| CTRI Number |
CTRI/2015/09/006209 [Registered on: 23/09/2015] Trial Registered Prospectively |
| Last Modified On: |
14/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study to compare the immune response and safety of tetravalent flu vaccine manufactured by Cadila Healthcare Ltd. with a trivalent flu vaccine marketed in India in healthy adults |
|
Scientific Title of Study
|
A prospective, randomized, two arm, single blind, parallel, active controlled, multicentre, phase II/III clinical study to evaluate the immunogenicity and safety of Inactivated Tetravalent Influenza vaccine (split virion) of M/s Cadila Healthcare Limited compared to marketed Inactivated Trivalent Influenza vaccine in healthy adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Project No.15-02; Version 00; dated 27-04-2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
Cadila Healthcare Ltd |
| Address |
Cadila Healthcare Ltd., Zydus-PTC, Sigma Commerce Zone, B/H ISCON Temple, Near Satellite Cross Roads, Ambli-Bopal Road
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868926 |
| Fax |
079-26868910 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
Cadila Healthcare Ltd |
| Address |
Cadila Healthcare Ltd., Zydus-PTC, Sigma Commerce Zone, B/H ISCON Temple, Near Satellite Cross Roads, Ambli-Bopal Road
GUJARAT
380015
India |
| Phone |
079-26868926 |
| Fax |
079-26868910 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Senior Manager – New Product Development |
| Affiliation |
Cadila Healthcare Ltd |
| Address |
Cadila Healthcare Ltd., Zydus-PTC, Sigma Commerce Zone, B/H ISCON Temple, Near Satellite Cross Roads, Ambli-Bopal Road, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868924 |
| Fax |
079-26868910 |
| Email |
jayeshsanmukhani@zyduscadila.com |
|
|
Source of Monetary or Material Support
|
| Cadila Healthcare Ltd., SIGMA CommerZone Near Iscon Temple & Satellite Cross Roads, Ambli-Bopal Road, Ahmedabad - 380015. Gujarat, INDIA. Phone No.: 079-2686-8900079-2686-8900 Fax No.: 079-2686-8910 |
|
|
Primary Sponsor
|
| Name |
Cadila Healthcare Ltd |
| Address |
SIGMA CommerZone Near Iscon Temple & Satellite Cross Roads, Ambli-Bopal Road, Ahmedabad - 380015. Gujarat, INDIA. Phone No.: 079-2686-8900079-2686-8900 Fax No.: 079-2686-8910 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kalpesh S Sukhwani |
GCS Medical College |
Department of Medicine
GCS Medical college, Hospital & Research Centre, Opp. DRM office, Nr. Chamunda bridge, naroda Road
Ahmadabad
GUJARAT |
8238268870
kalpesh1710@yahoo.com |
| Dr Sanjay Kumar Jangid |
Hi-Tech Medical College and Hospital |
Department of Medicine, Hi-Tech Medical College and Hospital, Health Park, Pandara, Rasulgarh, Bhubaneshwar
Khordha
ORISSA |
09337671521
drsanjay_jangid@yahoo.co.in |
| Dr Rajesh Vukkala |
Indo-US Super-speciality Hospital |
Room No. 2, Ground Floor, Indo-US Super-speciality Hospital, Shyam Karan Road, Ameerpet
Hyderabad
ANDHRA PRADESH |
7702116066
vukkala@gmail.com |
| Dr Jitendra Vinubhai Patel |
Medilink Hospital |
Research Room, Basement, Medilink Hospital, Near Shyamal Char-rasta,
132 ft. Ring Road, Satellite
Ahmadabad
GUJARAT |
079-26760646
medilinkresearchcentre@yahoo.com |
| Dr Sanjay Kumar |
MV Hospital And Research Centre |
314/13 ,Mirza Mandi, Chowk
Lucknow
UTTAR PRADESH |
0522-2258215
mvhrclko@gmail.com |
| Dr Veer Bahadur Singh |
S. P. Medical College and P.B.M Hospitals |
Department of Medicine, PBM Hospital
Bikaner
RAJASTHAN |
9414136888
vbsingh2@rediffmail.com |
| Dr Shrikant Sharma |
SMS Medical College & Hospital |
Department of Medicine,
SMS Medical College & Hospital,
JLN Marg, Jaipur
Jaipur
RAJASTHAN |
9214403945
skant_sunita@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethics Committee, S.P Medical College & A.G Hospitals Ethics Committee, S.P Medical College & A.G Hospitals HRMC Cardiovascular Sciences & Research Centre Bikaner 334001 |
Approved |
| Institutional Ethics Committee, 1st floor, MV Hospital And Research Centre, 314/13 ,Mirza Mandi, Chowk, Lucknow -226003 |
Approved |
| Institutional Ethics Committee, GCS Medical college, Hospital & Research Centre, Opp. DRM office, Nr. Chamunda bridge, naroda Road, Ahmedabad 25, Gujarat |
Approved |
| Institutional Ethics Committee, Hi-Tech Medical College & Hospital, Health Park, Pandra, Rasulgarh, Bhubaneswar, Odisha 751025 |
Approved |
| Institutional Ethics Committee, Indo-US Super-speciality Hospital, Shyam Karan Road, Ameerpet, Hyderabad-500016, Telangana |
Approved |
| Medilink Ethics Committee, Basement Medilink Hospital, Near Shyamal Char-rasta, 132 ft. Ring Road, Satellite, Ahmedabad-380015 |
