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CTRI Number  CTRI/2021/11/038282 [Registered on: 26/11/2021] Trial Registered Prospectively
Last Modified On: 06/07/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to evaluate the immunogenicity and safety of Quadrivalent seasonal influenza vaccine. 
Scientific Title of Study   A phase-III, randomized, double-blind, active-controlled, multi-center, clinical trial to evaluate the immunogenicity and safety of Quadrivalent seasonal influenza virus-like particle (VLP) vaccine of Cadila Pharmaceuticals Limited, India, in healthy human population. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CRSC20002 version 03 dated 17.09.2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anil Avhad 
Designation  Head - Cadila CRO 
Affiliation  Cadila Pharmaceuticals Limited 
Address  1389, Trasad Road Dholka, Ahmedabad
Dholka, Ahmedabad
Ahmadabad
GUJARAT
382225
India 
Phone  02714221481  
Fax    
Email  anil.avhad@cadilapharma.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Patel 
Designation  Asst. General Manager 
Affiliation  Cadila Pharmaceuticals Limited 
Address  1389, Trasad Road Dholka, Ahmedabad
1389, Trasad Road Dholka, Ahmedabad
Ahmadabad
GUJARAT
382225
India 
Phone  02714221481  
Fax    
Email  sanjay.p@cadilapharma.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Seema Sharma 
Designation  Assistant Vice President-CPL Biologics 
Affiliation  Cadila Pharmaceuticals Limited 
Address  1389, Trasad Road Dholka, Ahmedabad
1389, Trasad Road Dholka, Ahmedabad
Ahmadabad
GUJARAT
382225
India 
Phone  02714221481  
Fax    
Email  seema.sharma@cadilapharma.co.in  
 
Source of Monetary or Material Support  
Cadila Pharmaceuticals Limited. 1389, Trasad road, Dholka, Ahmedabad, India. 
 
Primary Sponsor  
Name  Cadila Pharmaceuticals Limited 
Address  Cadila Pharmaceuticals Limited. 1389, Trasad road, Dholka, Ahmedabad- 382225, Gujarat India. 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Atul Jindal  AII India Institute of Medical Sciences, Raipur  Department of Paediatric Medicine, Room No 1111, First Floor, Medical College Complex, Gate No 05, Great Eastern Rd, AIIMS Campus, Tatibandh, 492099
Raipur
CHHATTISGARH 		 8224014667

dratuljindal@mail.com 
Dr Nitin Agarwala  Downtown Hospital  Department of Pediatrics GS Rd, Bormotoria, - 781006
Kamrup
ASSAM 		 9864206868

nitindoc2000@gmail.com 
Dr Amit Saxena  Dr. DY Patil Hospital & Research Centre  Department of pediatrics, 11, Ayyappa Rd, Dr. D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai, Maharashtra – 400706. India.
Mumbai
MAHARASHTRA 		 9619164465

dramitsaxena1981@gmail.com 
Dr Sushant Mane  Grant Govt. Medical College & Sir JJ Groups of Hospitals  Department of Paediatric Byculla, Mumbai, 400008
Mumbai
MAHARASHTRA 		 9820864049

drsush2006@gmail.com 
Dr Khusboo Patel  HCC Happiness Care and Cure Multispecialty Hospital LLP  Shivranjani Cross Road, Ahmedabad 380015, Gujarat. India.
Ahmadabad
GUJARAT 		 9998939051

drkhusboo.cr@gmail.com 
Dr A Ramanath  Panimalar Medical College Hospital & Research Institute  Department of Paediatrics Varadharajapuram, Poonamallee, - 600 123
Chennai
TAMIL NADU 		 9884750160

Chandra.ramanath82@gmail.com 
Dr Gaurav Anupraj Sharma  Priyadarshani Nursing Home  201-208, Department of Medicine, M-Bari Estate, Kargil Nagar Road, Opp Manvel Pada, Talav, Virar (East), Palghar-401303. Maharashtra.
Mumbai
MAHARASHTRA 		 9822886688

gauranup2@gmail.com 
Dr Shyam Narain Gupta  Sanjivani Hospital and Research Center  CP-23, Viraj khand, near hahnemann Chauraha, Gomti Nagar, Lucknow - 226010.UP
Lucknow
UTTAR PRADESH 		 9415007110

smsdgupta@gmail.com 
Dr Surendra Kumar  Sardar Patel Medical College & AG Hospital, P.B.M. Hospital  Ground Floor Near Medicine ICU. Bikaner. Rajasthan-334001.India.
Bikaner
RAJASTHAN 		 9414604192

