| CTRI Number |
CTRI/2018/02/012222 [Registered on: 28/02/2018] Trial Registered Prospectively |
| Last Modified On: |
26/11/2018 |
| 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
Immunogenicity and Safety of Influvac® in adults. |
|
Scientific Title of Study
|
A Randomized, Two-arm, Observer-blind, Parallel-group, Activecontrolled,
Multi-center Clinical Study to Evaluate the
Immunogenicity and Safety of Influvac® Tetra compared to
VaxiFlu-4 in Healthy Adult and Elderly Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No.: INFQ3005, Version no. 1, dated 01.09.2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manish Agarwal |
| Designation |
Director and Consultant Diabetologist |
| Affiliation |
Medilink Hospital |
| Address |
Medilink Hospital and Research Center
Basement Medilink Hospital Near Shyamal Cross Road
132 ft ring road
Satelite Ahmedabad-380015 Gujarat India
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825443397 |
| Fax |
|
| Email |
medilinkresearchcentre@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhangi Desai |
| Designation |
Associate Director Clinical Operations and Pharmacovigilance |
| Affiliation |
Abbott India Limited |
| Address |
Floor 16 Godrej BKC Plot No C 68 BKC Near MCA Club
Bandra East Mumbai 400 051 India
Mumbai (Suburban)
MAHARASHTRA
400051
India |
| Phone |
|
| Fax |
|
| Email |
shubhangi.desai@abbott.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhangi Desai |
| Designation |
Associate Director Clinical Operations and Pharmacovigilance |
| Affiliation |
Abbott India Limited |
| Address |
Floor 16 Godrej BKC Plot No C 68 BKC Near MCA Club
Bandra East Mumbai 400 051 India
Mumbai (Suburban)
MAHARASHTRA
400051
India |
| Phone |
|
| Fax |
|
| Email |
shubhangi.desai@abbott.com |
|
|
Source of Monetary or Material Support
|
|
Abbott India Limited
Floor 16, Godrej BKC
Plot No.C-68, BKC
Near MCA Club, Bandra (E)
Mumbai-400051, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Abbott India Limited |
| Address |
Floor 16, Godrej BKC,
Plot No. C – 68, BKC,
Near MCA Club, Bandra (E)
Mumbai – 400 051 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 20 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijay Shukla |
Ajanta Research Centre |
Ajanta hospital and IVF Centre, 765, ABC Complex, Kanpur Road, Alambagh
Lucknow- 226005
Uttar Pradesh
Lucknow
UTTAR PRADESH |
9839093246
dr.vijayshukla@yahoo.com |
| Dr Arpit Jain |
Artemis Hospitals |
Artemis Hospitals
Sector 51,
Gurgoan- 122001, Haryana
Gurgaon
HARYANA |
91-9618412333
drvikramvr@gmail.com |
| Dr D Anil Kumar |
Gandhi Hospital |
Gandhi Hospital, Musheerabad, Secunderabad-500003
Hyderabad
ANDHRA PRADESH |
9440523903
anilddrmd@gmail.com |
| Dr Anupam Mandal |
IPGMER and SSKM Hospital |
244 A.J.C. Bose Road, Kolkata, West Bengal 70002
Kolkata
WEST BENGAL |
9434120356
mandalanupam75@gmail.com |
| Dr Vikram Vardhan Remella |
King George Hospital |
Vishakhapatnam-530002, Andhra Pradesh
Visakhapatnam
ANDHRA PRADESH |
91-9618412333
drvikramvr@gmail.com |
| Dr Falguni Parikh |
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute |
2nd Floor, Medical Research Department
Four Bungalows, Andheri [W] Mumbai 400053,Maharashtra, India.
Mumbai
MAHARASHTRA |
9320206640
falguni.parikh@relianceada.com |
| Dr Ranjith V |
Krishna Rajendra Hospital |
Irwin Road, Mysuru, Karnataka 570001
Mysore
KARNATAKA |
91-9448188588
ranjithvmmcri@gmail.com |
| Dr Sunil Prem Chand Masand |
Maharaja Agrasen Hospita |
Punjabi Bagh New Delhi
New Delhi
DELHI |
9811349711
sunilmassand@yahoo.com |
| Dr Manish Agarwal |
Medilink Hospital & Research Center |
Basement Medilink Hospital,Near Shyamal Cross Road,
132,ft,ring road,Satelite,Ahmedabad-380015,Gujarat ,India.
