CTRI Number	CTRI/2014/10/005107 [Registered on: 15/10/2014] Trial Registered Retrospectively
Last Modified On:	10/04/2021
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 trivalent seasonal influenza vaccine in healthy volunteers
Scientific Title of Study	A Randomized, Double-blind, Placebo-controlled, Clinical Trial to Evaluate the Immunogenicity and Safety of Trivalent seasonal Influenza Virus-Like Particle (VLP) Vaccine
Secondary IDs if Any	Secondary ID  Registry  CRSC13003; Version-01, date 18/09/13   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 = 10   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr SKSharma  All india Institute Of Medical Science  Department Of Medicine,All India Institute Of Medical Science,Ansari Nagar,New Delhi-110029 New Delhi   011-26594415 sksharma@aiims.ac.in  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 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 Amitav Mohanty  Apollo Hospitals Bhubaneswar  Plot No-251,Sainik School Road,Unit-15,Bhubaneswar-751005,Odisha,India Khordha   91-6746660408 dramitav_m@apollohospitals.com  Dr Manoj Singh   Apollo Hospitals International Limited   Dept of Medicine, Bhat, GIDC Estate, Gandhinagar – 382 428, Gujarat, India. Gandhinagar GUJARAT 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 Siddharth Deshpande  Department Of Pharmacology,Seth GSMC & KEMH  1st Floor,MS Building,Seth GSMC & KEMH,Acharya Donde Marg Parel-400012,Mumbai Mumbai   022-24133767 sidds90@yahoo.com  Dr Alok Aggrawal   Indraprastha Apollo Hospitals  Dept of Medicine, Sarita Vihar, Delhi-Mathura Road, New Delhi-110076 New Delhi   011-26925825 alok_doc2003@hotmail.com  Dr Pradeep Dcosta  KEM Hospital Research Centre,  Dept of Medicine, KEM Hospital Research Centre, Sardar Moodlier Road, Rasta Peth, Pune-411011, Maharashtra, India Pune   020-66037342 kemhrc@vsnl.net  Dr Surendra 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
Details of Ethics Committee Modification(s)	No of Ethics Committees= 8   Name of Committee  Approval Status  Ethics comittee KEM hospital research centre Pune  Approved  Ethics comittee on clinical trial Apollo Hospital Chennai  Approved  Ethics comittee on clinical trial Apollo Hospital Delhi   Approved  Ethics comittee S P medical college and hospitals Bikaner  Approved  Ethics Committee Apollo hospitals international limited Gandhinagar  Submittted/Under Review  Ethics Committee Apollo hospitals international limited Hyderabad  Approved  Ethics committee of AIIMS hopsital  Approved  The Institutional Ethics committee B J Medical college & civil hospital ahmedabad   Approved
Regulatory Clearance Status from DCGI	Status  Approved/Obtained
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Healthy Human Volunteers  Seasonal Influenza
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Comparator Agent  Placebo  0.5 ml Intramuscular Injection once on day 0   Intervention  Trivalent seasonal Influenza Virus-Like Particle (VLP) Vaccine  0.5 ml Intramuscular injection of Trivalent seasonal Influenza Virus-Like Particle (VLP) Vaccine once on Day 0
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 ≥100.5 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 •History of Congenital or acquired immunodeficiency, or of 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 Trivalent Seasonal influenza VLP vaccine  Seroconversion rate (Time frame: 22 days post-vaccination) Seroprotection rate (Time frame: 22 days post-vaccination) Geometric Mean fold-rise (Time frame: 22 days post-vaccination)
Secondary Outcome	Outcome  TimePoints  safety and tolerability of Trivalent seasonal 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)	01/08/2014
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 trivalent seasonal influenza vaccine in preclinical models and phase-I/II study (2012-2013). Based on this, present study is the Phase-III trial involving trivalent seasonal influenza VLP Vaccine containing strains A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2) and B/Massachusetts/2/2012 to be conducted among larger population at multi centers across India in order to more fully describe the immune response and extend the safety database.