CTRI Number	CTRI/2009/091/000750 [Registered on: 09/10/2009]
Last Modified On:	14/08/2014
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study Modification(s)	Vaccine Biological Preventive
Study Design	Randomized, Parallel Group, Active Controlled Trial
Public Title of Study Modification(s)	A study to test the non-inferiority in children of a combined vaccine developed by GlaxoSmithKline Biologicals for protection against multiple diseases, i.e. measles, mumps, rubella and varicella, versus co-administration of separate vaccines for some of these diseases
Scientific Title of Study Modification(s)	A phase IIIb, open, randomised, multicentre, primary study in healthy children, to establish the noninferiority of GlaxoSmithKline (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 Modification(s)	Secondary ID  Registry  109995 Final Protocol (23 May 2008)   Protocol Number  NCT00969436  ClinicalTrials.gov
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Shailesh Mehta  Address  Dr. Annie Besant Road Mumbai MAHARASHTRA 400030 India Mumbai MAHARASHTRA 400030 India  Phone  00912224959611   Fax  00912224951326   Email  shailesh.i.mehta@gsk.com
Details Contact Person Scientific Query Modification(s)	Name  Dr Shailesh Mehta  Address  Dr. Annie Besant Road Mumbai MAHARASHTRA 400030 India Mumbai MAHARASHTRA 400030 India  Phone  00912224959611   Fax  00912224951326   Email  shailesh.i.mehta@gsk.com
Details Contact Person Public Query Modification(s)	Name  Dr Shailesh Mehta  Address  Dr. Annie Besant Road Mumbai MAHARASHTRA 400030 India Mumbai MAHARASHTRA 400030 India  Phone  00912224959611   Fax  00912224951326   Email  shailesh.i.mehta@gsk.com
Source of Monetary or Material Support	NIL
Primary Sponsor Modification(s)	Name  GlaxoSmithKline Biologicals  Address  89, Rue de lInstitut 1330, Rixensart, Belgium  Type of Sponsor  Pharmaceutical industry-Global
Details of Secondary Sponsor	Name  Address  NIL
Countries of Recruitment Modification(s)	India
Sites of Study Modification(s)	No of Sites = 6   Contact Person  Name of Site  Site Address  Phone/Fax/Email  DrSanjay Kewalchand Lalwani  Bharatiya Vidyapeet Deemed University Hospital  Department of Paediatrics, Pune Satara Road,Kataraj, Dhankad wada, Pune. Pune   9220243789 sanjaylalwani2007@rediffmail.com  Dr Maria P Silveira  Goa Medical College  Department of Paediatrics, Bambolim Complex, Goa-403202 North Goa   910832-2495385 mimisil5@hotmail.com  Ashish Bavdekar   K.E.M Hospital  Department of Paediatrics, Sardar Moodliar Road, Pune-411 011 Pune   912066037342 bavdekar@vsnl.com  Balasubramanian Sundaram  Kanchi Kamakoti Childs Trust Hospital   Department of Paediatrics, #12-A, Nageswara Road, Nungambakkam, Chennai, India. Chennai   09104442001800 sbsped@gmail.com  Sukanta Chatterjee   Medical College Calcutta  Department of Paediatrics, 88 College Street, Kolkata -700073 Kolkata   913322198119 sukantachatterjee@hotmail.com  Dr Sylvan John Rego  St. Johns Hospital and Medical College Bangalore  Department of Paediatrics, St. Johns Hospital and Medical College, Bangalore-560034 Bangalore   918022065000 sylvanrego@yahoo.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 6   Name of Committee  Approval Status  Ethics committee KEM Hospital research centre  Approved  Goa Medical College Ethics Committee  Approved  Institute Ethics Committee, Bharati Vidyapeeth University  Approved  Institute Ethics Committee, Kanchi kamakoti child trust hospital and childs trust Medical Research foundation  Approved  Institutional Ethical Review Board, Bangalore  Approved  Institutional Ethics Committee, Medical College Kolkata   Approved
Regulatory Clearance Status from DCGI Modification(s)	Status  Approved/Obtained
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Healthy Human Volunteers  Measles, Mumps, Rubella and Varicella
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Intervention  GSK Biologicals investigational MMRV vaccine 208136  2 doses at 9 and 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.  Comparator Agent  Varilrix?  The vaccine will be administered concomitantly with Priorix at 15 months of age.
Inclusion Criteria Modification(s)	Age From  9.00 Month(s) Age To  10.00 Month(s) Gender  Both  Details  - 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.
ExclusionCriteria	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 Modification(s)	Computer generated randomization
Method of Concealment Modification(s)	Centralized
Blinding/Masking Modification(s)	Open Label
Primary Outcome Modification(s)	Outcome  TimePoints  Seroconversion rates for measles, mumps, rubella and varicella.  Approximately 42 to 56 days after the second vaccine dose.
Secondary Outcome Modification(s)	Outcome  TimePoints  Measles, mumps, rubella and varicella antibody titres.   42 to 56 days after the first and second dose.  Occurrence of serious adverse events  From the first study dose up to study end (i.e. From Day 0 up to 42 to 56 days after the second dose)  Occurrence of solicited general symptoms.  Within 43 days (Day 0 ? 42) after vaccination.  Occurrence of solicited local symptoms.   Within 4 days (Day 0 to 3) after vaccination.  Occurrence of unsolicited signs and symptoms.  Within 43 days (Day 0 ? 42) after vaccination..  Seroconversion rates for measles, mumps and rubella.  Approximately 42 to 56 days after the first vaccine dose.
Target Sample Size Modification(s)	Total Sample Size="450" Sample Size from India="450"
Phase of Trial Modification(s)	Phase 3
Date of First Enrollment (India) Modification(s)	09/11/2009
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial Modification(s)	Years="1" Months="3" Days="12"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	none yet
Brief Summary Modification(s)	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 India.