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
|
|
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
|
|
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. |