Clinical trial NCT05648357: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza, Human
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2022-12-13
Enrollment: 250
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Reporting Any Solicited Administration Site Adverse Event
timeFrame: Day 1 to Day 7
measure: Number of Participants Reporting Any Solicited Systemic Events
timeFrame: Day 1 to Day 7
measure: Number of Participants Reporting Unsolicited Adverse Events (AEs)
timeFrame: Day 1 to Day 21
measure: Number of Participants Reporting Serious Adverse Events (SAEs)
timeFrame: Day 1 to Day 21
Secondary outcomes:
measure: Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies
timeFrame: At Baseline (Day 1) and Day 22
measure: Mean Geometric Increase (MGI) of Serum HI Antibodies
timeFrame: At Day 22 (compared with Baseline [Day 1])
measure: Number of Participants With Seroconversion Rate (SCR)
timeFrame: At Day 22
measure: Number of Participants With Seroprotection Rate (SPR)
timeFrame: At Day 1 and Day 22
Other outcomes:
Locations:
city: Belagavi
country: India
facility: GSK Investigational Site
city: Kattankulathur
country: India
facility: GSK Investigational Site
city: Nashik
country: India
facility: GSK Investigational Site
city: Nashik
country: India
facility: GSK Investigational Site
city: Varanasi
country: India
facility: GSK Investigational Site
city: Vishakha Patnam
country: India
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: