| CTRI Number |
CTRI/2022/12/048070 [Registered on: 13/12/2022] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study to check effect and safety of Influenza Vaccine in elder patients (aged 65 years and more) |
|
Scientific Title of Study
|
A single-arm, open-label, multi-center, phase IV trial to evaluate the reactogenicity, safety, and immunogenicity of quadrivalent seasonal influenza vaccine (Fluarix Tetra) in participants aged 65 years and older in India |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| 218702 Version 2.0, 05 May 2023, Amendment 01 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
|
| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Jinu Jose |
| Designation |
VP, RDS Sales and Clinical Operations, India |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
Omega Embassy Tech Square Marathahalli Sarjapura Outer Ring Road Kadubeesanahalli
Bangalore
KARNATAKA
560103
India |
| Phone |
9886203019 |
| Fax |
|
| Email |
jinu.jose@iqvia.com |
|
Details of Contact Person
Public Query
|
| Name |
Jinu Jose |
| Designation |
VP, RDS Sales and Clinical Operations, India |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
Omega Embassy Tech Square Marathahalli Sarjapura Outer Ring Road Kadubeesanahalli
Bangalore
KARNATAKA
560103
India |
| Phone |
9886203019 |
| Fax |
|
| Email |
jinu.jose@iqvia.com |
|
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Source of Monetary or Material Support
|
| GlaxoSmithKline Biologicals SA, Rixensart, Belgium |
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Primary Sponsor
|
| Name |
GlaxoSmithKline Biologicals SA |
| Address |
Rue de lInstitut 89, 1330 Rixensart, Belgium |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| IQVIA RDS INDIA PRIVATE LIMITED |
Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli, Bengaluru, Karnataka – 560103
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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 Santanu Munsi |
Calcutta School of Tropical Medicine |
Department of Clinical & Experimental Pharmacology
108 Chittaranjan Avenue Government of West Bengal Kolkata 700073 West Bengal India
Kolkata
WEST BENGAL |
9830060666
22123698
drsm03@gmail.com |
| Dr Ritandhar Misra |
Galaxy Hospital |
Galaxy Hospital A Venture of Galaxy Life Care Services Pvt Ltd Clinical Trial Room 4th Floor
Plot No 5 6 & 7 Dayal Enclave Mahmoorganj Varanasi 221010 Uttar Pradesh India
Varanasi
UTTAR PRADESH |
9415565484
dr.ritandharmisra@gmail.com |
| Dr Konatham Rambabu |
King George Hospital |
King George Hospital Clinical Research Room 1st Floor Rajendra Prasad Ward Maharanipeta Visakhapatnam 530002 Andhra Pradesh India
Visakhapatnam
ANDHRA PRADESH |
9177747328
drkrambaburesearch@gmail.com |
| Dr Madhav Prabhu |
KLES Prabhakar Kore Hospital and Medical Research Centre |
KLES Prabhakar Kore Hospital and Medical Research Centre Site management office G 2 floor Nehru Nagar Belagavi 590010 Karnataka India
Belgaum
KARNATAKA |
9738462380
wiseman2380@yahoo.com |
| Dr Satyajit Mohapatra |
SRM Medical College Hospital and Research Centre |
SRM Medical College Hospital and Research Centre SRM Centre for Clinical Trials and Research 3rd Floor E Block SRM Nagar Potheri Kattankulathur 603203 Chengalpattu District Tamil Nadu India
Chennai
TAMIL NADU |
9791161626
satyajitmp@gmail.com |
| Dr Pravin Dinkar Supe |
Supe Heart & Diabetes Hospital and Research Centre |
Supe Heart & Diabetes Hospital and Research Centre Research Room no 3 1st Floor Opp Adhar Asharam Near Rungta School Gharure Ghat Ashok Stambh Nashik 422002 Maharashtra India
Nashik
MAHARASHTRA |
9405366165
pravinsupe@ymail.com |
| Dr Kailash Jagdish Rathi |
Suyog Hospital |
Suyog Hospital Clinical Research Department 2nd floor B Wing Krushi Utapanna Bazar Samiti Sankul Dindori Road Panchavati Nashik 422003 Maharashtra India
Nashik
MAHARASHTRA |
9422254748
drkrathi@gmail.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee School Of Tropical Medicine |
Submittted/Under Review |
| Ethics Committee Galaxy Hospital Galaxy Life Care Services Private Limited |
Approved |
| IEC King George Hospital |
Approved |
| Institutional Ethics Committee KLE University |
Approved |
| Institutional Ethics Committee SRM Institutes for Medical Science |
Approved |
| Supe Hospital Ethics Committee |
Approved |
| Suyog Hospital Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
Modification(s)
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J111||Influenza due to unidentified influenza virus with other respiratory manifestations, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fluarix Tetra |
Frequency: single 0.5 ml
Route of administration: intramuscular
Total duration of intervention: A single 0.5 ml intramuscular dose of Fluarix Tetra will be administered. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
Inclusion Criteria
Modification(s)
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Deviations from inclusion criteria are not allowed because they can potentially jeopardize the
scientific integrity of the trial. Therefore, adherence to the criteria as specified in the protocol is
essential.
