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Influenza, HumanPhase 4NCT05648357

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 Phase 4 study testing Fluarix Tetra Vaccine in people with Influenza, Human, run by GlaxoSmithKline at 6 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza, Human
What is being tested?
Fluarix Tetra Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
6 sitesIndia
Study dates
14 Dec 2023to 26 Feb 2024
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

India6 sites

  • GSK Investigational Site

    Belagavi, 590010

  • GSK Investigational Site

    Kattankulathur, 603211

  • GSK Investigational Site

    Nashik, 422002

  • GSK Investigational Site

    Nashik, 422003

  • GSK Investigational Site

    Varanasi, 221010

  • GSK Investigational Site

    Visakhapatnam, 530002

Other trials in India

About this study

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

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.

Being tested
Fluarix Tetra Vaccine
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluarix Tetra VaccineBiological

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

Study groups in NCT05648357
Study groupRoleWhat they receive
Quadrivalent seasonal influenza (FLU D-QIV) vaccine groupExperimentalParticipants received 1 dose of seasonal FLU vaccine at Day 1.
Receives: Biological: Fluarix Tetra Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Reporting Any Solicited Administration Site Adverse Event

    The solicited administration site adverse events included pain, redness and swelling.

    Measured: Day 1 to Day 7

  2. 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.

    Measured: Day 1 to Day 7

  3. 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.

    Measured: Day 1 to Day 21

  4. 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.

    Measured: Day 1 to Day 21

Secondary outcomes (4)

  1. 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.

    Measured: At Baseline (Day 1) and Day 22

  2. 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.

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

  3. 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.

    Measured: At Day 22

  4. Number of Participants With Seroprotection Rate (SPR)

    SPR is defined as the percentage of participants with a serum HI titer >=1:40.

    Measured: At Day 1 and Day 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2022
  2. Study start14 Dec 2023
  3. Primary completion26 Feb 2024
  4. Study completion26 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05648357
Sponsor's protocol ID
218702
Status last verified
Mar 2025
First submitted
5 Dec 2022
Last updated
28 Mar 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • 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.

    PubMed 41159757

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluarix Tetra Vaccine in people with Influenza, Human, run by GlaxoSmithKline at 6 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting Any Solicited Administration Site Adverse Event (time frame: Day 1 to Day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05648357, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.

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