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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
250
A single dose of Fluarix Tetra vaccine administered intramuscularly (IM) on day 1.
GSK Investigational Site
Belagavi, India
GSK Investigational Site
Kattankulathur, India
GSK Investigational Site
Nashik, India
GSK Investigational Site
Nashik, India
Number of Participants Reporting Any Solicited Administration Site Adverse Event
The solicited administration site adverse events included pain, redness and swelling.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 to Day 21
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.
Time frame: At Baseline (Day 1) and Day 22
Mean Geometric Increase (MGI) of Serum HI Antibodies
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GSK Investigational Site
Varanasi, India
GSK Investigational Site
Visakhapatnam, India
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.
Time frame: At Day 22 (compared with Baseline [Day 1])
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.
Time frame: At Day 22
Number of Participants With Seroprotection Rate (SPR)
SPR is defined as the percentage of participants with a serum HI titer \>=1:40.
Time frame: At Day 1 and Day 22