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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
840
1 dose of Flu mRNA Formulation 1 is administered intramuscularly in the non-dominant upper deltoid to YA participants at Day 1.
1 dose of Flu mRNA Formulation 2 is administered intramuscularly in the non-dominant upper deltoid to YA at Day 1.
1 dose of Flu mRNA Formulation 3 is administered intramuscularly in the non-dominant upper deltoid to YA participants at Day 1.
GSK Investigational Site
Hialeah, Florida, United States
GSK Investigational Site
Miami, Florida, United States
Geometric mean titer (GMT) of antigen 1 antibody
Time frame: At Day 29
Geometric mean increase (GMI) of Antigen 1 antibody titer
Time frame: From Day 1 to Day 29
Percentage of participants with antigen 1 seroconversion rate (SCR)
Time frame: From Day 1 to Day 29
Percentage of participants with antigen 1 titer greater than or equal to (>=) the cut off value at Day 1
Time frame: At Day 1
Percentage of participants with antigen 1 titer >= the cut off value at Day 29
Time frame: At Day 29
GMT of antigen 2 antibody
Time frame: At Day 29
GMI of antigen 2 antibody titer
Time frame: From Day 1 to Day 29
Percentage of participants with Antigen 2 SCR
Time frame: From Day 1 to Day 29
Percentage of participants reporting each solicited administration site event
The following administration site events are solicited: pain, redness, swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm).
Time frame: Day 1 to Day 7
Percentage of participants reporting each solicited systemic event
The following systemic events are solicited: fever, headache, myalgia, arthralgia, fatigue, chills. Fever is defined as temperature \>=38 °C/100.4°F regardless the location of measurement. The route for measuring temperature is oral.
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1 dose of Flu mRNA Formulation 4 is administered intramuscularly in the non-dominant upper deltoid to YA participants at Day 1.
1 dose of Flu mRNA Formulation 5 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1.
1 dose of Flu mRNA Formulation 6 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1.
1 dose of Flu mRNA Formulation 7 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1.
1 dose of Flu mRNA Formulation 8 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1.
1 dose of active comparator 1 is administered intramuscularly in the non-dominant upper deltoid to YA participants at Day 1.
1 dose of active comparator 2 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1.
1 dose of Flu mRNA Formulation 9 is administered intramuscularly in the non-dominant upper deltoid to YA participants at Day 1.
1 dose of Flu mRNA Formulation 10 is administered intramuscularly in the non-dominant upper deltoid to OA participants at Day 1.
1 dose of active comparator 3 is administered intramuscularly in the non-dominant upper deltoid to YA participants at Day 1.
1 dose of active comparator 4 is administered intramuscularly in the non-dominant upper deltoid to OA at Day1.
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Valparaiso, Indiana, United States
GSK Investigational Site
El Dorado, Kansas, United States
GSK Investigational Site
Lenexa, Kansas, United States
GSK Investigational Site
Newton, Kansas, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
Lexington, Kentucky, United States
...and 8 more locations
Time frame: Day 1 to Day 7
Percentage of participants reporting unsolicited adverse events (AEs)
An unsolicited AE is defined as an AE that is 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.
Time frame: Day 1 to Day 28
Percentage 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.
Time frame: Day 1 to Day 183
Percentage of participants reporting adverse events of special interest (AESIs)
The following events are considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs).
Time frame: Day 1 to Day 183
Percentage of participants reporting medically attended adverse events (MAAEs)
A MAAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physicians office visits, emergency room visits or hospitalization).
Time frame: Day 1 to Day 183