REF/2014/04/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Wed, 02 May :38:55 GMT) CTRI Number Last Modified On 13/12/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2014/06/ [Registered on: 26/06/2014] - Trial Registered Prospectively Interventional Vaccine Randomized, Parallel Group, Placebo Controlled Trial A study to test the safety of a new H1N1 influenza vaccine in healthy volunteers A Randomized, Double-blind, Placebo-controlled, Clinical Trial to Evaluate the Immunogenicity and Safety of H1N1-09 Influenza Virus-Like Particle (VLP) Vaccine Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) CRSC13001; Version-01, Protocol Amendment, Date 06/07/13 Designation Affiliation Protocol Number Details of Principal Investigator Dr Deepak Sawhney Head BA/BE & CR Phone Fax Designation Affiliation 1389, Trasad Road, Dholka, Ahmedabad Ahmadabad deepak.sawhney@cadilapharma.co.in Details Contact Person (Scientific Query) Dr Deepak Sawhney Head BA/BE & CR 1389, Trasad Road, Dholka, Ahmedabad Details Contact Person (Public Query) Phone Fax Designation Affiliation deepak.sawhney@cadilapharma.co.in Details Contact Person (Public Query) Dr Deepak Sawhney Head BA/BE & CR 1389, Trasad Road, Dholka, Ahmedabad Phone Fax deepak.sawhney@cadilapharma.co.in page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study > Type of Sponsor NIL List of Countries of Principal Investigator Dr SK Sharma Dr Sanjeev Rao Source of Monetary or Material Support Primary Sponsor Details Corporate Campus, Sarkhej-Dholka Highway, Village: Bhat, Ahmedabad , Gujarat,. Pharmaceutical industry-n NIL of Site Site Phone/Fax/ All Institute of Medical Department of Medicine, All Institute of Medical Sciences, Ansari Nagar, New Delhi New Delhi DELHI Apollo BGS Hospitals Dept of Medicine, Adichunchanagiri Road, Kuvempunagar, Mysore , Karnataka, Mysore KARNATAKA Dr Ahrar Ahmed Apollo DRDO Hospital Dept of Medicine, DMRL Cross Roads, Kanchan Bagh, Hyderabad , Andhra Pradesh Hyderabad ANDHRA PRADESH Dr Pitambar Prusty Apollo Hospitals Dept. of Medicine, A unit of Apollo Hospitals Enterprises Limited, Bhubaneswar , Orissa, Khordha ORISSA Dr Venkatasubramanian Ramasubramanian Dr Manoj Singh Apollo Hospitals Apollo Hospitals International Limited Room 16 & 17, 2nd floor, Krishnadeep Chambers, Greams Lane, Off Greams road, Chennai , Tamil Nadu, Chennai TAMIL NADU Dept. of medicine, Bhat, GIDC Estate, Gandhinagar , Gujarat,. Gandhinagar dr_aaf@yahoo.co.in prustypita@rediffmail.c om idisdoc@gmail.com drmanojsingh@rediffma il.com page 2 / 6

3 Details of Ethics Committee Dr Asha Shah B.J. Medical College Dept. of Medicine, Civil Hospital, Ahmedabad , Gujarat, Ahmadabad Dr Alok Aggrawal Dr Ashish Bavdekar Indraprastha Apollo Hospitals KEM Hospital Research Centre, Dept of Medicine, Sarita Vihar, Delhi-Mathura Road, New Delhi New Delhi DELHI m Dept of Medicine, KEM Hospital Research Centre, Sardar Moodlier Road, Rasta Peth, Pune , Maharashtra, Pune MAHARASHTRA DrSatyabrata Ganguly Medical College Department of Medicine, Medical College, #88, College Street, Kolkata West Bengal, Kolkata WEST BENGAL DrSurendra Kumar Dr Nithya Gogtay Sardar Patel Medical College and P.B.M hospital Dept of Medicine, Sardar Patel Medical College and P.B.M hospital, Bikaner , Rajasthan, Bikaner RAJASTHAN Seth GS Medical Department of Clinical College & KEM Hospital Pharmacology, Seth GS Medical College & KEM Hospital, Parel, Mumbai , Maharashtra, Mumbai MAHARASHTRA o.co.in fmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics comittee KEM Approved 07/10/2013 hospital research centre Pune Ethics comittee on clinical trial Apollo Hospital Delhi Ethics comittee S P medical college and hospitals Ethics Committee Bhubaneswar Approved 15/11/2013 Approved 16/11/2013 Submittted/Under Date Specified Ethics Committee Submittted/Under Date Specified page 3 / 6

