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

Last updated: March 27, 2025
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

4

Condition

N/A

Treatment

Fluarix Tetra Vaccine

Clinical Study ID

NCT05648357
218702
  • Ages > 65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female participants aged >= 65 years of age

  • Participants and/or legally acceptable representative (s) (LAR) who in the opinionof 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 participantand/or participant's LAR(s) after the study has been explained according to thelocal authority requirements and prior to performance of any study-specificprocedure

Exclusion

Exclusion Criteria:

  • History of severe allergic reactions (e.g., anaphylaxis) to any component of thevaccine, including egg protein, or following a previous dose of any influenzavaccine.

  • Receipt of licensed vaccine, immune sera and/or any blood products, or aninvestigational trial agent within previous 30 days or planned during theirparticipation in the trial.

  • Receipt of any flu vaccine within 6 months before trial start or any other vaccinewithin 30 days before the trial.

  • Receipt of any dose of a Coronavirus Disease 2019 (COVID-19) vaccine within 15 daysof trial start.

  • History of Guillain-Barré Syndrome.

  • Altered immune status or chronic administration (defined as more than 14 days) ofimmunosuppressants or other immune-modifying agents within six months prior toadministration of trial vaccine.

  • History of acute infectious disease or acute respiratory illness needing antibioticsor antivirals in the previous 7 days, based on investigator's judgement.

  • If a participant candidate has fever, the trial vaccination should be postponed towhen 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 oralroute.

  • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renalfunctional abnormality, as determined by medical history, physical examination, orlaboratory screening tests.

  • Any other clinical condition that, in the opinion of the investigator, might poseadditional risk to the participant due to participation in the trial.

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Fluarix Tetra Vaccine
Phase: 4
Study Start date:
December 14, 2023
Estimated Completion Date:
February 26, 2024

Connect with a study center

  • GSK Investigational Site

    Vishakhapatnam, Andhra Pradesh 530002
    India

    Site Not Available

  • GSK Investigational Site

    Belagavi, 590010
    India

    Site Not Available

  • GSK Investigational Site

    Kattankulathur, 603211
    India

    Site Not Available

  • GSK Investigational Site

    Nashik, 422003
    India

    Site Not Available

  • GSK Investigational Site

    Varanasi, 221010
    India

    Site Not Available

  • GSK Investigational Site

    Vishakha Patnam, 530002
    India

    Site Not Available

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