Approved |
| The Ethics Committee, S.M.S. Medical College and Attached Hospitals, Jaipur First Floor, Dhanvantri OPD Block, S.M.S. Hospital, J.L.N. Marg, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Active immunization for the prevention of influenza |
| Patients |
(1) ICD-10 Condition: Z23||Encounter for immunization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inactivated Tetravalent Influenza vaccine (split virion) I.P. of M/s Cadila Healthcare Limited |
Each subject will be given a single dose of 0.5ml vaccine given as a intramuscular injection in the deltoid region on day 0. Subjects will be followed up for 42 days after single dose of vaccine |
| Comparator Agent |
Vaxigrip, Influenza vaccine (Split Virion, Inactivated) Manufactured by Sanofi Pasteur SA, (France) |
Each subject will be given a single dose of 0.5ml vaccine given as a intramuscular injection in the deltoid region on day 0. Subjects will be followed up for 42 days after single dose of vaccine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy subject of either gender ≥ 18 years of age
2. Written informed consent from subjects
3. Adult subjects literature enough to fill the diary card |
|
| ExclusionCriteria |
| Details |
1. Past history of hypersensitivity reaction, neurological disorder (Guillain–Barré syndrome or others) or any serious adverse event to any component of influenza vaccine, egg, chicken proteins, aminoglycoside antibiotics
2. Subjects with history of administration of any influenza vaccine within the past 6 months or subjects with laboratory confirmed influenza in past
3. Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
4. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
5. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
6. Subjects with febrile illness (temperature ≥ 100.4°F) at the time of enrolment, or acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy during the preceding 7 days
7. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
8. Any other vaccine administration within the last 30 days or planned to be administered during the study period
9. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
10. Participation in another clinical trial in the past 3 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Serologic parameters set by the Committee for Medicinal Products for Human Use (CHMP) for influenza vaccines
2. Seroconversion rate for all the four viral strains in the two groups at the end of study |
21 days following vaccination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Geometric mean titres for all the four viral strains in the two groups at the end of the study |
21 days following vaccination |
| Seroprotection rate for all the four viral strains in the two groups at the end of the study |
21 days following vaccination |
| Local and systemic adverse events reported during the study |
42 days following vaccination |
|
|
Target Sample Size
|
Total Sample Size="348"
Sample Size from India="348"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/09/2015 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized, single blind, parallel group,
multicentre, non-inferiority phase II/III clinical trial to evaluate the
immunogenicity and safety of Inactivated Tetravalent Influenza vaccine (split
virion) of M/s Cadila Healthcare Limited compared to Vaxigrip (Influenza
vaccine (Split Virion, Inactivated) Manufactured by Sanofi Pasteur SA, (France))
in healthy adults. Three hundred and forty eight subjects will be randomized to
receive either Inactivated Tetravalent Influenza vaccine (split virion) of M/s
Cadila Healthcare Limited or Vaxigrip (Influenza vaccine (Split Virion,
Inactivated) Manufactured by Sanofi Pasteur SA, (France)) according to the
centralized computer generated randomization plan. A pre vaccination and a post
vaccination (day 21) blood sample will be collected to determine antibody
titres attained after vaccination using haemaglutination inhibition assay against
the vaccine strains of A/H1N1, A/H3N2, B/Victoria and B/Yamagata. Assessment of
vaccine shall be based on the serologic parameters set by the Committee for
Medicinal Products for Human Use (CHMP) for influenza vaccines. The end points
for the study are Seroconversion rate, Seroprotection rate and Geometric Mean Titres
for all the four viral strains in the two groups at the end of study. The
results will also be stratified by age groups (adults: ≥18 to 60 years; and
elderly: >60 years). The safety of the vaccine will be assessed by recording
the adverse events occurring during the entire course of the study (42 days) |