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A Study to Assess the Safety and Immune Response of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India

Primary Purpose

Influenza, Human

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fluarix Tetra Vaccine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza, Human

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 Coronavirus Disease 2019 (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 six 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 judgement. 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 degree Celsius (°C) (100.4 degrees Fahrenheit [°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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Participants receiving Fluarix tetra vaccine

    Arm Description

    Participants aged 65 years and above receive 1 dose of Fluarix tetra vaccine.

    Outcomes

    Primary Outcome Measures

    Percentage of participants reporting each solicited administration site event
    The solicited administration site events are pain, redness, and swelling.
    Percentage of participants reporting each solicited systemic events
    The solicited systemic events are fever, headache, myalgia (muscle pain), arthralgia (joint pain), fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), sweating, and shivering.
    Percentage of participants reporting unsolicited adverse events (AEs)
    An unsolicited AE is an event reported in addition to the solicited AEs during the clinical study. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
    Percentage of participants reporting serious adverse events (SAEs)
    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant.

    Secondary Outcome Measures

    Geometric mean titers (GMT) of serum hemagglutination-inhibiting (HI) antibodies
    Serum HI antibodies against the four-influenza vaccine (or vaccine-like) strains are expressed as GMTs.
    Mean geometric increase (MGI) of serum HI antibodies
    MGI is defined as the fold increase in post-vaccination serum HI GMTs.
    Percentage of participants with Seroconversion rate (SCR)
    SCR is defined as the percentage of participants who have either a pre-vaccination titer less than (<) 1:10 and a postvaccination titer greater than or equal to (>=) 1:40 or a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.
    Percentage of participants with Seroprotection rate (SPR)
    SPR is defined as the percentage of participants with a serum HI titer >=1:40.

    Full Information

    First Posted
    December 5, 2022
    Last Updated
    July 12, 2023
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05648357
    Brief Title
    A Study to Assess the Safety and Immune Response of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    April 22, 2024 (Anticipated)
    Study Completion Date
    April 22, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to gather additional evidence of the safety and immunogenicity of 1 dose of Fluarix Tetra (0.5 milliliter [mL]) (Northern Hemisphere (NH)2023-2024) in individuals aged 65 years and above to fulfill a post-approval condition imposed by the Indian regulatory authorities (CDSCO) for this age group in India.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Influenza, Human

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    250 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Participants receiving Fluarix tetra vaccine
    Arm Type
    Experimental
    Arm Description
    Participants aged 65 years and above receive 1 dose of Fluarix tetra vaccine.
    Intervention Type
    Biological
    Intervention Name(s)
    Fluarix Tetra Vaccine
    Intervention Description
    A single dose of Fluarix Tetra vaccine administered intramuscularly (IM) on day 1.
    Primary Outcome Measure Information:
    Title
    Percentage of participants reporting each solicited administration site event
    Description
    The solicited administration site events are pain, redness, and swelling.
    Time Frame
    From Day 1 to Day 7
    Title
    Percentage of participants reporting each solicited systemic events
    Description
    The solicited systemic events are fever, headache, myalgia (muscle pain), arthralgia (joint pain), fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), sweating, and shivering.
    Time Frame
    From Day 1 to Day 7
    Title
    Percentage of participants reporting unsolicited adverse events (AEs)
    Description
    An unsolicited AE is an event reported in addition to the solicited AEs during the clinical study. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
    Time Frame
    From Day 1 to Day 21
    Title
    Percentage of participants reporting serious adverse events (SAEs)
    Description
    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant.
    Time Frame
    From Day 1 to Day 21
    Secondary Outcome Measure Information:
    Title
    Geometric mean titers (GMT) of serum hemagglutination-inhibiting (HI) antibodies
    Description
    Serum HI antibodies against the four-influenza vaccine (or vaccine-like) strains are expressed as GMTs.
    Time Frame
    At Baseline (Day 1) and Day 22
    Title
    Mean geometric increase (MGI) of serum HI antibodies
    Description
    MGI is defined as the fold increase in post-vaccination serum HI GMTs.
    Time Frame
    At Day 22
    Title
    Percentage of participants with Seroconversion rate (SCR)
    Description
    SCR is defined as the percentage of participants who have either a pre-vaccination titer less than (<) 1:10 and a postvaccination titer greater than or equal to (>=) 1:40 or a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.
    Time Frame
    At Day 22
    Title
    Percentage of participants with Seroprotection rate (SPR)
    Description
    SPR is defined as the percentage of participants with a serum HI titer >=1:40.
    Time Frame
    At Day 1 and Day 22

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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 Coronavirus Disease 2019 (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 six 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 judgement. 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 degree Celsius (°C) (100.4 degrees Fahrenheit [°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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    US GSK Clinical Trials Call Center
    Phone
    877-379-3718
    Email
    GSKClinicalSupportHD@gsk.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    EU GSK Clinical Trials Call Center
    Phone
    +44 (0) 20 89904466
    Email
    GSKClinicalSupportHD@gsk.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    IPD for this study will be made available via the Clinical Study Data Request site.
    IPD Sharing Time Frame
    IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
    IPD Sharing Access Criteria
    Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

    Learn more about this trial

    A Study to Assess the Safety and Immune Response of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India

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