CTRI Number	CTRI/2014/06/004707 [Registered on: 26/06/2014] Trial Registered Prospectively
Last Modified On:	13/12/2014
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Vaccine
Study Design	Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study Modification(s)	A study to test the safety of a new H1N1 influenza vaccine in healthy volunteers
Scientific Title of Study	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 Modification(s)	Secondary ID  Registry  CRSC13001; Version-01, Protocol Amendment, Date 06/07/13  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr Deepak Sawhney  Address  1389, Trasad Road, Dholka, Ahmedabad Ahmadabad GUJARAT 387810 India  Phone  02714-221481   Fax     Email  deepak.sawhney@cadilapharma.co.in
Details Contact Person Scientific Query	Name  Dr Deepak Sawhney  Address  1389, Trasad Road, Dholka, Ahmedabad GUJARAT 387810 India  Phone  02714-221481   Fax     Email  deepak.sawhney@cadilapharma.co.in
Details Contact Person Public Query	Name  Dr Deepak Sawhney  Address  1389, Trasad Road, Dholka, Ahmedabad GUJARAT 387810 India  Phone  02714-221481   Fax     Email  deepak.sawhney@cadilapharma.co.in
Source of Monetary or Material Support	Cadila Pharmaceuticals Limited
Primary Sponsor	Name  Cadila Pharmaceuticals Limited  Address  Corporate Campus, Sarkhej-Dholka Highway, Village: Bhat, Ahmedabad – 382210, Gujarat, India.  Type of Sponsor  Pharmaceutical industry-Indian
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 12   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr SK Sharma  All India Institute of Medical  Department of Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029 New Delhi   011-26594415 sksharma@aiims.ac.in  Dr Sanjeev Rao  Apollo – BGS Hospitals  Dept of Medicine, Adichunchanagiri Road, Kuvempunagar, Mysore – 570023, Karnataka, India Mysore   9986051595 srgdec4@gmail.com  Dr Ahrar Ahmed  Apollo DRDO Hospital  Dept of Medicine, DMRL Cross Roads, Kanchan Bagh, Hyderabad-500058, Andhra Pradesh Hyderabad   040-24342222 dr_aaf@yahoo.co.in  Dr Pitambar Prusty  Apollo Hospitals  Dept. of Medicine, A unit of Apollo Hospitals Enterprises Limited, Bhubaneswar – 751005, Orissa, India Khordha   8093060134 prustypita@rediffmail.com  Dr Venkatasubramanian Ramasubramanian  Apollo Hospitals  Room No 16 & 17, 2nd floor, Krishnadeep Chambers, Greams Lane, Off Greams road, Chennai-600006, Tamil Nadu, India Chennai   044-28295045 idisdoc@gmail.com  Dr Manoj Singh  Apollo Hospitals International Limited  Dept. of medicine, Bhat, GIDC Estate, Gandhinagar – 382 428, Gujarat, India. Gandhinagar   079-66701800 drmanojsingh@rediffmail.com  Dr Asha Shah  B.J. Medical College  Dept. of Medicine, Civil Hospital, Ahmedabad- 380016, Gujarat, India Ahmadabad   079-22983721 ashashah55@gmail.com  Dr Alok Aggrawal  Indraprastha Apollo Hospitals  Dept of Medicine, Sarita Vihar, Delhi-Mathura Road, New Delhi-110076 New Delhi   011-26925825 aloc_doc2003@hotmail.com  Dr Ashish Bavdekar  KEM Hospital Research Centre,  Dept of Medicine, KEM Hospital Research Centre, Sardar Moodlier Road, Rasta Peth, Pune-411011, Maharashtra, India Pune   020-66037342 kemhre@vsnl.net  DrSatyabrata Ganguly  Medical College  Department of Medicine, Medical College, #88, College Street, Kolkata-700073 West Bengal, India Kolkata   033-22414901 dr_satyaganguly@yahoo.co.in  DrSurendra Kumar  Sardar Patel Medical College and P.B.M hospital  Dept of Medicine, Sardar Patel Medical College and P.B.M hospital, Bikaner-334003, Rajasthan, India Bikaner   0151-2226334 drsurendrakumar@rediffmail.com  Dr Nithya Gogtay  Seth GS Medical College & KEM Hospital  Department of Clinical Pharmacology, Seth GS Medical College & KEM Hospital, Parel, Mumbai-400012, Maharashtra, India Mumbai   022-24133767 njgogtay@hotmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 11   Name of Committee  Approval Status  Ethics comittee KEM hospital research centre Pune  Approved  Ethics comittee on clinical trial Apollo Hospital Delhi  Approved  Ethics comittee S P medical college and hospitals  Approved  Ethics Committee Apollo hospitals Bhubaneswar  Submittted/Under Review  Ethics Committee Apollo hospitals Chennai  Submittted/Under Review  Ethics Committee Apollo hospitals international limited Gandhinagar  Approved  Ethics Committee Apollo hospitals international limited Hyderabad  Approved  Ethics Committee Apollo hospitals Mysore  Approved  Ethics Committee Seth GS Medical College & KEM Hospital Mumbai  Submittted/Under Review  Institutite Ethics Committe AIIMS New Delhi  Submittted/Under Review  The Institutional Ethics committee B J Medical college & civil hospital ahmedabad  Approved
Regulatory Clearance Status from DCGI	Status  Approved/Obtained
Health Condition / Problems Studied	Health Type  Condition  Healthy Human Volunteers  H1N1 Influenza
Intervention / Comparator Agent Modification(s)	Type  Name  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)
Inclusion Criteria	Age From  18.00 Year(s) Age To  64.00 Year(s) Gender  Both  Details  •Healthy volunteers of either sex between 18-64 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.
ExclusionCriteria	Details  •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 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 ³100.5 0F •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	Computer generated randomization
Method of Concealment	Pharmacy-controlled Randomization
Blinding/Masking	Participant and Investigator Blinded
Primary Outcome	Outcome  TimePoints  immunogenicity of H1N1-09 influenza VLP vaccine  Seroconversion rate (Time frame: 22 days post-vaccination) Seroprotection rate (Time frame: 22 days post-vaccination) Mean fold-rise (Time frame: 22 days post-vaccination)
Secondary Outcome	Outcome  TimePoints  safety and tolerability of H1N1-09 influenza VLP vaccine   Solicited adverse events (Time frame: 7 days post-vaccination)  Unsolicited adverse events (Time frame: 22 days post-vaccination)
Target Sample Size	Total Sample Size="450" Sample Size from India="450"
Phase of Trial	Phase 3
Date of First Enrollment (India) Modification(s)	01/07/2014
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details	NIL
Brief Summary	Cadila Pharmaceuticals Limited, India has successfully tested VLP-based H1N1-09 pandemic influenza vaccine in preclinical models and phase-I/II study (2012-2013). 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 India