A Study to Find the Dose and Assess the Immune Response and Safety of a Vaccine Against Influenza… (NCT06431607) | Clinical Trial Compass
CompletedPhase 2
A Study to Find the Dose and Assess the Immune Response and Safety of a Vaccine Against Influenza in Healthy Younger and Older Adults
United States845 participantsStarted 2024-05-23
Plain-language summary
The purpose of this study is to assess the safety and immune response of GlaxoSmithKlines (GSK) messenger RNA (mRNA)-based multivalent vaccine (GSK4382276A) candidate against influenza, administered in healthy younger adults (YA) and older adults (OA).
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. A male or female between and including 18 and 85 years of age (YAs: 18-64; OAs: 65-85) at the time of the study intervention administration.
. Healthy participants or medically stable patients as established by medical history and clinical examination. Participants with chronic medical conditions with or without specific treatment (e.g., chronic metabolic, cardiac, pulmonary, renal, hepatic, neurologic, and hematologic diseases) are allowed to participate in this study if considered by the investigator as medically stable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrolment.
. Body mass index (BMI) \>=18 Kilograms per meter square (kg/m²) and less than or equal to (\<=) 35kg/m2.
. Participants 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), independently or with the assistance of a caregiver.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1 YA: Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Timeframe: At Day 29
2
Part 2 YA: GMT of Antigen 1 Antibody Titer
Timeframe: At Day 29
3
Part 1 OA: GMT of Antigen 1 Antibody Titer
Timeframe: At Day 29
4
Part 2 OA: GMT of Antigen 1 Antibody Titer
Timeframe: At Day 29
5
Part 1 YA: Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers
. Written informed consent obtained from the participant prior to performance of any study-specific procedure.
. Female participants of non-childbearing potential may be enrolled in the clinical study.
. Female participants of childbearing potential may be enrolled in the clinical study, if the participant:
Exclusion criteria
. Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1.
. Current or past malignancy, unless completely resolved without sequelae for greater than (\>) 5 years before the study intervention administration (excluding effectively treated basal cell skin cancer).
. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required). HIV-infected individuals may be enrolled if they have been stable on antiretroviral therapy for the past 6 consecutive months, i.e., their treatment has not been modified, their cluster of differentiation 4 (CD4) cell count is \>= 200/ cubic millimeter (mm³) and their viral load has been undetectable (i.e., HIV-RNA lesser than (\<) 50 copies/milliliter \[mL\]) (based on medical records, no laboratory testing required).
. Participants with a history of, or current suspicion of myocarditis, pericarditis, or idiopathic cardiomyopathy (including a history of myocarditis or pericarditis following vaccination with an mRNA COVID-19 vaccine), or presence of any medical condition that increases risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection will be excluded from the study.
. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention (including polyethylene glycol, egg proteins and aminoglycoside antibiotics).
. Hypersensitivity to latex.
. Recurrent history or uncontrolled neurological disorders or seizures, including Guillain-Barré syndrome and Bell's palsy, with the exception of febrile seizures during childhood.
. Any history of dementia or any medical condition that moderately or severely impairs cognition.
Part 2 OA: GMI of Antigen 1 Antibody Titers
Timeframe: From Day 1 (baseline) to Day 29
9
Part 1 YA: Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
Timeframe: From Day 1 (baseline) to Day 29
10
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SCR
Timeframe: From Day 1 (baseline) to Day 29
11
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SCR
Timeframe: From Day 1 (baseline) to Day 29
12
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SCR
Timeframe: From Day 1 (baseline) to Day 29
13
Part 1 YA: Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
Timeframe: At Day 1
14
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SPR
Timeframe: At Day 1
15
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SPR
Timeframe: At Day 1
16
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SPR
Timeframe: At Day 1
17
Part 1 YA: Percentage of Participants With Antigen 1 Antibody SPR
Timeframe: At Day 29
18
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SPR
Timeframe: At Day 29
19
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SPR
Timeframe: At Day 29
20
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SPR