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CTRI Number  CTRI/2017/05/008701 [Registered on: 30/05/2017] 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 vaccine for prevention of Measles and Rubella diseases (MR vaccine) manufactured by Cadila Healthcare Ltd. with MR vaccine manufactured by Serum Institute of India Ltd. in children 9-12 months of age  
Scientific Title of Study   A prospective, randomized, single blind, parallel, active controlled, multicentre, phase II / III clinical study to evaluate the immunogenicity and safety of Measles & Rubella vaccine (Live) I.P. (Freeze Dried) – Single Dose and Multi Dose formulations of M/s Cadila Healthcare Limited compared to Measles and Rubella vaccine (Live) I.P. (Freeze Dried) of M/s Serum Institute of India Limited in healthy paediatric subjects aged 9-12 months 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
16-06; version No.00 dated 13-10-2016  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
380058
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
380058
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
380058
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 = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K Siva Ram Prasad  Gandhi Hospital  Department of Pediatrics, 1st Floor, Gandhi Hospital, Musheerabad, Secunderabad
Hyderabad
ANDHRA PRADESH 		 9440424545

sivaram175@yahoo.com 
Dr Rajib Kumar Ray  Hi-Tech Medical College and Hospital  Paediatric OPD, Ground Floor, Hi-Tech Medical College and Hospital, Bhubaneshwar
Khordha
ORISSA 		 9338089618

drrajib2007@gmail.com 
Dr Monjori Mitra  Institute of Child Health   Room No. 113, Ground Floor, ICH, 11, Dr. Biresh Guha street
Kolkata
WEST BENGAL 		 033-22905686

monjorimr@gmail.com 
Dr Sumantra Sarkar  IPGMER & SSKM Hospital  Department of Pediatrics, IPGMER & SSKM Hospital, A.J.C. Bose Road
Kolkata
WEST BENGAL 		 9433090390

drsumantrasarkar@gmail.com 
Dr Swapnil Janbandhu  Lifepoint Multispeciality Hospital  Research Room, 3rd Floor, Lifepoint Multispeciality Hospital, 145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Pimpri-Chinchwad Wakad
Pune
MAHARASHTRA 		 9028756287

janbandhu.swapnil117@gmail.com 
Dr Dinesh Chandra Pandey  MV Hospital And Research Centre   Research Room, MV Hospital, 314/13 ,Mirza Mandi, Chowk
Lucknow
UTTAR PRADESH 		 0522-2258215

mvhrclko@gmail.com 
Dr Chandrakant Bokade   Nagpur Government Medical college and Hospital  HOD Room, Department of Paediatrics, 1st Floor
Nagpur
MAHARASHTRA 		 9373111532

cmbokade77@gmail.com 
Dr N Ravi Kumar  Niloufer Hospital (Osmania Medical College)  Research Room, First Floor, Niloufer Hospital (OPD Building), Lakdikapol
Hyderabad
ANDHRA PRADESH 		 9392393394

ravik1961@yahoo.com 
Dr Ashish Dhongade  Sant Dnyaneshwar Medical Education Research Centre  OPD, Ground Floor, Shaishav Hospital, 695/A, Sadashiv Peth, Laxmi Road, Opp. Vijay Talkies
Pune
MAHARASHTRA 		 9011095436

adhongade1@gmail.com 
Dr Kapil Garg  SMS Medical College  Professors chamber (Dr. Kapil Garg), 3rd Floor,Jay Kay Lon Hospital
Jaipur
RAJASTHAN 		 01412619827

drkapilgargjkl@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Ethics Committee, Osmania medical College, Koti, Hyderabad – 500059  Approved 
Ethics Committee- Institute of Child Health, Dr. Biresh Guha street, Kolkata, West Bengal-700017   Approved 
Institutional Ethics Committee, 1st floor, MV Hospital And Research Centre, 314/13 ,Mirza Mandi, Chowk, Lucknow -226003   Approved 
Institutional Ethics Committee, Department of Pharmacology, Government Medical College, Nagpur – 440003, Maharashtra  Approved 
Institutional Ethics Committee, Gandhi Medical College/ Hospital, musheerabad, Secunderabad, Telangana  Approved 
Institutional Ethics Committee, Hi-Tech Medical College & Hospital, Health Park, Pandra, Rasulgarh, Bhubaneswar, Odisha 751025   Approved 
IPGME & R Research Oversight Committee, Institute of Post Graduate Medical Education and Research (IPGME & R) 244, AJC Bose Road, Kolkata  Approved 
LPR Ethics Committee, Lifepoint Multispeciality Hospital Pvt Ltd., 145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune  Approved 
Sant Dnyaneshwar Medical Education Research Center, Institutional Board 695-A, Sadashiv Peth, Laxmi Road, Opp. Vijay Talkies, Pune411030  Approved 
The Ethics Committee, S.M.S. Medical College and Attached Hospitals, Jaipur First Floor, Dhanvantri OPD Block, S.M.S. Hospital, J.L.N. Marg, Jaipur   Approved 
 
