Phase
Condition
Covid-19
Influenza
Sars-cov-2
Treatment
COVID-19 Vaccine
Investigational Influenza Vaccine
mRNA-1083 Composition 1 Dose B
Clinical Study ID
Ages 18-64 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Medically stable.
Participants who could become pregnant: negative pregnancy test and contraceptionfor at least 28 days prior to Day 1 and for at least 90 days after the studyintervention administration.
Have received ≥2 coronavirus disease 2019 (COVID-19) vaccines, with the lastCOVID-19 vaccine administered >150 days prior to Day 1.
Exclusion
Exclusion Criteria:
History of a diagnosis or condition that is clinically unstable or may affectparticipant safety, assessment of study endpoints, assessment of immune response, oradherence to study procedures.
Tested positive for influenza by local health authority-approved testing methodswithin 150 days prior to Day 1.
History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infectionwithin 150 days prior to Day 1.
Received systemic immunosuppressive treatment, including long-acting biologicaltherapies that affect immune responses (eg, infliximab), within 180 days prior toDay 1 or plans to do so during the study.
Received or plans to receive any vaccine authorized or approved by a local healthagency within 28 days prior to Day 1 or plans to do so within 28 days post studyinjection.
Received a licensed seasonal influenza vaccine within 150 days prior to Day 1.
Received a licensed/authorized COVID-19 vaccine within 150 days prior to Day 1.
Received any investigational influenza vaccine, investigational COVID-19 vaccine, orinvestigational combination vaccine for influenza and COVID-19 within 12 monthsprior to Day 1.
Participated in a clinical study with investigational treatment within 90 days priorto Day 1 (Baseline).
Other protocol-defined inclusion/exclusion criteria may apply.
Study Design
Connect with a study center
Headlands Research Scottsdale
Scottsdale, Arizona 85260
United StatesSite Not Available
Artemis Research (Headlands)
San Diego, California 92103
United StatesSite Not Available
Clinical Research Atlanta (Headlands)
Stockbridge, Georgia 30281
United StatesSite Not Available
Velocity Clinical Research, Boise
Meridian, Idaho 83642
United StatesSite Not Available
DM Clinical Research - Chicago
Melrose Park, Illinois 60160
United StatesSite Not Available
Velocity Clinical Research, Lafayette
Lafayette, Louisiana 70809
United StatesSite Not Available
Velocity Clinical Research, Rockville
Rockville, Maryland 20854
United StatesSite Not Available
DM Clinical Research - Boston
Brookline, Massachusetts 02446
United StatesSite Not Available
DM Clinical Research - Detroit
Southfield, Michigan 48076
United StatesSite Not Available
Velocity Clinical Research, Norfolk
Norfolk, Nebraska 68701
United StatesSite Not Available
Trial Management Associates, LLC
Wilmington, North Carolina 28403
United StatesSite Not Available
Velocity Clinical Research, Cincinnati, Mt. Auburn
Cincinnati, Ohio 45219
United StatesSite Not Available
Velocity Clinical Research, Cincinnati, Springdale
Cincinnati, Ohio 45246
United StatesSite Not Available
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
Trial Management Associates, LLC
Myrtle Beach, South Carolina 29572
United StatesSite Not Available
DM Clinical Research - Bellaire
Houston, Texas 77081
United StatesSite Not Available
DM Clinical Research - Tomball
Tomball, Texas 77375
United StatesSite Not Available
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