RecruitingInfluenza, Human

A Study on the Efficacy of a Vaccine Against Influenza in Adults ≥65 Years of Age

Eligible age

65+ yrs

Accepts

All genders

Locations

34 states

Healthy volunteers

Yes

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About this study

This study will compare an investigational mRNA flu vaccine with a licensed flu vaccine in adults 65 years of age and older. Participants will receive one injection and will be followed during the flu season. The study will measure prevention of laboratory-confirmed flu illness, side effects, and immune responses.

Sponsor: GlaxoSmithKline

You may qualify if…

✓ 1. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol independently or with the assistance of a caregiver.
✓ 2. Written or witnessed (physically or digitally) informed consent obtained from the participant/Legally acceptable representative \[LAR(s)\] of the participant prior to performance of any study-specific procedure.
✓ 3. Healthy participants or medically stable patients as established by medical history and clinical examination. Participants with chronic medical conditions with or without specific treatment 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 enrollment.
✓ 4. A male or female participant at least 65 YOA at the time of the study intervention administration.

You may not qualify if…

✕ 1. History of test-confirmed influenza infection within 180 days prior to study intervention administration.
✕ 2. Any confirmed or suspected immunosuppressive or immunodeficient condition. HIV-infected individuals may be enrolled if they have been stable on antiretroviral therapy for the past 6 consecutive months, their CD4 cell count is ≥ 200/mm³ and their viral load has been undetectable.
✕ 3. Hypersensitivity to latex.
✕ 4. History of myocarditis or pericarditis considered causally associated with mRNA vaccine.
✕ 5. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
✕ 6. History of hypersensitivity or allergic reaction to any previous influenza vaccine.
✕ 7. History of hypersensitivity or allergic reaction to any previous mRNA vaccine.
✕ 8. History of Guillain-Barré syndrome (GBS) within 6 weeks of receiving any vaccine.