Ahmadabad
GUJARAT |
9825443397
medilinkresearchcentre@yahoo.com |
| Dr Arun Narayan |
MS Ramaiah Memorial Hospital |
MSRIT Post, Bangalore 560954
Bangalore
KARNATAKA |
9341255517
contact@msrmh.com |
| Dr Manoj Kumar Srivastava |
OM Research Centre |
Om Surgical Center & Maternity Home, Shri Krishna Nagar Colony, Ashapur, Varanasi, Uttar Pradesh 221007
Varanasi
UTTAR PRADESH |
91-9415256272
omresearchcentre@gmail.com |
| Dr Viral Shah |
Panchshil Hospital |
Nr. Sabarmati Police Station, High-Way, Ramnagar,
Sabarmati,
Ahmedabad-380005,
India
Ahmadabad
GUJARAT |
9099047007
panchshilhospital@yahoo.com |
| Dr Sujaya Menon |
PGS institute of Medical Sciences & Research |
Post Box No. 1674, Peelamedu, Coimbatore - 641004
Coimbatore
TAMIL NADU |
91-422-2570170
drsujaya_menon@yahoo.co.in |
| Dr Indraneel Basu |
Popular Hospital |
N-10/60, A-2, D.L.W. Road, Near Flyover, Kakarmatta, Varanasi, Uttar Pradesh 221004
Varanasi
UTTAR PRADESH |
9935036063
dribasumd@yahoo.co.in |
| Dr Sunil Naik |
Rajiv Gandhi Institute of Medical Sciences |
Srikakulam & RIMS Government General Hospital Situated at Srikakulam-532001, Andhra Pradesh, India
Srikakulam
ANDHRA PRADESH |
9440828299
rimsresearch@gmail.com |
| Dr Peersab Pinjar |
S.S institute of medical Sciences and Research center |
NH 4, Bypass Road
Davangere- 577005, Karnataka
Davanagere
KARNATAKA |
9886725133
drpeersab@gmail.com |
| Dr Shishir Joshi |
Sahyadri Hospital |
Plot No. 13 S, Swami Vivekanand Road, Survey No. 573, City No 281, Bibvewadi, Pune, Maharashtra 411037
Pune
MAHARASHTRA |
9822315340
drshishirj@yahoo.com |
| Dr K V Giriraja |
Saptageri Institue of Medical Science and Research Centre |
No 15 Chikkasandra Hessaraghatta Main Road
Bangalore- 560090, Karnataka
Bangalore
KARNATAKA |
9448039952
gkanakapura@yahoo.com |
| Dr Pravin Dinkar Supe |
Supe Heart and Diabetes Hospital and Research Center |
Opp. Adharashram, Gharpure Ghat, Near Rungtha School, Ashok Sthambh,
Nasik- 422002, Maharashtra
Nashik
MAHARASHTRA |
91-9405366165
pravinsupe@gmail.com |
| Dr Pradeep Kumar Mishra |
Yashoda Hospital |
Yashoda Hospital Behind Harihara, Kala Bhawan, Secunderabad-500007, Andhra Pradesh
Hyderabad
ANDHRA PRADESH |
9849246909
pkmishra_doc@reddiffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 20 |
| Name of Committee |
Approval Status |
| EC, Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
Not Applicable |
| EC, Medilink Hospital and Research Center |
Approved |
| Ethics Committee Ajanta Hospital and IVF Centre |
Approved |
| Ethics committee, Sapthagiri Institute of Medical and Research Centre |
Approved |
| Ethics Committee, Supe hospital |
Approved |
| IEC Krishna Rajendra Hospital |
Approved |
| IEC Om Surgical Center |
Approved |
| IEC, Artemis Health Science |
Approved |
| IECKGH |
Approved |
| Institutional Ethics Committee Gandhi Medical College |
Approved |
| Institutional Ethics Committee, PSG institute of Medical Sciences and Research |
Not Applicable |
| Institutional Ethics Committee, Rajiv Gandhi Institute of Medical Sciences |
Approved |
| Institutional Ethics Review Board, SSIMSRC |
Approved |
| IPGMER |
Approved |
| Maharaja Agrasen Hospital EC |
Not Applicable |
| MS Ramaiah Memorial Hospital EC |
Not Applicable |
| Panchshil Hospital EC |
Approved |
| Popular Hospital Ethics Committee |
Approved |
| Sahyadri Hospital EC |
Approved |
| Yashoda Hospital EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
It is a influenza vaccine study we are looking at healthy or stable condition patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Influvac® Tetra (influenza
vaccine, surface antigen,
inactivated) |
15 mcg HA per viral strain:
- an A (H1N1)
- an A (H3N2)
- a B/Yamagata lineage
- a B/Victoria lineage |
| Comparator Agent |
VaxiFlu-4 |
15 mcg HA per viral strain: - an A (H1N1) - an A (H3N2) - a B/Yamagata lineage - a B/Victoria lineage |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female subjects more than or equal to 18 years of age at the time of enrolment who the investigator
believes that they can and will comply with the requirements of the protocol (e.g. completion
of the subject diaries, return for follow-up visits and be available for telephone contacts).