drsurendrakumar@rediffmail.com 
Dr Paresh Thakkar  SSG Hospital  Department of Paediatric Medical College & SSG Hospital Jail Rd, Indira Avenue, Baroda 390001
Vadodara
GUJARAT 		 9426032150

pareshthakkar@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Ethics Committee, S.P. Medical college, Bikaner  Approved 
Institutional Ethics Committee, AIIMS Raipur  Approved 
Institutional Ethics Committee, D Y Patil Medical college  Approved 
Institutional Ethics Committee, Downtown Hospital  Approved 
Institutional Ethics Committee, Grant Govt. Medical College & Sir JJ Groups of Hospitals  Approved 
Institutional Ethics Committee, New Healthcare Nursing Home, Priyadarshini nursing home  Approved 
Institutional Ethics Committee, Panimalar Medical College  Approved 
Institutional Ethics Committee, SSG Hospital  Approved 
Parth Institutional Ethics Committee  Approved 
Sanjivani Lung Centre Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy pediatric and adult population 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Influvac Tetra Inactivated Influenza Vaccine (surface antigen) I.P. (Quadrivalent) of Abbott India Limited  Intramuscular (IM) injection of 0.5 ml, One dose for 9 to 65 year and Two dose for 6 month to 8 year 
Intervention  Quadrivalent seasonal Influenza VLP Vaccine, manufactured by Cadila Pharmaceuticals Limited, India  Intramuscular (IM) injection of 0.5 ml, One dose for 9 to 65 year and Two dose for 6 month to 8 year 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Healthy subjects of either gender, with more than 6 month (included) to ≤65 years of age with no prior history of influenza vaccination.
2.Subjects who are in good health at the time of randomization into the study.
3.For subjects aged 6 to 35 months only: born at full term of pregnancy (>37
weeks) or birth weight >2.5 kg or both.
4.Subject, subject’s parent(s) or LAR(s) agrees to comply with protocol requirements and able to sign and date a written, ICF and assent form.
5.Documented negative test for human immunodeficiency virus (HIV-1/2),HBsAg or HCV.
6.Female subject with negative Urine pregnancy test. 
 
ExclusionCriteria 
Details  1.Any condition determined likely to interfere with evaluation of the vaccine or having potential health risk to the subject or make it unlikely that the subject would complete the study.
2.Subjects with history of administration of any influenza vaccine or subjects with laboratory confirmed influenza in past one year.
3.Screening serum transaminase or alkaline phosphatase, creatinine and total bilirubin >1.5 times of ULN.
4.History of hypersensitivity to any component of the vaccines.
5.Any known immunocompromising condition or immunosuppressive therapy within 6 months preceding enrolment.
6.History of any use of systemic glucocorticoids and influenza antiviral medication.
7.History of underlying medical conditions, seizures or any progressive neurological disease, any congenital abnormalities, including hemoglobinopathies.
8.Children and adolescents receiving aspirin- or salicylate-containing medications and who might be at risk for experiencing Reye syndrome after influenza virus infection.
9.History of multiple sclerosis, lupus, Guillain-Barré syndrome, thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy.
10.Immunocompromised subjects
11.Subjects administered blood, blood containing products or Immunoglobulins within the last 3 months or planned administration during the study.
12.Any other vaccine administration within the last 30 days or planned to be administered during the study period.
13.Documented fever of > 100.4 °F or above as axillary temperature in the preceding 14 days before screening.
14.Pregnant and lactating girls and female subjects of child bearing age not using acceptable contraceptive measures.
15.Participation in another clinical trial during past 3 month prior to screening 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Quadrivalent Seasonal Influenza VLP vaccine of Cadila Pharmaceuticals Limited, India based on HI antibody response for at least one of the criteria i.e. seroconversion rate, seroprotection rate and increase in geometric mean HI titer.  28 days after last vaccination for all age groups 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the safety and tolerability of study vaccines.  Solicited AE: 7 days after vaccination for all age groups
Unsolicited AE: 28 days after vaccination for all age groups 
Comparison of Immunogenicity results between test and reference vaccine for all four vaccine strains  28 days after last vaccination for all age group 
 
Target Sample Size   Total Sample Size="660"
Sample Size from India="660" 
Final Enrollment numbers achieved (Total)= "660"
Final Enrollment numbers achieved (India)="660" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 30/11/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
This is a phase-III, prospective, randomized, double-blind, active-controlled, parallel, multicentric, clinical trial to evaluate the immunogenicity and safety of Quadrivalent Seasonal Influenza VLP Vaccine in healthy pediatric and adult population of different age groups.
 
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