Regulatory Clearance Status from DCGI  
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 and Rubella viruses  
Patients  (1) ICD-10 Condition: Z23||Encounter for immunization,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Measles & Rubella vaccine (Live) I.P. (Freeze Dried) – Multi Dose 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 6 months after single dose of vaccine 
Intervention  Measles & Rubella vaccine (Live) I.P. (Freeze Dried) – Single Dose of M/s Cadila Healthcare Limited  Each subject will be given a single dose of 0.5ml vaccine 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 6 months after single dose of vaccine 
Comparator Agent  Measles and Rubella vaccine (Live) I.P. (Freeze Dried) of M/s Serum Institute of India Limited  Each subject will be given a single dose of 0.5ml vaccine 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 6 months after single dose of vaccine 
 
Inclusion Criteria  
Age From  9.00 Month(s)
Age To  12.00 Month(s)
Gender  Both 
Details  1. Healthy paediatric subjects of either sex aged 9 months to 12 months
2. Informed consent of either parent (mother or father) and their willingness to
be followed up for at least 6 months after vaccination of their child
3. Parents with adequate literacy to fill the diary cards 
 
ExclusionCriteria 
Details  1. Subjects with a history of anaphylaxis or serious reactions to other vaccines, gelatin and / or albumin
2. Subjects with a history of previous measles / rubella infection or vaccination with measles / rubella containing vaccine or if they had been exposed# to measles or rubella virus within 30 days of trial commencement
3. Subjects with a history of convulsions, epilepsy, other central nervous system
diseases, severe disease of haematopoietic system, decompensated heart disease or impaired renal function
4. Subjects with an acute febrile illness at the time of randomization
5. Any other vaccine administration within 30 days of initiation of the study
6. A history of serious chronic illness, major congenital defects, immunosuppression (immunosuppressive illness or therapy)
7. Subjects who have received blood, blood products or immunoglobulins during the preceding 3 months
8. 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 and rubella   6 weeks following vaccination 
 
Secondary Outcome  
Outcome  TimePoints 
Seroconversion rate for measles and rubella in subjects who were seronegative
before randomization  		 6 weeks following vaccination 
Geometric mean titre of anti-measles and anti-rubella antibodies  6 weeks following vaccination 
Local and systemic adverse events  6 weeks and 6 months following vaccination 
Serious adverse events reported  6 weeks and 6 months following vaccination 
Overall tolerability evaluation  6 weeks and 6 months following vaccination 
 
Target Sample Size   Total Sample Size="615"
Sample Size from India="615" 
Final Enrollment numbers achieved (Total)= "619"
Final Enrollment numbers achieved (India)="619" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   12/06/2017 
Date of Study Completion (India) 24/03/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
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 II / III clinical trial to evaluate the immunogenicity and safety of single-dose and multi-dose formulations of  Measles & Rubella vaccine (Live) I.P. (Freeze Dried) of M/s Cadila Healthcare Limited compared to Measles and Rubella vaccine (Live) I.P. (Freeze Dried) of M/s Serum Institute of India Limited in healthy paediatric subjects aged 9-12 months. Six hundred and fifteen subjects will be randomized to receive either MR vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited (single-dose or multi-dose formulation ) or MR vaccine (Live) (Freeze-dried) of Serum Institute of India Limited according to the centralized computer generated randomization plan and will be followed up for 6 months. A pre vaccination and a post vaccination (week 6) blood sample will be collected to determine antibody titres attained after vaccination using ELISA kit manufactured by IBL International GMBH Germany. A titre >200 Milli International Unit (mIU)/ml for measles and > 8 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 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 (6 months) 
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