Created at Source Raw Value Validated value
June 25, 2024, noon usa

part 1 (phase 1/2) and part 2 (phase 2 extension) * participant is acutely ill or febrile (temperature ≥38.0 degrees celsius \[°c\]/100.4 degrees fahrenheit \[°f\]) 72 hours prior to or at the screening visit or day 1. * any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the clinical trial or could interfere with the interpretation of study results. * participant has received systemic immunosuppressants for \>14 days in total within 180 days prior to screening visit (for glucocorticoids ≥10 milligrams \[mg\]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). inhaled, nasal, and topical steroids are allowed. * participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration. * participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to day 1. * participant tested positive for influenza by local health authority-approved testing methods ≤150 days prior to day 1. * participant has had close contact to someone with covid-19 as defined by the centers for disease control and prevention (cdc) in the past 10 days prior to day 1. * participant has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit or plans to donate blood products during the clinical trial. * working or has worked as study personnel, is an immediate family member or household member of study personnel, study site staff, or sponsor personnel, or resides in a nursing home. part 2 (phase 2 extension) only * participants who enrolled in part 1 of the mrna-1083-p101 (phase 1/2) study. note: other inclusion/exclusion criteria may apply.

part 1 (phase 1/2) and part 2 (phase 2 extension) * participant is acutely ill or febrile (temperature ≥38.0 degrees celsius \[°c\]/100.4 degrees fahrenheit \[°f\]) 72 hours prior to or at the screening visit or day 1. * any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the clinical trial or could interfere with the interpretation of study results. * participant has received systemic immunosuppressants for \>14 days in total within 180 days prior to screening visit (for glucocorticoids ≥10 milligrams \[mg\]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). inhaled, nasal, and topical steroids are allowed. * participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration. * participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to day 1. * participant tested positive for influenza by local health authority-approved testing methods ≤150 days prior to day 1. * participant has had close contact to someone with covid-19 as defined by the centers for disease control and prevention (cdc) in the past 10 days prior to day 1. * participant has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit or plans to donate blood products during the clinical trial. * working or has worked as study personnel, is an immediate family member or household member of study personnel, study site staff, or sponsor personnel, or resides in a nursing home. part 2 (phase 2 extension) only * participants who enrolled in part 1 of the mrna-1083-p101 (phase 1/2) study. note: other inclusion/exclusion criteria may apply.

May 22, 2024, 4 p.m. usa

part 1 (phase 1/2) and part 2 (phase 2 extension) participant is acutely ill or febrile (temperature ≥38.0 degrees celsius [°c]/100.4 degrees fahrenheit [°f]) 72 hours prior to or at the screening visit or day 1. any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the clinical trial or could interfere with the interpretation of study results. participant has received systemic immunosuppressants for >14 days in total within 180 days prior to screening visit (for glucocorticoids ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). inhaled, nasal, and topical steroids are allowed. participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration. participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to day 1. participant tested positive for influenza by local health authority-approved testing methods ≤150 days prior to day 1. participant has had close contact to someone with covid-19 as defined by the centers for disease control and prevention (cdc) in the past 10 days prior to day 1. participant has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit or plans to donate blood products during the clinical trial. working or has worked as study personnel, is an immediate family member or household member of study personnel, study site staff, or sponsor personnel, or resides in a nursing home. part 2 (phase 2 extension) only participants who enrolled in part 1 of the mrna-1083-p101 (phase 1/2) study. note: other inclusion/exclusion criteria may apply.

part 1 (phase 1/2) and part 2 (phase 2 extension) participant is acutely ill or febrile (temperature ≥38.0 degrees celsius [°c]/100.4 degrees fahrenheit [°f]) 72 hours prior to or at the screening visit or day 1. any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the clinical trial or could interfere with the interpretation of study results. participant has received systemic immunosuppressants for >14 days in total within 180 days prior to screening visit (for glucocorticoids ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). inhaled, nasal, and topical steroids are allowed. participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration. participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to day 1. participant tested positive for influenza by local health authority-approved testing methods ≤150 days prior to day 1. participant has had close contact to someone with covid-19 as defined by the centers for disease control and prevention (cdc) in the past 10 days prior to day 1. participant has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit or plans to donate blood products during the clinical trial. working or has worked as study personnel, is an immediate family member or household member of study personnel, study site staff, or sponsor personnel, or resides in a nursing home. part 2 (phase 2 extension) only participants who enrolled in part 1 of the mrna-1083-p101 (phase 1/2) study. note: other inclusion/exclusion criteria may apply.

April 27, 2023, 4 a.m. usa

participant is acutely ill or febrile (temperature ≥38.0 degrees celsius [°c]/100.4 degrees fahrenheit [°f]) 72 hours prior to or at the screening visit or day 1. any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the clinical trial or could interfere with the interpretation of study results. participant has received systemic immunosuppressants for >14 days in total within 180 days prior to screening visit (for glucocorticoids ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). inhaled, nasal, and topical steroids are allowed. participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration. participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to day 1. participant tested positive for influenza by local health authority-approved testing methods ≤150 days prior to day 1. participant has had close contact to someone with covid-19 as defined by the centers for disease control and prevention (cdc) in the past 10 days prior to day 1. participant has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit or plans to donate blood products during the clinical trial. note: other inclusion/exclusion criteria may apply.

participant is acutely ill or febrile (temperature ≥38.0 degrees celsius [°c]/100.4 degrees fahrenheit [°f]) 72 hours prior to or at the screening visit or day 1. any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the clinical trial or could interfere with the interpretation of study results. participant has received systemic immunosuppressants for >14 days in total within 180 days prior to screening visit (for glucocorticoids ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). inhaled, nasal, and topical steroids are allowed. participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration. participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to day 1. participant tested positive for influenza by local health authority-approved testing methods ≤150 days prior to day 1. participant has had close contact to someone with covid-19 as defined by the centers for disease control and prevention (cdc) in the past 10 days prior to day 1. participant has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit or plans to donate blood products during the clinical trial. note: other inclusion/exclusion criteria may apply.