2. Subjects in stable health determined from medical history, physical examination and clinical
judgment of the Investigator. Subjects may have underlying illnesses as long as their
symptoms/signs are controlled. If at the time of enrolment the subject has been on regular
prescribed medication for at least 3 months for a preexisting condition, the dose must have
been stable for at least 3 months preceding study vaccination.
3. The subjects sign and date a written, informed consent form (ICF).
4. Females of childbearing potential may be enrolled in the study, if the subject:
a. has practiced highly effective contraception for 30 days prior to vaccination, and
b. has a negative urine pregnancy test on the day of vaccination, and
c. has agreed to continue highly effective contraception during the entire study period. |
|
| ExclusionCriteria |
| Details |
1. History of adverse reaction or hypersensitivity to influenza vaccines or its components,
incl. egg, or chicken proteins.
2. History of Guillain-Barré syndrome, other progressive neurological diseases or seizures
(subject who had a single uncomplicated febrile convulsion in the past could be
included).
3. Any confirmed, acute or historic (within 6 months prior to enrollment), or suspected
immunosuppressive or immunodeficient condition based on medical history and physical
examination (no laboratory testing required).
4. Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational)
or laboratory-confirmed influenza infection in the 6 months preceding the study
vaccination.
5. Receipt of any vaccine within the preceding 30 days or planned vaccination during the
study within 30 days after any study vaccine administration.
6. Having fever and/or acute disease or infection on the day of study vaccination (enrolment
can be deferred for up to 2 weeks provided subject remains otherwise eligible). Fever is
defined as a body temperature more than or equal to 38.0 oC (measured by oral method). Subjects with a
minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may
be enrolled at the discretion of the investigator.
7. Chronic systemic administration (defined as more than 14 days) of immunosuppressant
or immune-modifying medication (such as corticosteroids and monoclonal antibodies)
during 3 months prior to the study vaccination or planned use thereof during the study.Topical use of corticosteroids (e.g., cream, ocular drops, inhalation and intranasal
sprays), within the dosage noted on the product label, is allowed.
8. Receipt of immunoglobulins or any blood products within the 3 months preceding the
study vaccination and planned administration during the study period.
9. Use of cytotoxic drugs, anticancer chemotherapy or radiation therapy within 36 months
before the day of study vaccination.
10. Being a solid organ or bone marrow/stem cell transplant recipient.
11. Participation in a placebo-controlled influenza vaccine clinical trial any time prior to
entering this study if the treatment arm is not known.
12. Any condition that in the opinion of the Investigator would pose a health risk to the
subject if enrolled or could interfere with the evaluation of the vaccine including (but not
limited to) bleeding disorder, acute or progressive clinically-significant pulmonary,
cardiovascular, hepatic or renal functional abnormality, as determined by medical history
and/or physical examination. Receipt of another investigational agent within 30 days
prior to study vaccination, or planned exposure to an investigational or noninvestigational
product (pharmaceutical product or device) during the entire study period.
14. Pregnant or lactating female.
15. Known drug or alcohol abuse.
16. Planned surgery requiring a general anesthetic, or planned surgery requiring inpatient
hospitalization for at least 24 hours during the entire study period.
17. Being an employee (or family member of the employee) of the Sponsor/ Contract
Research Organization conducting this study or (family members of) personnel of the
study site involved in this study.
18. Any applicable contraindication as per the Prescribing information of VaxiFlu-4 by
Zydus Cadilla. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy:
To describe and compare the immunogenicity of each vaccination group per age group (adults aged 18-60 years and elderly adults aged more than or equal to 61 years)
Safety:
To describe the safety (unsolicited AEs) and tolerability (reactogenicity) of each vaccination group in each age group (adults aged 18-60 years and elderly adults aged more than or equal to 61 years) |
End of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety objective - To describe the safety (unsolicited AEs) and tolerability (reactogenicity) of each vaccination group in each age group (adults aged 18-60 years and elderly adults aged ≥ 61 years) |
end of the study |
|
|
Target Sample Size
|
Total Sample Size="480"
Sample Size from India="480"
Final Enrollment numbers achieved (Total)= "480"
Final Enrollment numbers achieved (India)="480" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2018 |
| Date of Study Completion (India) |
30/04/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
A randomized, two-arm, observer-blind, parallel-group, active-controlled, multi-center clinical study to evaluate the immunogenicity and safety of Influvac® Tetra compared to VaxiFlu-4 in healthy adult and elderly subjects for 480 subjects in 4 groups in the age group above 18 years. |