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1 Clinical Trial Details (PDF Generation Date :- Sun, 07 Apr :55:48 GMT) CTRI Number CTRI/2009/091/ [Registered on: 09/10/2009] - Last Modified On 14/08/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Vaccine Biological Preventive Randomized, Parallel Group, Active Controlled Trial A study to test the non-inferiority in children of a combined vaccine developed by Biologicals for protection against multiple diseases, i.e. measles, mumps, rubella and varicella, versus co-administration of separate vaccines for some of these diseases A phase IIIb, open, randomised, multicentre, primary study in healthy children, to establish the noninferiority of (GSK) Biologicals MeMuRu-OKA vaccine (administered at 9 and 15 months of age) versus Priorix (9 months of age) and Priorix co-administered with Varilrix at 15 months of age (comparator) and also to evaluate the non-inferiority of Priorix (9 months of age) and MeMuRu-OKA vaccine (15 months of age) versus the comparator, all administered subcutaneously as twodose primary vaccination course. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Final Protocol (23 May 2008) Protocol Number NCT ClinicalTrials.gov Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study > NIL Type of Sponsor NIL List of Countries of Principal Investigator DrSanjay Kewalchand Lalwani Source of Monetary or Material Support Primary Sponsor Details Biologicals 89, Rue de linstitut 1330, Rixensart, Belgium Pharmaceutical industry-global of Site Site Phone/Fax/ Bharatiya Vidyapeet Deemed University Hospital Paediatrics, Pune Satara Road,Kataraj, Dhankad wada, Pune. Pune Dr Maria P Silveira Goa Medical College Paediatrics, Bambolim Complex, Goa North Goa GOA Ashish Bavdekar K.E.M Hospital Paediatrics, Sardar Moodliar Road, Pune Pune Balasubramanian Sundaram Sukanta Chatterjee Dr Sylvan John Rego Kanchi Kamakoti Childs Trust Hospital Medical College Calcutta St. Johns Hospital and Medical College Paediatrics, #12-A, Nageswara Road, Nungambakkam, Chennai,. Chennai TAMIL NADU Paediatrics, 88 College Street, Kolkata Kolkata WEST BENGAL Paediatrics, St. Johns Hospital and Medical College, sanjaylalwani2007@red iffmail.com mimisil5@hotmail.com bavdekar@vsnl.com sbsped@gmail.com sukantachatterjee@hot mail.com sylvanrego@yahoo.co m page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria KARNATAKA of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics committee KEM Hospital research centre Goa Medical College Ethics Committee Institute Ethics Committee, Bharati Vidyapeeth University Institute Ethics Committee, Kanchi kamakoti child trust hospital and childs trust Medical Research foundation Institutional Ethical Review Board, Institutional Ethics Committee, Medical College Kolkata Status Approved 10/03/2009 Not Available Approved 05/02/2009 Not Available Approved 06/05/2009 Not Available Approved 10/08/2009 Not Available Approved 21/10/2008 Not Available Approved 20/08/2009 Not Available Date Approved/Obtained 20/11/2008 Health Type Healthy Human Volunteers Condition Measles, Mumps, Rubella and Varicella Type Details Intervention GSK Biologicals investigational MMRV vaccine doses at 9 and 15 months of age Comparator Agent Varilrix? The vaccine will be administered concomitantly with Priorix at 15 months of age. Comparator Agent Priorix Subcutaneous injection. One dose at 9 months of age or 2 doses at 9 & 15 months of age depending on group allocation. Age From Age To Gender Details 9.00 Month(s) Month(s) Both Inclusion Criteria - Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. - Male or female subjects between and including 9 and 10 months of age at the time of the first vaccination. - Written informed consent obtained from the the parent or guardian of the subject. - Healthy subjects as established by medical history and clinical examination before entering into the study. Exclusion Criteria Exclusion Criteria page 3 / 5

4 Details - Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. - Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. - Planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days prior to administration of any dose of the study vaccine, up to 42 days after the vaccine dose with the exception of hepatitis A vaccine and oral poliovirus vaccine. - Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-registered product. Previous vaccination against measles, mumps, rubella and varicella. - History of measles, mumps, rubella and/or varicella diseases. - Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the start of the study. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. - A family history of congenital or hereditary immunodeficiency. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccines including neomycin. - Major congenital defects or serious chronic illness. - History of any neurologic disorders or seizures. Acute disease at the time of enrolment. - Axillary temperature above 37.5 C (99.5 F) / Rectal temperature above 38 C (100.4 F). - Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period. - Presence of a susceptible high-risk person in the same household during the study period. Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Open Label Primary Outcome Outcome Timepoints Seroconversion rates for measles, mumps, rubella and varicella. Approximately 42 to 56 days after the second vaccine dose. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Seroconversion rates for measles, mumps and rubella. Measles, mumps, rubella and varicella antibody titres. Occurrence of solicited local symptoms. Occurrence of solicited general symptoms. Occurrence of unsolicited signs and symptoms. Occurrence of serious adverse events Total Sample Size=450 Sample Size from =450 Approximately 42 to 56 days after the first vaccine dose. 42 to 56 days after the first and second dose. Within 4 days (Day 0 to 3) after vaccination. Within 43 days (Day 0? 42) after vaccination. Within 43 days (Day 0? 42) after vaccination.. From the first study dose up to study end (i.e. From Day 0 up to 42 to 56 days after the second dose) page 4 / 5

5 Powered by TCPDF ( 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 09/11/2009 No Date Specified Years=1 Months=3 Days=12 Not Applicable Completed none yet The purpose of this study is to assess non-inferiority of two different vaccination regimens using GSK Biologicals MMRV vaccine (two doses at 9 and 15 months) or Priorix (9 months) and one dose of MMRV vaccine (15 months) to the current standard of care which is Priorix administered at 9 months of age followed by concomitant administration of Priorix with Varilrix at 15 months of age in a measles endemic environment such as. page 5 / 5