The following criteria must be met in order to be enrolled in the trial:
• Male or female participants aged ≥65 years of age.
• Participants and/or legally acceptable representative(s) (LAR) who in the opinion of the
Investigator, can and will comply with the requirements of the protocol (e.g. completion of the
diary cards, return for follow-up visits).
• Written or witnessed/thumb printed informed consent obtained from the participant and/or
participant’s LAR(s) after the study has been explained according to the local authority
requirements and prior to performance of any study-specific procedure. |
|
| ExclusionCriteria |
| Details |
Deviations from the exclusion criteria are not allowed because they can potentially jeopardize the
scientific integrity of the trial. Therefore, adherence to the criteria as specified in the protocol is
essential.
Participants meeting ANY of the following criteria are not eligible for participation:
History of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine,
including egg protein, or following a previous dose of any influenza vaccine.
• Receipt of licensed vaccine, immune sera and/or any blood products, or an investigational trial
agent within previous 30 days or planned during their participation in the trial.
• Receipt of any flu vaccine within 6 months before trial start or any other vaccine within 30 days
before the trial.
• Receipt of any dose of a COVID-19 vaccine within 15 days of trial start.
• History of Guillain-Barré Syndrome.
• Altered immune status or chronic administration (defined as more than 14 days) of
immunosuppressants or other immune-modifying agents within 6 months prior to
administration of trial vaccine.
• History of acute infectious disease or acute respiratory illness needing antibiotics or antivirals
in the previous 7 days, based on Investigator’s judgment.
• If a participant candidate has fever, the trial vaccination should be postponed to when the fever
has resolved for at least 2 days (temporary exclusion criterion). Fever is defined as temperature
≥38.0°C (100.4°F) by any route. The preferred location for measuring temperature will be oral
route.
• Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional
abnormality, as determined by medical history, physical examination, or laboratory screening
tests.
• Any other clinical condition that, in the opinion of the Investigator, might pose additional risk
to the participant due to participation in the trial. |
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate reactogenicity and safety of Fluarix Tetra single dose 0.5 ml intramuscularly (I/M) in participants aged 65 years and above in India. |
• Number and percentage of subjects with solicited adverse events (AEs) (local as well as general) for 7 days from the date of vaccination (Day 1)
• Number and percentage of subjects with unsolicited AEs starting from the date of vaccination for 21 days.
• Number and percentage of subjects with serious adverse events (SAEs) from the date of vaccination for 21 days.
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Secondary Outcome
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| Outcome |
TimePoints |
| To evaluate immunogenicity of Fluarix Tetra single dose 0.5 ml (I/M) in participants aged 65 years and above in India |
• Geometric mean titers (GMT) of serum hemagglutination-inhibiting (HI) antibodies against the four influenza vaccine strains at baseline day 1 and 21
• Mean geometric increase at Day 21. MGI is fold increase in post-vaccination serum HI GMTs (Day 21) compared to Day 1
• Seroconversion rate at Day 21.
• Seroprotection rate at Day 1 and Day 21. SPR is defined as the percentage of subjects with a serum HI titer ≥ 1:40.
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Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "250"
Final Enrollment numbers achieved (India)="250" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/12/2022 |
| Date of Study Completion (India) |
06/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="21" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Any |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
| Overview of study design: A prospective, single-arm, open-label, multi-center, phase IV trial. Study sites: This trial will be conducted in multiple sites during northern hemisphere influenza season in India. Vaccination schedule: A single 0.5 ml intramuscular dose of Fluarix Tetra will be administered. Safety and reactogenicity monitoring: · Recording of solicited adverse events (AEs) for 7 days (Day 1 to Day 7) after vaccination · Recording of unsolicited AEs for 21 days (Day 1 to Day 21) after Fluarix Tetra is administered · Recording of SAEs for 21 days (Day 1 to Day 21) after vaccination Immunogenicity assessment: · Blood Samples: Two 5 mL blood samples will be collected, one before administration of a single dose of study vaccine at Day 1 and one at Day 21. · Laboratory testing: Serum HI antibodies will be measured against the four influenza strains that the Fluarix Tetra are designed to protect against. GMT, MGI, SCR and SPR shall be evaluated to assess immunogenicity. Type of study vaccine intervention: Open label. | |