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 range18 Years – 85 Years
SexALL
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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.
✓. 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.
✕
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
. 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).