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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
54,000
Single-dose intramuscular administration of the season-adapted investigational mRNA Seasonal Flu vaccine.
Single-dose intramuscular administration of an age-appropriate and season-adapted licensed influenza vaccine used as the active comparator.
Laboratory-confirmed protocol-defined influenza-like illness (ILI) assessed by incidence rate ratio
First occurrence of laboratory-confirmed protocol-defined ILI caused by influenza A subtypes and B lineage. Protocol-defined ILI is defined as the simultaneous occurrence of at least 1 respiratory symptom and at least 1 systemic symptom. Respiratory symptoms include nasal congestion, sore throat, new or increased sputum, new or increased cough, new or increased dyspnea, or wheezing. Systemic symptoms include temperature \>37.2°C/99°F or feverishness, fatigue, myalgia, or headache. The endpoint will be assessed using an incidence rate approach. Relative vaccine efficacy will be calculated as 100 × (1 - incidence rate ratio).
Time frame: From Day 15 through the end of the influenza Season
Number of Participants with Solicited Administration Site Adverse Events (AEs)
The solicited administration site AEs considered are pain, redness, swelling and lymphadenopathy. Lymphadenopathy is defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm.
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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GSK Investigational Site
Anniston, Alabama, United States
RECRUITINGGSK Investigational Site
Guntersville, Alabama, United States
RECRUITINGGSK Investigational Site
Glendale, Arizona, United States
RECRUITINGGSK Investigational Site
Mesa, Arizona, United States
RECRUITINGGSK Investigational Site
Mesa, Arizona, United States
RECRUITINGGSK Investigational Site
Phoenix, Arizona, United States
RECRUITINGGSK Investigational Site
Phoenix, Arizona, United States
RECRUITINGGSK Investigational Site
Scottsdale, Arizona, United States
RECRUITINGGSK Investigational Site
Scottsdale, Arizona, United States
RECRUITINGGSK Investigational Site
Sun City, Arizona, United States
RECRUITING...and 153 more locations
Time frame: From Day 1 up to the end of the influenza season (with at least 180 days of follow-up)
Number of Participants with Adverse Events of Special Interest (AESIs)
An adverse event of special interest is an adverse event of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor may be appropriate. AESIs include protocol-defined events such as potential immune-mediated disorders, myocarditis, pericarditis, severe hypersensitivity reactions, and other AESIs defined in the protocol.
Time frame: From Day 1 up to the end of the influenza season (with at least 180 days of follow-up)
Number of Participants with any Laboratory abnormalities
Time frame: At Day 1 (pre-dose) and at Day 29 (post -dose)
Laboratory-confirmed protocol-defined ILI assessed for relative vaccine efficacy by incidence rate ratio
First occurrence of laboratory-confirmed protocol-defined ILI caused by influenza A subtypes and B lineage. This endpoint will assess the incidence rate of the investigational mRNA Seasonal Flu vaccine compared with the licensed influenza vaccine comparator.
Time frame: From Day 15 through the end of the influenza Season
Severe Influenza Disease (SID) assessed by incidence rate ratio
First occurrence of severe influenza disease caused by influenza A or B. Severe influenza disease includes serious influenza-related outcomes such as pneumonia, hospitalization, or death associated with laboratory-confirmed influenza.
Time frame: From Day 15 through the end of the influenza Season
Laboratory-confirmed Centers for Disease Control and Prevention-defined ILI assessed by incidence rate ratio
First occurrence of laboratory-confirmed Centers for Disease Control and Prevention-defined ILI caused by influenza A subtypes and B lineage.
Time frame: From Day 15 through the end of the influenza Season
Laboratory-confirmed modified Centers for Disease Control and Prevention-defined ILI assessed by incidence rate ratio
First occurrence of laboratory-confirmed modified Centers for Disease Control and Prevention-defined ILI caused by influenza A subtypes and B lineage.
Time frame: From Day 15 through the end of the influenza Season
Laboratory-confirmed protocol-defined ILI by antigenic matching status
First occurrence of laboratory-confirmed protocol-defined ILI caused by influenza viruses considered antigenically matched, non-matched, or of unknown matching status to the vaccine strains.
Time frame: From Day 15 through the end of the influenza Season ,
All-cause protocol-defined ILI assessed by incidence rate ratio
First occurrence of protocol-defined ILI, regardless of cause.
Time frame: From Day 15 through the end of the influenza Season
Influenza-related medically attended event assessed by incidence rate ratio
First occurrence of an influenza-related medically attended event associated with laboratory-confirmed protocol-defined ILI or severe influenza disease.
Time frame: From Day 15 through the end of the influenza Season
Influenza-related oxygen support for more than 24 hours assessed by incidence rate ratio
First occurrence of influenza-related oxygen support for more than 24 hours associated with laboratory-confirmed protocol-defined ILI or severe influenza disease.
Time frame: From Day 15 through the end of the influenza Season
Influenza-related intensive care unit admission assessed by incidence rate ratio
First occurrence of influenza-related intensive care unit admission associated with laboratory-confirmed protocol-defined ILI or severe influenza disease.
Time frame: From Day 15 through the end of the influenza Season
Influenza-related major adverse cardiovascular event assessed by incidence rate ratio
First occurrence of influenza-related major adverse cardiovascular event associated with laboratory-confirmed protocol-defined ILI or severe influenza disease.
Time frame: From Day 15 through the end of the influenza Season
To evaluate the impact of the study interventions on healthcare resource utilization during laboratory-confirmed influenza episodes
Healthcare resource utilization during laboratory-confirmed protocol-defined ILI or severe influenza disease episodes. This includes hospitalization and length of stay, intensive care unit admission and length of stay, emergency room or urgent care visits, general practitioner or specialist visits, medical home visits, physical therapy sessions, use of antibiotics, antiviral medication, oxygen therapy, advanced oxygen support, mechanical ventilation, and number of days missed from work.
Time frame: From Day 15 through the end of the influenza Season
Geometric mean titers (GMT) Ratio of Antigen 1, Antigen 2 and Virus Neutralization Antibody Titers
Time frame: At Day 29
Geometric mean increase (GMI) of Antigen 1, Antigen 2 and Virus Neutralization Antibody Titers
Time frame: From Day 1 to Day 29
Percentage of Participants with Antigen 1, Antigen 2 and Virus Neutralization 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