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

NCT05648357 | Completed Phase 4 Results

• 1 other identifier: 218702
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 6

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.

Conditions

Influenza, Human

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies

  At Baseline (Day 1) and Day 22

• Mean Geometric Increase (MGI) of Serum HI Antibodies

  At Day 22 (compared with Baseline [Day 1])

• Number of Participants With Seroconversion Rate (SCR)

  At Day 22

• Number of Participants With Seroprotection Rate (SPR)

  At Day 1 and Day 22

Study Arms (1)

Quadrivalent seasonal influenza (FLU D-QIV) vaccine group

EXPERIMENTAL

Participants received 1 dose of seasonal FLU vaccine at Day 1.

Biological: Fluarix Tetra Vaccine

Interventions

Fluarix Tetra Vaccine BIOLOGICAL

A single dose of Fluarix Tetra vaccine administered intramuscularly (IM) on day 1.

Quadrivalent seasonal influenza (FLU D-QIV) vaccine group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Belagavi, 590010, India

Location

GSK Investigational Site

Kattankulathur, 603211, India

Location

GSK Investigational Site

Nashik, 422002, India

Location

GSK Investigational Site

Nashik, 422003, India

Location

GSK Investigational Site

Varanasi, 221010, India

Location

GSK Investigational Site

Visakhapatnam, 530002, India

Location

Related Publications (1)

• Jain V, Cauwberghs F, Qian H, Best-Sule K, Gupta V, Tatchou EN, Struyf F. Reactogenicity, safety, and immunogenicity of a quadrivalent seasonal influenza vaccine in adults aged 65 years and older: Phase 4 study results from India during December 2023-February 2024. Hum Vaccin Immunother. 2025 Dec;21(1):2578084. doi: 10.1080/21645515.2025.2578084. Epub 2025 Oct 29.

  PMID: 41159757 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 13, 2022
• Study Start: December 14, 2023
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: March 28, 2025
• Results First Posted: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

IN (6)