The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity in relation to the product attributes of mRNA-1083 vaccine when administered as a single intramuscular (IM) injection in adults ≥50 to \<65 years of age.
The study will be comprised of 2 parts, Parts 1 and 2. In Part 1, participants will be randomized into 4 study groups (Lots A, B, C, and D). Upon completion of Part 1, participants will be randomized into 2 study groups (Lots A and E) in Part 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
932
IM injection in a deltoid muscle.
Indago Research & Health Center, Inc.
Hialeah, Florida, United States
Cenexel RCA
Hollywood, Florida, United States
Geometric Mean Value of Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay for Influenza
Time frame: Day 29
Geometric Mean Value of Antibodies at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) for SARS-CoV-2
Time frame: Day 29
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 7 (7 days after vaccination)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 28 (28 days after vaccination)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Time frame: Up to Day 181
Number of Participants with Adverse Events of Special Interest (AESIs)
Time frame: Up to Day 181
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to Day 181
Number of Participants with AEs Leading to Discontinuation from Study Participation
Time frame: Up to Day 181
Geometric Mean Fold Rise (GMFR) of Antibodies at Day 29 Relative to Day 1, as Measured by HAI Assay for Influenza
Time frame: Day 1, Day 29
GMFR of Antibodies at Day 29 Relative to Day 1, as Measured by PsVNA for SARS-CoV-2
Time frame: Day 1, Day 29
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Suncoast Research Group, LLC DBA Flourish Research
Miami, Florida, United States
Cenexel IRA
Decatur, Georgia, United States
DM Clinical Research - River Forest
River Forest, Illinois, United States
JCCT
Lenexa, Kansas, United States
Hassman Research Institute - Berlin - CenExel - PPDS
Marlton, New Jersey, United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, United States
DM Clinical Research - Cyfair Clinical Research Center - PPDS
Houston, Texas, United States
Clinical Trials of Texas, LLC DBA Flourish Research
San Antonio, Texas, United States
...and 7 more locations
Seroconversion Rate (SCR) in Anti-hemagglutinin (HA) Antibody Values at Day 29, as Measured by HAI Assay for Influenza
Time frame: Day 29
Seroresponse Rate (SRR) in Neutralizing Antibody (nAb) Values at Day 29, as Measured by PsVNA for SARS-CoV-2
Time frame: Day 29