Influenza, Human
Conditions
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.
Interventions
BIOLOGICALFluarix Tetra Vaccine
A single dose of Fluarix Tetra vaccine administered intramuscularly (IM) on day 1.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Serious Adverse Events (SAEs) | Day 1 to Day 21 | 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. |
| Number of Participants Reporting Any Solicited Administration Site Adverse Event | Day 1 to Day 7 | The solicited administration site adverse events included pain, redness and swelling. |
| Number of Participants Reporting Any Solicited Systemic Events | Day 1 to Day 7 | 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. |
| Number of Participants Reporting Unsolicited Adverse Events (AEs) | Day 1 to Day 21 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies | At Baseline (Day 1) and Day 22 | 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. |
| Mean Geometric Increase (MGI) of Serum HI Antibodies | At Day 22 (compared with Baseline [Day 1]) | 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. |
| Number of Participants With Seroconversion Rate (SCR) | At Day 22 | 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. |
| Number of Participants With Seroprotection Rate (SPR) | At Day 1 and Day 22 | SPR is defined as the percentage of participants with a serum HI titer \>=1:40. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group Participants received 1 dose of seasonal FLU vaccine at Day 1. | 250 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | CONSENT WITHDRAWAL, NOT DUE TO AN AE | 3 |
Baseline characteristics
| Characteristic | Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group |
|---|---|
| Age, Continuous | 71.8 YEARS STANDARD_DEVIATION 5.22 |
| Race/Ethnicity, Customized Asian - Central / South Asian Heritage | 250 Participants |
| Sex: Female, Male Female | 104 Participants |
| Sex: Female, Male Male | 146 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 250 |
| other Total, other adverse events | 70 / 250 |
| serious Total, serious adverse events | 0 / 250 |
Outcome results
Primary
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
Population: The analysis was performed on the Solicited Safety Set (SSS), which included participants that received study intervention and had solicited safety data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Number of Participants Reporting Any Solicited Administration Site Adverse Event | 44 Participants |
Primary
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
Population: SSS population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Number of Participants Reporting Any Solicited Systemic Events | 30 Participants |
Primary
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
Population: ES population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Number of Participants Reporting Serious Adverse Events (SAEs) | 0 Participants |
Primary
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
Population: Analysis was performed on Exposed Set (ES) population, which included all participants that received the study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Number of Participants Reporting Unsolicited Adverse Events (AEs) | 4 Participants |
Secondary
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
Population: Analysis was performed on the Per Protocol Set (PPS), which included all participants who received the trial intervention as per protocol, had immunogenicity results pre- and post-dose, complied with the allowed dosing/blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies | A/Victoria/4897/2022 (H1N1), Day 1 | 10.7 Titer |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies | A/Victoria/4897/2022 (H1N1), Day 22 | 187.9 Titer |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies | A/Darwin/9/2021 (H3N2), Day 1 | 20.2 Titer |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies | B/Austria/1359417/2021, Day 1 | 100.8 Titer |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies | B/Phuket/3073/2013, Day 1 | 93.3 Titer |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies | B/Phuket/3073/2013, Day 22 | 701.6 Titer |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies | A/Darwin/9/2021 (H3N2), Day 22 | 205.3 Titer |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies | B/Austria/1359417/2021, Day 22 | 903.6 Titer |
Secondary
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.
Time frame: At Day 22 (compared with Baseline [Day 1])
Population: PPS population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Mean Geometric Increase (MGI) of Serum HI Antibodies | A/Victoria/4897/2022 (H1N1) | 17.6 Fold increase |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Mean Geometric Increase (MGI) of Serum HI Antibodies | A/Darwin/9/2021 (H3N2) | 10.2 Fold increase |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Mean Geometric Increase (MGI) of Serum HI Antibodies | B/Austria/1359417/2021 | 9.0 Fold increase |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Mean Geometric Increase (MGI) of Serum HI Antibodies | B/Phuket/3073/2013 | 7.5 Fold increase |
Secondary
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
Population: PPS population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Number of Participants With Seroconversion Rate (SCR) | A/Victoria/4897/2022 (H1N1) | 169 Participants |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Number of Participants With Seroconversion Rate (SCR) | A/Darwin/9/2021 (H3N2) | 160 Participants |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Number of Participants With Seroconversion Rate (SCR) | B/Austria/1359417/2021 | 173 Participants |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Number of Participants With Seroconversion Rate (SCR) | B/Phuket/3073/2013 | 162 Participants |
Secondary
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
Population: PPS population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Number of Participants With Seroprotection Rate (SPR) | A/Victoria/4897/2022 (H1N1), Day 1 | 40 Participants |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Number of Participants With Seroprotection Rate (SPR) | A/Victoria/4897/2022 (H1N1), Day 22 | 180 Participants |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Number of Participants With Seroprotection Rate (SPR) | A/Darwin/9/2021 (H3N2), Day 1 | 69 Participants |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Number of Participants With Seroprotection Rate (SPR) | A/Darwin/9/2021 (H3N2), Day 22 | 187 Participants |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Number of Participants With Seroprotection Rate (SPR) | B/Austria/1359417/2021, Day 1 | 182 Participants |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Number of Participants With Seroprotection Rate (SPR) | B/Austria/1359417/2021, Day 22 | 209 Participants |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Number of Participants With Seroprotection Rate (SPR) | B/Phuket/3073/2013, Day 1 | 186 Participants |
| Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Number of Participants With Seroprotection Rate (SPR) | B/Phuket/3073/2013, Day 22 | 210 Participants |