A Study to Assess the Immune Response and Safety of a Vaccine Against Influenza in Adults 18 Year… (NCT07121192) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Assess the Immune Response and Safety of a Vaccine Against Influenza in Adults 18 Years of Age and Older
United States776 participantsStarted 2025-08-25
Plain-language summary
"The purpose of this study is to assess the reactogenicity, safety and immune response of GlaxoSmithKlines (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine candidates administered in healthy younger and older adults."
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, attendance to study contacts and study site visits, and ability to access and utilize a phone or other electronic communications) independently or with the assistance of a caregiver.
✓. Written (physically, or digitally) informed consent obtained from the participant prior to performance of any study-specific procedure.
✓. A male or female at least 18 YOA at the time of the screening.
✓. 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, 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 enrollment.
✓. 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:
✓. Body mass index (BMI) between18 kg/m\^² and 33kg/m\^².
Exclusion criteria
✕. Where applicable, FDA toxicity grades will be exclusionary.
✕. Immunosuppressive or immunodeficient conditions by history/exam; stable HIV-positive individuals on therapy can participate.
What they're measuring
1
Geometric Mean Titer (GMT) Ratio of Antigen 1 Titer
Timeframe: At Day 29
2
Geometric Mean Increase (GMI) of Antigen 1 Titer
Timeframe: From Day 1 to Day 29
3
Percentage of Participants with Antigen 1 Seroconversion Rate (SCR)
Timeframe: From Day 1 to Day 29
4
Percentage of Participants with Antigen 1 Seroprotection Rate (SPR)
Timeframe: At Day 1 and Day 29
5
Number of Participants with Solicited Administration Site Adverse Events (Aes)
Timeframe: From Day 1 to Day 7
6
Number of Participants with Solicited Systemic Aes
Timeframe: From Day 1 to Day 7
7
Number of Participants with Unsolicited Aes
Timeframe: From Day 1 to Day 28
8
Number of Participants with Serious Adverse Events (SAEs)
✕. Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 1 year).
✕. Hypersensitivity to latex.
✕. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
✕. History of hypersensitivity or severe allergic reaction to any previous influenza vaccine.
✕. History of hypersensitivity or severe allergic reaction to any previous mRNA vaccine.
9
Number of Participants with Adverse Events of Special Interest (AESIs)
Timeframe: From Day 1 to Day 181 (study end)
10
Number of Participants with Medically Attended Adverse Events (MAAEs)
Timeframe: From Day 1 to Day 181 (study end)
11
Number of Participants with any Laboratory abnormalities