  
Cadila Healthcare Ltd., SIGMA CommerZone Near Iscon Temple & Satellite Cross Roads, Ambli-Bopal Road, Ahmedabad - 380015. Gujarat, INDIA. Phone No.: 079-2686-8900 Fax No.: 079-2686-8910 
 
Primary Sponsor  
Name  Cadila Healthcare Ltd 
Address  SIGMA CommerZone Near Iscon Temple & Satellite Cross Roads, Ambli-Bopal Road, Ahmedabad - 380015. Gujarat, INDIA. Phone No.: 079-2686-8900 Fax No.: 079-2686-8910 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr T Ramesh Babu  Gandhi General Hospital  Study Room, First Floor, Department of Pediatrics, Main Building, Gandhi General Hospital, Musheerabad
Hyderabad
ANDHRA PRADESH 		 040-27504441

ramesh_ped@yahoo.com 
Dr Uma Siddhartha Nayak  GMERS Medical College & Government Hospital, GOTRI  Room No. 501; 5th Floor, Department of Paediatric, Main Hospital Building, GMERS Medical College
Vadodara
GUJARAT 		 09327214065

umasnayak@gmail.com 
Dr Himanshu Joshi  GMERS Medical College and Government Hospital, SOLA  Room No. 34, Department of Paediatrics, Transit OPD, GMERS Medical College, Sola (SG Highway)
Ahmadabad
GUJARAT 		 9825014937

drhimanshujoshi60@gmail.com 
Dr Samarendra Mahapatro  Hi-Tech Medical College and Hospital  Paediatric OPD, Ground Floor, Hi-Tech Medical College and Hospital, Bhubaneshwar
Khordha
ORISSA 		 9437323538

samarendramahapatro@yahoo.com 
Dr Ashwani Kumar Sood  Indira Gandhi Medical College  Children OPD (Room No.7), A Block, Ground Floor, Indira Gandhi Medical College
Shimla
HIMACHAL PRADESH 		 9418300888

doc.aksood@gmail.com 
Dr Monjori Mitra  Institute of Child Health  Room No. 113, Ground Floor, Institute of Child Heath, 11, Dr. Biresh Guha street
Kolkata
WEST BENGAL 		 9831075734

monjorimr@gmail.com 
Dr B Krishnamurthy  Mysore Medical College and Research Institute  Immunization Room, Ground Floor, OPD Building, Cheluvamba Hospital, Mysore Medical College and Research Institute and Associated Hospital, Irwin Road
Mysore
KARNATAKA 		 0821-2520512
0821-2520803
bkm876@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Ethics Committee , Indira Gandhi Medical College Situated at Shimla-171001, Himachal Pradesh, India  Approved 
Ethics Committee- Institute of Child Health, Dr. Biresh Guha street, Kolkata, West Bengal-700017  Approved 
Institutional Ethics Committee (Institutional Review Board) GMERS Medical College Gotri, Gotri Road, Vadodara 390021, Gujarat  Approved 
Institutional Ethics Committee, Gandhi Medical College/ Hospital, musheerabad, Secunderabad, AP 500003  Approved 
Institutional Ethics Committee, Hi-Tech Medical College & Hospital, Health Park, Pandra, Rasulgarh, Bhubaneswar, Odisha 751025  Approved 
Institutional Ethics Committee, Mysore Medical College and Research Institute and Associated Hospitals, Irwin Road, Mysore, Karnataka 570021  Approved 
Institutional Ethics committee: GMERS Medical College, Sola, S.G. Highway, Near New Gujarat High Court, Ahmedabad  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Active immunization for the prevention of disease caused by Measles, Mumps and Rubella virus  
Patients  (1) ICD-10 Condition: Z23||Encounter for immunization,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  MMR vaccine (Live) (Freeze-dried) of M/s Serum Institute of India Limited  Each subject will be given a single dose of 0.5ml vaccine as a subcutaneous injection in the upper arm or in the anterolateral aspect of the thigh on day 0. Subjects will be followed up for 42 days after single dose of vaccine 
Intervention  Multi-dose vials of MMR vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited  Each subject will be given a single dose of 0.5ml vaccine from multidose vial given as a subcutaneous injection in the upper arm or in the anterolateral aspect of the thigh on day 0. Subjects will be followed up for 42 days after single dose of vaccine 
Intervention  Single-dose vials of MMR vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited  Each subject will be given a single dose of 0.5ml vaccine from single dose vial given as a subcutaneous injection in the upper arm or in the anterolateral aspect of the thigh on day 0. Subjects will be followed up for 42 days after single dose of vaccine 
 
Inclusion Criteria  
Age From  15.00 Month(s)
Age To  18.00 Month(s)
Gender  Both 
Details  1. Healthy paediatric subjects of either sex aged 15 months to 18 months
2. Informed consent of the parents/guardians and their willingness to be followed up for at least 6 weeks after vaccination of their child
3. Parents/guardians with adequate literacy to fill the diary cards 
 
ExclusionCriteria 
Details  1. Subjects with a history of anaphylaxis or serious reactions to other vaccines, neomycin, gelatin and / or albumin
2. Subjects with a history of previous measles, mumps or rubella infection or MMR vaccination, or if they had been exposed to any of these three diseases within 30 days of trial commencement
3. Subjects having received measles vaccine less than 3 months back
4. Subjects with a history of convulsions, epilepsy, other central nervous system diseases, severe disease of haematopoietic system, decompensated heart disease or impaired renal function
5. Subjects with an acute febrile illness at the time of randomization
6. Any other parenteral vaccine administration within 30 days of initiation of the study or during the study
7. A history of serious chronic illness, major congenital defects, immunosuppression (immunosuppressive illness or therapy)
8. Subjects who have received blood, blood products or immunoglobulins during the preceding 3 months
9. Subjects with any other clinically significant concurrent illness affecting immune response after vaccination 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of subjects who are sero-positive for measles, mumps and rubella at the end of study in the two groups  42 days following vaccination 
 
Secondary Outcome  
Outcome  TimePoints 
Geometric mean titre of anti-measles, anti-mumps and anti-rubella antibodies in the two groups at the end of the study  42 days following vaccination 
Sero-conversion rate at the end of the study for measles, mumps and rubella who were sero-negative before randomization in the two groups  42 days following vaccination 
 
Target Sample Size   Total Sample Size="327"
Sample Size from India="327" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   05/06/2015 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This is a randomized, single blind, parallel group, multicentre, non-inferiority phase III clinical trial to evaluate the immunogenicity and safety of single-dose and multi-dose vials of MMR vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited compared to MMR vaccine (Live) (Freeze-dried) of M/s Serum Institute of India Limited in healthy paediatric subjects aged 15-18 months. Three hundred and twenty seven subjects will be randomized to receive either MMR vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited (single-dose or multi-dose vial) or MMR vaccine (Live) (Freeze-dried) of Serum Institute of India Limited according to the centralized computer generated randomization plan. A pre vaccination and a post vaccination (day 42) blood sample will be collected to determine antibody titres attained after vaccination using ELISA kit manufactured by IBL International GMBH Germany. A titre >300 Milli International Unit (mIU)/ml for measles, >12 Units (U)/ml for mumps and >12 International Units (IU)/ml for rubella will be considered as sero-positive. The primary efficacy end point will be the proportion of subjects who are sero-positive for measles, mumps and rubella at the end of study in the two groups. The safety of the vaccine will be assessed by recording the adverse events occurring during the entire course of the study.

 
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