REF/2012/08/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Fri, 11 May :49:14 GMT) CTRI Number Last Modified On 03/05/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/05/ [Registered on: 06/05/2013] - Trial Registered Retrospectively No Interventional Vaccine Randomized, Parallel Group Trial Phase III study for evaluation of safety and efficacy of Varicella vaccine. An Open label, Phase III, Multicentric Randomized controlled study to evaluate the safety and immunogenicity of Single dose Live Attenuated Varicella Vaccine (VR 795 varicella Oka strain) versus Varilrix Vaccine in healthy n children Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) WOC/VAC/VAR/CT 19 PRT Protocol Number Details of Principal Investigator Mumbai Details Contact Person (Scientific Query) Details Contact Person (Public 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 Details of Ethics Committee > Type of Sponsor NIL List of Countries of Principal Investigator Dr Raju Shah Dr Apurba Ghosh Dr Nitin Shah Prof MMA Faridi Source of Monetary or Material Support Primary Sponsor Details, Wockhardt Towers, Bandra Kurla Complex, Bandra East, Mumbai Pharmaceutical industry-n NIL of Site Site // Ankur Children Hospital, Amedabad Department of pediatrics Ankur Children Hospital Behind City Gold Cinema, Ashram Road Navarangpura, Amedabad, Gujarat Ahmadabad GUJARAT Institute of Child Health Department of pediatrics 11 Biresh Guha Road, Kolkata Kolkata WEST BENGAL Lions Tara Chand Bapa Hospital, Mumbai University College of Medical Sciences & GTB Hospital Department of Pediatrics Lions Tara Chand Bapa Hospital, Sion (West), Mumbai: Mumbai Professor Department of Paediatrics University College of Medical Sciences & GTB Hospital Dilshad Garden, East Delhi, New Delhi New Delhi DELHI om om m m of Committee Approval Status Date of Approval Is Independent Ethics Committee? Academic & Ethical Committee GTB Delhi Dr MMA Faridi Aditya IEC - Ahmedabad Dr Nitin Approved 18/12/2012 No Approved 03/07/2012 Yes page 2 / 5

3 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Shah Aditya IEC - Ahmedabad Dr Raju Shah EC ICH Kolkata Dr Apurba Ghosh Status Approved 03/07/2012 Yes Approved 03/07/2012 No Date Approved/Obtained 09/08/2012 Health Type Healthy Human Volunteers Condition seronegative for Varicella Zoster Virus IgG antibody Type Details Intervention Comparator Agent Age From Age To Gender Details Single dose Live Attenuated Varicella Vaccine (VR 795 varicella Oka strain)of VARILRIX Manufactured by GSK Month(s) Year(s) Both Inclusion Criteria Live attenuated Varicella Vaccine VR 795 Varicella Oka strain. Single dose of 0.5 ml of reconstituted vaccine given subcutaneously. VARILRIX, a commercially approved live weakened varicella-zoster virus (Oka strain) manufactured by GSK. Single dose of 0.5ml varilrix vaccine given subcutaneously Healthy children aged 12 months to 12 years of either sex who are baseline VZV IgG antibody negative Parent/guardian of subject willing to give written informed consent and to comply to all study related procedures Exclusion Criteria Details Exclusion Criteria Clinical history of varicella (chicken pox) and herpes zoster natural infection in the past. History of Varicalla vaccination in the past. History of household, playmate, school or daycare center exposure to varicella or herpes zoster in the previous 4 weeks prior to vaccination Presence of any person in close vicinity of the vaccine who is at high risk of developing varicella (like immunocompromised sibling) Any established or clinically suspected immunosuppressive or immunocompromised disorder / state (congenital or acquired- drug induced, neoplastic, tuberculosis etc) Any subject who had received parenteral immunoglobulin or any immunosuppressive drugs in the last three months. Any major congenital abnormality cardiac, renal, neurological Any acute dermatological disease such as, allergy and bacterial/viral/ fungal infection Participant on any dose of oral/parenteral steroids or inhalational steroids >800 mcg of beclomethasone (or its equivalent) in the last 3 months prior to vaccination. History of any allergic diatheses and those with known hypersensitivity to vaccine or any of its components like gelatin, gentamicin / neomycin/ kanamycin etc. page 3 / 5

4 Febrile (axillary temperature > 37 C) or any systemic illness at the time of vaccination. History of administration of varicella zoster immune globulin or any blood products in the previous 4 weeks Subject has received any live vaccine in the last 4 weeks or any killed vaccine in the last 4 weeks prior to this scheduled vaccination. Subject scheduled to be administered a live vaccine in the next 4 weeks or any killed vaccine in the next 4 weeks. Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Case Record Numbers Open Label Primary Outcome Outcome Timepoints The immunogenicity profile of the test will be a. Seroconversion rates amongst those who evaluated and compared with that of the were baseline seronegative for IgG VZV reference (Varilrix) vaccine in the study antibody (i.e 100mIU/ml) and had a 6 weeks population by estimation of the: post-vaccination ELISA varicella IgG antibody a) Seroconversion rates amongst those who level of ( 150mIU/ml) were baseline seronegative for IgG VZV b. Extent of rise of Varicella (VZV) IgG antibody antibody (i.e 100mIU/ml) and had a 6 weeks from baseline values at 6 weeks post vaccination post-vaccination ELISA varicella IgG antibody level of ( 150mIU/ml) b) Extent of rise of Varicella (VZV) IgG antibody from baseline values at 6 weeks post vaccination Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 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 The safety of the vaccine in the study population will be evaluated by estimation of incidence of both serious and non-serious adverse events upto 6 weeks post vaccination with an intensive initial monitoring phase of 10 days post vaccination Total Sample Size=254 Sample Size from =254 05/09/2012 No Date Specified Years=0 Months=6 Days=0 Not Applicable Completed estimation of incidence of both serious and non-serious adverse events This is an An open label, Phase III, Multicentric, randomized controlled study to evaluate the safety and immunogenicity of Single dose Live Attenuated Varicella Vaccine (VR 795 of varicella Oka strain) Versus Varilrix Vaccine in healthy n children. There will be 268 subjects to be enrolled (134 in each arm) in this trial. THe objective of this trial is Comparative assessment of the immunogenicity of the test vaccine versus the comparator by estimation of: page 4 / 5

5 Powered by TCPDF ( REF/2012/08/ a) Seroconversion rates in each treatment arm at 6 weeks post vaccination. b) Extent of rise of Varicella (VZV) IgG antibody from baseline values at 6 weeks post vaccination. And comparative assessment of safety and tolerability of the vaccine up to 6 weeks post vaccination page 5 / 5