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

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Biological: Fluarix Tetra Vaccine

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Belagavi, India, 590010
    • GSK Investigational Site
  • Kattankulathur, India, 603211
    • GSK Investigational Site
  • Nashik, India, 422002
    • GSK Investigational Site
  • Nashik, India, 422003
    • GSK Investigational Site
  • Varanasi, India, 221010
    • GSK Investigational Site
  • Vishakha Patnam, India, 530002
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quadrivalent seasonal influenza (FLU D-QIV) vaccine group; Participants received 1 dose of seasonal FLU vaccine at Day 1.	Biological: Fluarix Tetra Vaccine; A single dose of Fluarix Tetra vaccine administered intramuscularly (IM) on day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Any Solicited Administration Site Adverse Event	The solicited administration site adverse events included pain, redness and swelling.	Day 1 to Day 7
Number of Participants Reporting Any Solicited Systemic Events	The solicited systemic events included fever, headache, myalgia (muscle pain), arthralgia (joint pain), fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), sweating and shivering.	Day 1 to Day 7
Number of Participants Reporting Unsolicited Adverse Events (AEs)	An unsolicited AE is defined as 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.	Day 1 to Day 21
Number of Participants Reporting Serious Adverse Events (SAEs)	A SAE is defined as 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.	Day 1 to Day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies	Serum HI antibodies against the four-influenza vaccine strains are expressed as GMTs, in titers. The assessed strains are: A/Victoria/4897/2022 (H1N1), A/Darwin/9/2021 (H3N2), B/Austria/1359417/2021 and B/Phuket/3073/2013.	At Baseline (Day 1) and Day 22
Mean Geometric Increase (MGI) of Serum HI Antibodies	MGI is defined as the fold increase in post-vaccination serum HI GMTs compared with Baseline. Analysis was performed for four influenza strains: A/Victoria/4897/2022 (H1N1), A/Darwin/9/2021 (H3N2), B/Austria/1359417/2021 and B/Phuket/3073/2013.	At Day 22 (compared with Baseline [Day 1])
Number 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.	At Day 22
Number of Participants With Seroprotection Rate (SPR)	SPR is defined as the percentage of participants with a serum HI titer >=1:40.	At Day 1 and Day 22

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2023
• Primary Completion (Actual): February 26, 2024
• Study Completion (Actual): February 26, 2024

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human
• Other Study ID Numbers: 218702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• 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