The purpose of this study is to evaluate the immunogenicity, reactogenicity, and safety, of mRNA-1083 multicomponent influenza and COVID-19 vaccine in adults ≥18 to \<65 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,320
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Headlands Research Scottsdale
Scottsdale, Arizona, United States
Artemis Research (Headlands)
San Diego, California, United States
Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza
Time frame: Day 29
Geometric Mean Concentration (GMC) as Measured by Pseudovirus Neutralization Assay (PsVNA) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Time frame: Day 29
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Day 1 through 7 days after study injection
Number of Participants With Unsolicited Adverse Events (AEs)
Time frame: Day 1 through 28 days after study injection
Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation From the Study
Time frame: Day 1 through Day 181
Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza as Measured by HAI Assay
Time frame: Baseline (Day 1), Day 29
GMFR of Antibodies for SARS-CoV-2 as Measured by PsVNA
Time frame: Baseline (Day 1), Day 29
Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay
Seroconversion is defined as postinjection level ≥1:40 if baseline is \<1:10 or at least a 4-fold rise if baseline is ≥1:10 in HAI antibody titer.
Time frame: Baseline (Day 1) to Day 29
SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Clinical Research Atlanta (Headlands)
Stockbridge, Georgia, United States
Velocity Clinical Research, Boise
Meridian, Idaho, United States
DM Clinical Research - Chicago
Melrose Park, Illinois, United States
Velocity Clinical Research, Lafayette
Lafayette, Louisiana, United States
Velocity Clinical Research, Rockville
Rockville, Maryland, United States
DM Clinical Research - Boston
Brookline, Massachusetts, United States
DM Clinical Research - Detroit
Southfield, Michigan, United States
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, United States
...and 7 more locations
Seroresponse is defined as PsVNA concentration change from preinjection baseline below the lower limit of quantification (LLOQ) to postinjection ≥4×LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ.
Time frame: Baseline (Day 1) to Day 29