COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05827926

Moderna Clinical Trials Support Center

clinicaltrials@modernatx.com

2023-04-25

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

key inclusion criteria: body mass index (bmi) of 18 kilograms (kg)/m2 to 35 kg/square meter (m^2) (inclusive) at the screening visit. healthy as determined by medical evaluation, including medical history, physical examination, and laboratory tests. for female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to day 1, agreement to continue adequate contraception through 90 days following vaccine administration, and not currently breastfeeding. fully vaccinated for covid-19 primary series according to the locally authorized or approved regimen, and their last covid-19 vaccine (primary series or booster) was ≥120 days prior to day 1. key

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.

24

ModernaTX, Inc.

18

79

United States

Healthy volunteers

N/A

1224

Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs);Number of Participants With Unsocilited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation of Study;Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs

None

Phase 1/Phase 2

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