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

Influenza, Human Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05648357
• Other study ID #: 218702
• Status: Completed
• Phase: Phase 4
• Start date: December 14, 2023
• Est. completion date: February 26, 2024

Study information

• Verified date: May 2024
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 group in India.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 26, 2024
• Est. primary completion date: February 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza, Human

Intervention

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

Locations

Country	Name	City	State
India	GSK Investigational Site	Belagavi	Karnataka
India	GSK Investigational Site	Kattankulathur	Tamil Nadu
India	GSK Investigational Site	Nashik	Maharashtra
India	GSK Investigational Site	Nashik	Maharashtra
India	GSK Investigational Site	Varanasi	Uttar Pradesh
India	GSK Investigational Site	Vishakhapatnam	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants reporting each solicited administration site event	The solicited administration site events are pain, redness, and swelling.	From Day 1 to Day 7
Primary	Percentage of participants reporting each solicited systemic events	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
Primary	Percentage of participants reporting unsolicited adverse events (AEs)	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
Primary	Percentage of participants reporting serious adverse events (SAEs)	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	Geometric mean titers (GMT) of serum hemagglutination-inhibiting (HI) antibodies	Serum HI antibodies against the four-influenza vaccine (or vaccine-like) strains are expressed as GMTs.	At Baseline (Day 1) and Day 22
Secondary	Mean geometric increase (MGI) of serum HI antibodies	MGI is defined as the fold increase in post-vaccination serum HI GMTs.	At Day 22
Secondary	Percentage 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
Secondary	Percentage 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