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

January 29, 2024 updated by: GlaxoSmithKline

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
      • Belagavi, India, 590010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Madhav Prabhu
    • Andhra Pradesh
      • Vishakhapatnam, Andhra Pradesh, India, 530002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gnana Raju
    • Maharashtra
      • Nashik, Maharashtra, India, 422002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pravin Supe
      • Nashik, Maharashtra, India, 422003
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kailash Rathi
    • Tamil Nadu
      • Kattankulathur, Tamil Nadu, India, 603211
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Satyajit Mohapatra
    • Uttar Pradesh
      • Varanasi, Uttar Pradesh, India, 221010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ritandhar Misra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants receiving Fluarix tetra vaccine
Participants aged 65 years and above receive 1 dose of Fluarix tetra vaccine.
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
Percentage of participants reporting each solicited administration site event
Time Frame: From Day 1 to Day 7
The solicited administration site events are pain, redness, and swelling.
From Day 1 to Day 7
Percentage of participants reporting each solicited systemic events
Time Frame: From Day 1 to Day 7
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.
From Day 1 to Day 7
Percentage of participants reporting unsolicited adverse events (AEs)
Time Frame: From Day 1 to Day 21
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.
From Day 1 to Day 21
Percentage of participants reporting serious adverse events (SAEs)
Time Frame: From Day 1 to Day 21
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.
From Day 1 to Day 21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric mean titers (GMT) of serum hemagglutination-inhibiting (HI) antibodies
Time Frame: At Baseline (Day 1) and Day 22
Serum HI antibodies against the four-influenza vaccine (or vaccine-like) strains are expressed as GMTs.
At Baseline (Day 1) and Day 22
Mean geometric increase (MGI) of serum HI antibodies
Time Frame: At Day 22
MGI is defined as the fold increase in post-vaccination serum HI GMTs.
At Day 22
Percentage of participants with Seroconversion rate (SCR)
Time Frame: At Day 22
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
Percentage of participants with Seroprotection rate (SPR)
Time Frame: At Day 1 and Day 22
SPR is defined as the percentage of participants with a serum HI titer >=1:40.
At Day 1 and Day 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2023

Primary Completion (Estimated)

April 4, 2024

Study Completion (Estimated)

April 4, 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)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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