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1 Clinical Trial Details (PDF Generation Date :- Sat, 17 Nov :20:06 GMT) CTRI Number Last Modified On 10/05/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/05/ [Registered on: 30/05/2013] - Trial Registered Prospectively No Interventional Vaccine Medical Device Randomized, Parallel Group, Active Controlled Trial Clinical Study to assess safety and immune response of MMR subcutaneous vaccination by Disposable Syringe Jet Injector as compared to Needle Syringe method in month old children. A Phase IV, Non-Inferiority, Observer blind Randomized Clinical Study Comparing Safety And Immunogenicity Of Measles-Mumps-Rubella (MMR) Subcutaneous Vaccination By Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe For The Administration In Healthy Children In Aged 15 To 18 Months. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) MMR-01/12 Version 3.2 Dated 02 February 2015 Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Details Contact Person (Scientific Query) Dr Prasad Kulkarni Medical Director Serum Institute of Ltd. Phone Fax /2, Hadapsar, Off Soli Poonawalla Road, , drpsk@seruminstitute.com Details Contact Person (Public Query) Dr Prasad Kulkarni Medical Director Serum Institute of Ltd. 212/2, Hadapsar, Off Soli Poonawalla Road, , page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Source of Monetary or Material Support > Program for Appropriate Technology in Health, Seattle, WA USA Type of Sponsor NIL List of Countries of Principal Investigator Dr D Ramaganeshan Dr Padmasani Venkat Ramanan Dr Jitendra Oswal Dr Ashish Bavdekar Dr C D Aundhkar Dr Ashish Bavdekar Primary Sponsor Details Serum Institute of Ltd 212/2, Hadapsar, Off Soli Poonawalla Road, Pharmaceutical industry-n NIL of Site Site Phone/Fax/ Pediatrics King George Hospital Pediatrics Sri Ramachandra Medical Centre Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital Pediatrics, KEM Hospital Research Centre Pediatrics, Krishna Sciences Deemed University Shirdi Sai Baba Rural Hospital KEM Hospital Reseacrh Centre KGH Down Rd, Jagadamba Area, Maharani Peta, fbnc.amc@gmail.com Visakhapatnam, Andhra Pradesh Visakhapatnam ANDHRA PRADESH Sri Ramachandra Medical Centre No 1 Ramachandra Nagar Porur Chennai Chennai TAMIL NADU Satara Road, Katraj, Dhankawadi Sardar Moodliar Road, Rasta Peth, Pediatrics, Krishna Sciences Deemed University, Agashivnagar, Malkapur, Karad Maharashtra Satara Shirdi Sai Baba Rural Hospital KEM Hospital Reseacrh Centre Vadu Rural Health Program Vadu Budruk Taluka padmasani2001@yaho o.com researchpedpune@gm ail.com kemhrc@vsnl.net aundhakarcd@gmail.co m kemhrc@vsnl.net page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Shirur, of Committee Approval Status Date of Approval Is Independent Ethics Committee? Committee, Bharati Vidyapeeth Deemed University for Dr Oswal Committee, KEM Hospital Research Centre for Dr Bavdekar Committee, King George Hospital for Dr Ramaganeshan Committee, Krishna Sciences for Dr Aundhkar Committee, Sri Ramachandra University for Dr Padmasani Aundhkar Bavdekar Oswal Ramaganeshan Status Approved 01/09/2014 No Approved 21/04/2014 No Approved 02/06/2015 No Approved 05/03/2015 No Approved 03/07/2015 No Approved 15/06/2015 Yes Approved 22/08/2014 Yes Approved 22/08/2014 Yes Approved 01/07/2015 Yes Date Approved/Obtained 01/06/2015 Health Type Healthy Human Volunteers Condition Prevention of Measeles, Mumps and Rubella in infants aged 15 to 18 months by subcutaneous vaccination. Type Details Comparator Agent Intervention MMR vaccine of Serum Institute of Ltd to be administered by Needle and Syringe MMR vaccine of Serum Institute of Ltd to be administered by Disposable-Syringe Jet Single dose of 0.5 ml s.c. on anterolateral aspect of thigh to be administered by Needle and Syringe at 15 to 18 months of age Single dose of 0.5 ml s.c. on anterolateral aspect of thigh to be administered by page 3 / 5

4 Inclusion Criteria Age From Age To Gender Details Injector - Stratis Month(s) Month(s) Both Inclusion Criteria Disposable-Syringe Jet Injector - Stratis at 15 to 18 months of age 1)Normal healthy infants of age months at the time of the screening and have not received their first dose of MMR vaccine. 2)Previously received a measles monovalent vaccine at 9 months, as confirmed by the childhood vaccination record. 3)Parents or legal guardians of subject willing to give written informed consent and willing to comply with study protocol. 4)Free of obvious health problems as established by medical history and screening evaluation including clinical examination. 5)The participant should be the resident of study area. Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Computer generated randomization Other Outcome Assessor Blinded Exclusion Criteria 1)Infant subject participating in other clinical trial or planned participation in another clinical trial during the present trial period 2)Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy such as systemic corticosteroids therapy. 3)Infant with history of allergy or systemic hypersensitivity to any of the vaccine component or to a vaccine containing the same substances. 4)Infant with history of epilepsy or a seizure disorder or neurodevelopmental disorders. 5)Infant who receive blood or blood derived products in the past. 6)Clinical history of measles, mumps, or rubella infection. 7)Previous history of MMR/MR combination vaccine or Rubella vaccine immunization. 8)Known history of a bleeding disorder or any condition that may be associated with prolonged bleeding time. 9)History of egg allergy to eggs, neomycin or gelatin. 10)An acute or chronic infection requiring systemic antimicrobial therapy (antibiotic or antiviral) within the past 21 days. 11)Infants with leukemia, lymphoma, or any other cancer or neoplasm. 12)Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, neurological, cardiovascular, metabolic, hepatic or renal functional abnormality, as determined by medical history, and physical examination tests, which in the opinion of the investigator, might interfere with the study objectives 13)History of febrile illness at the time of vaccination is a temporary exclusion criterion. 14)Infant with any other condition, which, in the opinion of the investigator would jeopardize the safety or rights of the infant participating in the study or making it unlikely the subject could complete the protocol. Primary Outcome Outcome Timepoints Seropositivity of individual infant for the diseases 35 days after administration of the vaccine page 4 / 5

5 Powered by TCPDF ( PDF of Trial measles, mumps and rubella Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 4 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Comparrison of Geometric Mean titers (GMTs) for anti-measles, anti-mumps and anti-rubella antibodies Day 35 Solicited adverse reactions Day 14 Unsolicited adverse events Day 35 serious adverse events(saes) Day 35 Total Sample Size=340 Sample Size from =340 01/07/2013 No Date Specified Years=2 Months=0 Days=0 Not Applicable Completed This is a randomized, observer blind, non-inferior, parallel group, multi-centre clinical study to determine and compare immunogenicity and reactogenicity of MMR vaccine of SIIL delivered either with disposable-syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 n infants aged 15 to 18 months. Sera samples will be analyzed by ELISA for seroconversion / seropositivity for each individual component of vaccine i.e. measles, mumps and rubella at 35 days after administration of a single dose of MMR vaccine of Serum Institute of. page 5 / 5