The purpose of this study is to assess the reactogenicity, safety and immune response of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine candidates administered in healthy younger and older adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
971
One dose of Flu mRNA (Formulation B1) received intramuscularly.
One dose of Flu mRNA (Formulation B3) received intramuscularly.
One dose of Flu mRNA (Formulation A) received intramuscularly.
GSK Investigational Site
Guntersville, Alabama, United States
GSK Investigational Site
Canoga Park, California, United States
Geometric Mean Titer (GMT) Of Antigen 1 Titer
Time frame: At Day 29
Geometric Mean Increase (GMI) of Antigen 1 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 Seroprotection Rate (SPR)
Time frame: At Day 1 and Day 29
Number of Participants with Solicited Administration Site Adverse Events (AEs)
The solicited administration site AEs considered are pain, redness, swelling and lymphadenopathy.
Time frame: From Day 1 to Day 7
Number of Participants with Solicited Systemic AEs
The solicited systemic AEs considered are fever, headache, fatigue, myalgia, arthralgia and chills. Fever is defined as temperature greater than or equal to (\>=) 38 °C/100.4 °F regardless the location of measurement.
Time frame: From Day 1 to Day 7
Number of Participants with Unsolicited AEs
An unsolicited AE is 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.
Time frame: From Day 1 to Day 28
Number of Participants with Serious Adverse Events (SAEs)
SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment.
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One dose of Comparator 1 received intramuscularly.
One dose of Comparator 2 received intramuscularly.
One dose of Comparator 3 received intramuscularly.
GSK Investigational Site
Walnut Creek, California, United States
GSK Investigational Site
Hialeah, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Pembroke Pines, Florida, United States
GSK Investigational Site
Stockbridge, Georgia, United States
GSK Investigational Site
Carson City, Nevada, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Greensboro, North Carolina, United States
...and 7 more locations
Time frame: From Day 1 to Day 181 (study end)
Number of Participants with Adverse Events of Special Interest (AESIs)
Time frame: From Day 1 to Day 181 (study end)
Number of Participants with Medically Attended Adverse Events (MAAEs)
A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.
Time frame: From Day 1 to Day 181 (study end)
Number of Participants with any Laboratory abnormalities
Time frame: From Day 1 to Day 29
GMT Ratio of Antigen 2 Titer
Time frame: At Day 29
GMI of Antigen 2 Titer
Time frame: From Day 1 to Day 29
Percentage of Participants with Antigen 2 SCR
Time frame: From Day 1 to Day 29