FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2016/07/007109 [Registered on: 20/07/2016] Trial Registered Prospectively
Last Modified On: 25/11/2019
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 protective efficacy of Biological Es Measles-Rubella Vaccine in 9-12 months old Infants in India. 
Scientific Title of Study   A Phase II/III randomised, comparative, multicentre Study to Evaluate the Safety and Immunogenicity of Biological E’s Live, Attenuated Measles-Rubella Vaccine (MR) in 9-12 month old Healthy Infants. 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
BECT036/MRV-PII/III/CTP-02 Version no:2.0 dated 13.06.16  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arani Chatterjee  
Designation  Sr Vice President 
Affiliation  Biological E.Limited 
Address  Biological E.Limited, 18/1&3,Azamabad, Hyderabad, Telangana, India

Hyderabad
ANDHRA PRADESH
500020
India 
Phone  04030214070  
Fax  04027675003  
Email  arani.chatterjee@biologicale.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Arani Chatterjee  
Designation  Sr Vice President 
Affiliation  Biological E.Limited 
Address  Biological E.Limited, 18/1&3,Azamabad, Hyderabad, Telangana, India

Hyderabad
ANDHRA PRADESH
500020
India 
Phone  04030214070  
Fax  04027675003  
Email  arani.chatterjee@biologicale.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Arani Chatterjee  
Designation  Sr Vice President 
Affiliation  Biological E.Limited 
Address  Biological E.Limited, 18/1&3,Azamabad, Hyderabad, Telangana, India

Hyderabad
ANDHRA PRADESH
500020
India 
Phone  04030214070  
Fax  04027675003  
Email  arani.chatterjee@biologicale.co.in  
 
Source of Monetary or Material Support  
Biological E.Limited  
 
Primary Sponsor  
Name  Biological ELimited  
Address  18/1&3,Azamabad,Hyderabad, Telangana, India 500020  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
None  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr B Krishna Murthy  Cheluvamba Hospital  Dept. of Paediatrics, Cheluwamba Hospital, Mysore Medical College & Research Institute Irwin Road, Mysore – 570001, Karnataka, India Mysore KARNATAKA
Mysore
KARNATAKA 		 09448057007
08212520803
bkm876@gmail.com 
Dr Ritabrata Kundu  Institute of Child Health  Dept. of Paediatrics, Institute of Child Health, 11 Dr. Biresh Guha Street, Kolkata – 700017, West Bengal, India.
Kolkata
WEST BENGAL 		 09831194865
033-22905626
rkundu22@gmail.com 
Dr P Venugopal  King George Hospital  Dept. of Paediatrics, King George Hospital Collectorate Junction, Maharanipeta, Visakhapatnam – 530002, ANDHRA PRADESH
Visakhapatnam
ANDHRA PRADESH 		 09848027203
08912727203
fbnc.amc@gmail.com 
Dr Amlan Choudhary  KPC Medical college  Dept. of Paediatrics, KPC Medical College, Kolkata, 1F, Raja SC Mullick Road, Kolkata - 700032, West Bengal, India. Kolkata WEST BENGAL
Kolkata
WEST BENGAL 		 09432909111
03324298488
pedamlan1@gmail.com 
Dr Madhu Gupta  Postgraduate Institute of Medical Education & Research (PGIME&R)  Department of Community Medicine & School of Public Health Postgraduate Institute of Medical Education & Research (PGIME&R), Chandigarh - 160 012 (India)
Chandigarh
CHANDIGARH 		 09914208226
091-1722755223
madhugupta21@gmail.com 
Dr Ramchandra Keshav Dhongade  Sant Dnyaneshwar Medical Education & Research Centre  Dept. of Paediatrics, Sant Dnyaneshwar Medical Education & Research Centre, Opp.: Vijay Cinema, Laxmi Road Pune – 411030, Maharashtra, India Pune MAHARASHTRA
Pune
MAHARASHTRA 		 09822037483
02024465419
ramdhongade@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Institutional Ethics Committee, Institute of Child Health  Approved 
Institutional Ethics Committee, PGIMER, Chandigarh   Approved 
Institutional Ethics Committee- KPC Medical college & Hospital   Approved 
Institutional Ethics Committee- Mysore Medical college & Research Institute & associated hospitals   Approved 
Institutional Ethics Committee-King George Hospital   Approved 
Institutional Review Board- Sant Dnyaneshwar Medical Education Research centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
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  Measles-Rubella (MR) Vaccine, Live, Attenuated (Freeze-dried) of BE Ltd.  BE’s live attenuated measles-rubella vaccine 0.5 mL per dose to be administered subcutaneously on day 0. Subjects in group-I will be further equally randomised (100 subjects/batch) to receive vaccine dose from one of the three batches. 
Comparator Agent  SIIL’s live attenuated MR-Vacâ„¢ vaccine   SIIL’s live attenuated MR-Vacâ„¢ vaccine 0.5 mL per dose to be administered subcutaneously on day 0.  
 