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Chennai Ethics Committee international limited Gandhinagar Ethics Committee international limited Hyderabad Approved 16/05/2013 Approved 10/10/2013 Ethics Committee Approved 02/07/2013 Mysore Ethics Committee Seth GS Medical College & KEM Hospital Mumbai Institutite Ethics Committe AIIMS New Delhi The Institutional Ethics committee B J Medical college & civil hospital ahmedabad Status Submittted/Under Submittted/Under Date Specified Date Specified Approved 06/02/2014 Date Approved/Obtained 02/04/2014 Health Type Healthy Human Volunteers Condition H1N1 Influenza Type Details Intervention H1N1-09 Influenza Virus-Like Particle (VLP) Vaccine 0.5 ml Intramuscular injection of H1N1-09 influenza VLP vaccine (15µg HA of A/California/04/2009/H1N1) on Day 0 (SINGLE DOSE) Comparator Agent Placebo 0.5 ml Intramuscular Injection on day 0 (SINGLE DOSE) Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria Healthy volunteers of either sex between years of age, inclusive Informed consent must be obtained from the volunteer prior to beginning any study specific procedures indicating that they understand the purpose of this study and are willing to adhere to the procedures described in this protocol. Exclusion Criteria Details Exclusion Criteria Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period Receipt of any other licensed influenza vaccines or investigational influenza vaccine within 6 months prior to enrollment in this study or page 4 / 6

5 expected receipt of any vaccination before the final immune response blood collection History of hypersensitivity to any component of inactivated influenza vaccines Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within six months prior to the administration of the study vaccine (inhaled & topical steroids are allowed) Use of systemic glucocorticoids within one month prior to randomization Any clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by history, physical examination or laboratory screening tests Screening serum transaminase or alkaline phosphatase more than 3 times of ULN, creatinine and total bilirubin 1.5 times of ULN, Hgb 10 gm/dl, or BMI 28? Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination Administration of immunoglobulin and/or any blood products within the three months preceding the administration of the study vaccine or during the study Acute illness of moderate or severe intensity at the time of enrollment, including any illness associated with fever ³ F Any congenital abnormalities, including hemglobinopathies, which could increase the risk of influenza complications History of any neurological disorders or seizures (with the exception of febrile seizures during childhood) related to an underlying immune disease or disorder, such as but not limited to: multiple sclerosis, lupus, Guillain-Barre syndrome. Women who are found to have a positive urinary pregnancy test; pregnant or lactating history or physical examination, or planning to become pregnant or to discontinue contraceptive precautions within 60 days of enrollment in this study Volunteers found positive in drugs of abuse test Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months Any condition that in the opinion of the investigator would interfere with evaluation of the vaccine or interpretation of study results Method of Generating Random Sequence Method of Concealment Computer generated randomization Pharmacy-controlled Randomization page 5 / 6

6 Powered by TCPDF ( REF/2014/04/ Blinding/Masking Participant and Investigator Blinded Primary Outcome Outcome Timepoints immunogenicity of H1N1-09 influenza VLP vaccine Seroconversion rate (Time frame: 22 days Seroprotection rate (Time frame: 22 days Mean fold-rise (Time frame: 22 days Secondary Outcome Outcome Timepoints safety and tolerability of H1N1-09 influenza VLP vaccine? Solicited adverse events (Time frame: 7 days? Unsolicited adverse events (Time frame: 22 days 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 Total Sample Size=450 Sample Size from =450 01/07/2014 Date Specified Years=0 Months=6 Days=0 t Applicable Completed NIL, has successfully tested VLP-based H1N1-09 pandemic influenza vaccine in preclinical models and phase-i/ii study ( ). Based on this, present study is the Phase-III trial involving H1N1-09 influenza VLP Vaccine containing strain A/California/04/2009/H1N1 to be conducted among larger population at multicenters across page 6 / 6