The purpose of this study is to find and confirm the dose and asses the reactogenicity, safety and immune response of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine (GSK4382276A) candidates administered in healthy younger and older adults (OA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,275
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Assessed solicited administration site events included pain, redness (Erythema), swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Time frame: Day 1 to Day 7
Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever (defined as axillary temperature greater than or equal to (\>=) 38.0°C/100.4°F), chills, headache, fatigue, myalgia, and arthralgia. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Time frame: Day 1 to Day 7
Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Time frame: Day 1 to Day 28
Number of Participants Reporting Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Time frame: Day 1 to Day 183
Number of Participants Reporting AEs of Special Interest (AESIs)
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Study intervention was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Control vaccine was administered intramuscularly in Phase 1, at Day 1.
Study intervention was administered intramuscularly in Phase 2, at Day 1.
Study intervention was administered intramuscularly in Phase 2, at Day 1.
Study intervention was administered intramuscularly in Phase 2, at Day 1.
Control vaccine was administered intramuscularly in Phase 2, at Day 1.
Study intervention was administered intramuscularly in Phase 2, at Day 1.
Control vaccine was administered intramuscularly in Phase 2, at Day 1.
Study intervention was administered intramuscularly in Phase 1, at Day 1.
GSK Investigational Site
Hialeah, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Valparaiso, Indiana, United States
GSK Investigational Site
Lenexa, Kansas, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Dearborn, Michigan, United States
GSK Investigational Site
Papillion, Nebraska, United States
...and 31 more locations
The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Time frame: Day 1 to Day 183
Number of Participants Reporting Medically Attended Events (MAEs)
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physician's office visits, emergency room visits or hospitalization). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Time frame: Day 1 to Day 183
Number of Participants Reporting a Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 8 for Hematology, and Clinical Chemistry
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
Time frame: At Day 8 compared to baseline (Day 1)
Number of Participants Reporting a Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 29 for Hematology, and Clinical Chemistry
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
Time frame: At Day 29 compared to baseline (Day 1)
Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: At Day 29
Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers From Day 1 to Day 29
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: From Day 1 (baseline) to Day 29
Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer \< 1:10 and a post-dose anti-vaccine antibody titer \>= 1:40 or a pre-dose anti-vaccine antibody titer \>= 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: From Day 1 to Day 29
Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer \>= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: At Day 1
Percentage of Participants With Antigen 1 Antibody SPR
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: At Day 29
GMT of Antigen 2 Antibody Titer
Time frame: At Day 29
GMI of Antigen 2 Antibody Titer From Day 1 to Day 29
Time frame: From Day 1 (baseline) to Day 29
Percentage of Participants With Antigen 2 Antibody SCR
Time frame: From Day 1 to Day 29
GMT of Antigen 1 Antibody Titer
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: At Day 92
GMT of Antigen 1 Antibody Titer
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: At Day 183
GMI of Antigen 1 Antibody Titer From Day 1 to Day 92
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: From Day 1 (baseline) to Day 92
GMI of Antigen 1 Antibody Titer From Day 1 to Day 183
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: From Day 1 (baseline) to Day 183
Percentage of Participants With Antigen 1 Antibody SPR
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Time frame: At Day 183
GMT of Antigen 2 Antibody Titer
Time frame: At Day 92 and Day 183
GMI of Antigen 2 Antibody Titer
Time frame: From Day 1 to Day 92 and Day 1 to Day 183