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 first vaccination;
2.Infants free of obvious health problems as established by medical history and physical examination before entering the study.
3.Parent or LAR willing to provide written informed consent.
4.Willing to strictly follow the study protocol requirements.
 
 
ExclusionCriteria 
Details  1.Serious adverse event to any earlier vaccinations, as respiratory difficulty, angioedema and anaphylaxis;
2.Family history of any hypersensitivity reactions to Measles, MR or MMR vaccination(s) or allergy to any of their components.
3.Acute or chronic illness or major congenital defects;
4.Exposure to measles and rubella ≤30 days before study start;
5.Use of blood products within 3 months before the vaccination;
6.Use of any vaccine type within 30 days before the vaccination of the study;
7.Any confirmed or suspected condition wherein the child is immunocompromised or receiving immunosuppressive medication;
8.Use of any kind of investigational medication within 3 months before the study vaccination;
9.Coagulopathies diagnosed by a physician or report of capillary fragility (ex: bruises or bleedings without justifiable cause);
10.A history of neurologic disorders or seizures;
11.Any confirmed or suspected Infection with HIV, HCV and Hepatitis B (HBsAg).
12.Any criteria, which in the opinion of the Investigator, suggests that the child would not be compliant with the requirements of the study protocol.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Proportion of subjects seroconverted.
2.Geometric mean concentrations.
3.Proportion of subjects who were not seroconverted at baseline, achieving ≥4-fold increase in antibody titres
4.Proportion of subjects who were seroconverted at baseline, achieving ≥2-fold increase in antibody titres.
5.Non-inferiority in terms of difference in proportion of subjects seroconverted. 		 1.At day 42
2.At day 42
3.At day 42
4.At day 42
5.At day 42 
 
Secondary Outcome  
Outcome  TimePoints 
Number and percentage of:
1.solicited local and systemic adverse events (AEs)
2.solicited local and systemic AEs.
3.unsolicited AEs.
4.Rate of SAEs and medically attended AEs.
5.Number and percentage of clinically significant abnormal vital signs (Pulse, Axillary body temperature and Respiratory rate) for any clinically significant changes. 		 1.during first 1 hour of post-vaccine administration.
2.during 7-day (Day 0-6) post vaccination period.
3.up to day 42 after the first vaccination.
4.until day 42 after the first vaccination.
5.At each visit. 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
Final Enrollment numbers achieved (Total)= "600"
Final Enrollment numbers achieved (India)="600" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   29/07/2016 
Date of Study Completion (India) 07/03/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a randomized comparative, 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 SIIL’s MR-Vacâ„¢ vaccine. 

There will be two treatment groups viz., subjects receiving Biological E.’s MR vaccine (Group-1) and subjects receiving SIIL’s licensed MR-Vac® vaccine (Group-2). The target population for this study would be healthy male and female infants between 9-12 months of age at the time of first vaccination.all enrolled subjects would be followed up for a period of 42 days after a single primary dose of MR vaccine administration.

Only optimal quantity of venous blood sample approximately 3.5 mL for Immunological assay tests will be drawn twice during the study period, once at screening (visit-1) and again 42 days (Visit-3) after the single dose.Vital signs will be recorded at all specified visits. 

In sync with the WHO mandate and Indian commitment for introduction of MR or MMR vaccine into the national routine immunization programme,Biological E. initiated MR vaccine development.



 
Close