| CTRI Number |
CTRI/2022/05/042514 [Registered on: 12/05/2022] Trial Registered Prospectively |
| Last Modified On: |
28/11/2022 |
| 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 study to compare the immunogenicity and safety of Inactivated Influenza vaccine (split virion) I.P. (Tetravalent) 0.5ml in healthy children aged 6 to 35 months |
|
Scientific Title of Study
|
A prospective, randomized, two arm, parallel, active
controlled, multicentre, phase III clinical study to
compare the immunogenicity and safety of Inactivated
Influenza vaccine (split virion) I.P. (Tetravalent) 0.5ml
of M/s Cadila Healthcare Limited with Fluarix-Tetra of
M/s GlaxoSmithKline Pharmaceuticals Limited in
healthy children aged 6 to 35 months |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 21-13 (Protocol Version No. 00; Dated 7-12-2021) |
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 Limited |
| Address |
Cadila Healthcare Ltd. Zydus Corporate Park, Scheme No. 63,
Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G.
Highway
Ahmadabad
GUJARAT
382481
India |
| Phone |
|
| Fax |
|
| Email |
r.mittal@zyduslife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Cadila Healthcare Ltd. Zydus Corporate Park, Scheme No. 63,
Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G.
Highway
GUJARAT
382481
India |
| Phone |
|
| Fax |
|
| Email |
r.mittal@zyduslife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
DGM – New Product Development |
| Affiliation |
Cadila Healthcare Ltd |
| Address |
Cadila Healthcare Ltd. Zydus Corporate Park, Scheme No. 63,
Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G.
Highway
Ahmadabad
GUJARAT
382481
India |
| Phone |
|
| Fax |
|
| Email |
Jayeshsanmukhani@zyduslife.com |
|
|
Source of Monetary or Material Support
|
| Cadila Healthcare Ltd. Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj
(Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad – 382481, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Cadila Healthcare Limited |
| Address |
Cadila Healthcare Ltd. Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj
(Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad – 382481, Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kairav Kothari |
Aartham Multi Super Speciality Hospital |
Basement 2, Clinical Research room, Aartham Multi Super Speciality Hospital,
Opp. Polytechnic, NR. Panjarapole cross road,
Ambawadi, Ahmedabad - 380015
Ahmadabad
GUJARAT |
9824076534
dranjalikothari@hotmail.com |
| Dr Shreyansh Shah |
Aatman Hospital |
Basement, Research
Room, Aatman
Hospital, 5, Anveshan
Row House, Opp
Umiya Mata Mandir,
Bopal-Ghuma Road,
Bopal, Ahmedabad -
380058
Ahmadabad
GUJARAT |
9909977831
Shreyans200@yahoo.com |
| Dr Vinay Kumar Gill |
Maharaja Agrasen Superspeciality Hospital |
Basement, Maharaja
Agrasen
Superspeciality
Hospital, Central Spine,
Agrasen Aspatal Marg,
Sector No. 7,
Vidhyadhar Nagar,
Jaipur - 302039
Jaipur
RAJASTHAN |
9252101110
drvinaykgill@gmail.com |
| Dr N Ravi Kumar |
Niloufer Hospital |
Room No. 18, 1st Floor,
Department of
Pediatrics, Niloufer
Hospital (Affiliated to
Osmania Medical
College), Red Hills,
Baazar Ghat,
Lakdikapool,
Hyderabad-500004
Hyderabad
TELANGANA |
9490919293
ravik1961@yahoo.com |
| Dr Rajib Kumar Ray |
Sparsh Hospital & Critical Care Pvt Ltd |
Sparsh Hospital & Critical Care Pvt Ltd, Plot no-A/407 Saheed Nagar Bhubaneswar Khordha, Orissa - 751007 India
Khordha
ORISSA |
9338089618
drrajib2007@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sparsh Hospitals and Critical Care Private Limited, Plot no-A/407 Saheed Nagar Bhubaneswar Khordha, Orissa - 751007 India |
Approved |
| Institutional Ethics Committee, Aartham Multi Super Speciality Hospital, Opp. Polytechnic, NR. Panjarapole cross road, Ambawadi, Ahmedabad - 380015 |
Approved |
| Institutional Ethics Committee, Aatman Hospital, 5, Anveshan Row House, Opp Umiya Mata Mandir, Bopal-Ghuma Road, Bopal, Ahmedabad - 380058, Gujarat |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Superspeciality Hospital, Central Spine Agrasen Aspatal Marg, Sector No. - 7 Vidhyadhar Nagar, Jaipur, Rajasthan -302039 |
Approved |
| Institutional Ethics Committee, Osmania Medical College, Koti, Hyderabad – 500095, Telangana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy children aged 6 to 35 months |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inactivated Influenza vaccine |
Inactivated Influenza vaccine (split virion)
I.P. 0.5ml of M/s GlaxoSmithKline Pharmaceuticals
Limited (Fluarix-Tetra).
0.5ml Dose to be given at Day 0 and 28 |
| Intervention |
Inactivated Influenza vaccine |
Inactivated Influenza vaccine (split virion) I.P.
(Tetravalent) 0.5ml of M/s Cadila Healthcare Limited
0.5ml Dose to be given at Day 0 and 28 |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
35.00 Month(s) |
| Gender |
Both |
| Details |
1. Healthy subject of either gender 6 months to 35 months of age at the time of enrolment
2. Subjects should be in a good health as determined by the medical history and physical examination based on clinical judgment of the investigator
3. Informed consent from the parents of subjects.
4. Parents of subjects 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 (body 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. Participation in another clinical trial in the past 3 months
10. Have any condition that in opinion of the investigator would make the subject
unsuitable for participation in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Seroprotection rate for all the four viral strains in the two groups at the end of the study |
Day 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Seroconversion rate for all the four viral strains in the two groups at the end of study |
Day 56 |
Geometric mean titres for all the four viral strains in the two groups at the end of the
study |
Day 56 |
Safety:
1. Solicited local and systemic adverse events reported during the study
2. Unsolicited adverse events reported during the study
3. Serious adverse events reported during the study |
Day 0, Day 28 and Day 56 |
|
|
Target Sample Size
|
Total Sample Size="346"
Sample Size from India="346"
Final Enrollment numbers achieved (Total)= "346"
Final Enrollment numbers achieved (India)="346" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/05/2022 |
| Date of Study Completion (India) |
06/10/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is A prospective, randomized, two arm, parallel, active controlled, multicentre, phase III clinical study to compare the immunogenicity and safety of Inactivated Influenza vaccine (split virion) I.P. (Tetravalent) 0.5ml of M/s Cadila Healthcare Limited with Fluarix-Tetra of M/s GlaxoSmithKline Pharmaceuticals Limited. A total of 346 healthy children aged 6 to 35 months will be enrolled in this study. The primary objective of this clinical study is to compare Seroprotection rate for all the four viral strains in the two groups at the end of the study. The secondary objective is to evaluate the Immunogenicity and Safety of the vaccines. For immunogenicity - Seroconversion rate for all the four viral strains in the two groups at the end of study and Geometric mean titres for all the four viral strains in the two groups at the end of the study will be eavaluated. For Safety Safety: 1. Solicited local and systemic adverse events reported during the study, 2. Unsolicited adverse events reported during the study, 3. Serious adverse events reported during the study will be evaluated. |