| CTRI Number |
CTRI/2017/08/009204 [Registered on: 01/08/2017] 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 evaluate the immune response and safety of four valent flu vaccine manufactured by Cadila Healthcare Ltd. in healthy children aged 6 months to 17 years |
|
Scientific Title of Study
|
A prospective, randomized, two arm, single
blind, parallel, active controlled, multicentre,
phase III clinical study to evaluate the
immunogenicity and safety of Inactivated
Influenza vaccine (split virion) I.P.
(Tetravalent) of M/s Cadila Healthcare
Limited in healthy children aged 6 months to
17 years |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Project No.16-05; Version 01; dated 08-03-2017 |
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 |
07926868926 |
| Fax |
|
| 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
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
|
| 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 |
7600012192 |
| Fax |
|
| 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 = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chandrakant Bokade |
Government Medical college and Hospital |
HOD Room, Department of Paediatrics, 1st Floor
Nagpur
Nagpur
MAHARASHTRA |
9373111532
cmbokade77@gmail.com |
| Dr Sumantra Sarkar |
IPGMER & SSKM Hospital |
Department of Pediatrics, IPGMER & SSKM Hospital, A.J.C. Bose Road
Kolkata
WEST BENGAL |
9433090390
drsumantrasarkar@gmail.com |
| Dr N Ravi Kumar |
Niloufer Hospital (Osmania Medical College) |
Research Room, First Floor, Niloufer Hospital (OPD Building), Lakdikapol
Hyderabad
ANDHRA PRADESH |
9392393394
ravik1961@yahoo.com |
| Dr Kapil Garg |
SMS Medical College |
Professors chamber (Dr. Kapil Garg), 3rd Floor,Jay Kay Lon Hospital
Jaipur
RAJASTHAN |
01412619827
drkapilgargjkl@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee, Osmania medical College, Koti, Hyderabad – 500059 |
Approved |
| Institutional Ethics Committee, Department of Pharmacology, Government Medical College, Nagpur – 440003, Maharashtra |
Approved |
| IPGME & R Research Oversight Committee, Institute of Post Graduate Medical Education and Research (IPGME & R) 244, AJC Bose Road, Kolkata-700020 |
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 |
| Comparator Agent |
Inactivated Influenza vaccine
(split virion) I.P. of M/s Sanofi Pasteur |
Subjects enrolled in Cohort 1 (9 – 17 years) will receive 0.5 ml single dose. Subjects enrolled in Cohort 2 (3 – 8 years) will receive two doses (0.5 ml each, at least 28 days apart) subjects in Cohort 3 (6-35 months) will receive 2 doses (0.25 ml each, at least 28 days apart) |
| Intervention |
Inactivated Tetravalent Influenza vaccine (split virion) I.P. of M/s Cadila Healthcare Limited |
Subjects enrolled in Cohort 1 (9 – 17 years) will receive 0.5 ml single dose.
Subjects enrolled in Cohort 2 (3 – 8 years) will receive two doses (0.5 ml each, at
least 28 days apart)
subjects in Cohort 3 (6-35 months) will receive
2 doses (0.25 ml each, at least 28 days apart) |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy subject of either gender 6 months to 17 years of age
2. Written informed consent from subject’s either parent (mother / father) and
written assent from subjects more than 7 years of age
3. Subject’s either parent (mother / father) literate 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 vaccine, egg,
chicken proteins, aminoglycoside antibiotics
2. Subjects with history of administration of any influenza vaccine 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 ≥ 37.5°C) 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 girls & female subjects of child bearing age 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 |
Fulfilment of serologic criteria set by the USFDA for licensure of seasonal
inactivated Influenza vaccines in pediatric population in Test group |
28 days after
last vaccination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Seroprotection rate for all the four viral strains in the two groups, 28 days after
last vaccination |
28 days after
last vaccination |
Seroconversion rate for all the four viral strains in the two groups, 28 days
after last vaccination |
28 days after
last vaccination |
Geometric mean titres for all the four viral strains in the two groups, 28 days
after last vaccination |
28 days after
last vaccination |
|
|
Target Sample Size
|
Total Sample Size="304"
Sample Size from India="304"
Final Enrollment numbers achieved (Total)= "306"
Final Enrollment numbers achieved (India)="306" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
04/09/2017 |
| Date of Study Completion (India) |
28/02/2018 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
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 phase 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 children. Three hundred and four 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. The enrolled subjects will be divided into three cohorts: Cohort 1 (9 to 17 years), Cohort 2 (3 to 8 years) and Cohort 3 (6 to 35 months). Subjects in Cohort 1 (9 to 17 years) will receive a single dose of Inactivated Influenza vaccine at the baseline visitas per their allocated study group and will be followed up on visit 2 (day 14), visit 3 (day 28, immunogenicity assessment) and visit 4 (day 42, end of study). Subjects in Cohort 2 (3 to 8 years) and Cohort 3 (6 to 35 months) will receive two doses of Inactivated Influenza vaccine at baseline visit and visit 3 (28 days after first vaccination) as per their allocated study group and will be followed on visit 2 (day 14), visit 4 (14 days after second vaccination), visit 5 (28 days after second vaccination, immunological assessment) and visit 6 (42 days after second vaccination). A pre vaccination and a post vaccination (day 28 after last dose) 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 criteria set by the USFDA for licensure of seasonal inactivated Influenza vaccines in pediatric population. 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, 28 days after last vaccination. The safety of the vaccine will be assessed by recording the adverse events occurring during the entire course of the study |