A Clinical Study to Investigate the Safety and Immunogenicity in Relation to Product Attributes of mRNA-1083 (Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2] and Influenza Vaccine)
NCT Number: NCT06508320
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Influenza|SARS-CoV-2
Interventions: BIOLOGICAL: mRNA-1083
Sponsor: ModernaTX, Inc.
Sex: ALL
Age: ADULT
Enrollment: 619
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-15
Completion Date: 2025-02-13
Locations: Indago Research & Health Center, Inc., Hialeah, Florida, 33012, United States|Cenexel RCA, Hollywood, Florida, 33024, United States|Suncoast Research Group, LLC DBA Flourish Research, Miami, Florida, 33135, United States|Cenexel IRA, Decatur, Georgia, 30030, United States|DM Clinical Research - River Forest, River Forest, Illinois, 60305, United States|JCCT, Lenexa, Kansas, 66219, United States|DM Clinical Research - Philadelphia, Philadelphia, Pennsylvania, 19107, United States|Clinical Trials of Texas, LLC DBA Flourish Research, San Antonio, Texas, 78229, United States|DM Clinical Research - Sugarland, Sugar Land, Texas, 77478, United States|DM Clinical Research - Tomball MDC, Tomball, Texas, 77375, United States|Centricity Research, Toronto, Ontario, M4G 3E8, Canada|Centricity Research, Toronto, Ontario, M9W 4L6, Canada|Centricity Research, Pointe-Claire, Quebec, H9R4S3, Canada|Diex Recherche Sherbrooke Inc., Sherbrooke, Quebec, J1L 0H8, Canada|Diex Recherche Québec Inc., Québec, G1V 4T3, Canada

Summary:
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.

Primary Outcome Measures: Geometric Mean Value of Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay for Influenza, Day 29|Geometric Mean Value of Antibodies at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) for SARS-CoV-2, Day 29|Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs), Up to Day 7 (7 days after vaccination)|Number of Participants with Unsolicited Adverse Events (AEs), Up to Day 28 (28 days after vaccination)|Number of Participants with Medically Attended Adverse Events (MAAEs), Up to Day 181|Number of Participants with Adverse Events of Special Interest (AESIs), Up to Day 181|Number of Participants with Serious Adverse Events (SAEs), Up to Day 181|Number of Participants with AEs Leading to Discontinuation from Study Participation, Up to Day 181
Secondary Outcome Measures: Geometric Mean Fold Rise (GMFR) of Antibodies at Day 29 Relative to Day 1, as Measured by HAI Assay for Influenza, Day 1, Day 29|GMFR of Antibodies at Day 29 Relative to Day 1, as Measured by PsVNA for SARS-CoV-2, Day 1, Day 29|Seroconversion Rate (SCR) in Anti-hemagglutinin (HA) Antibody Values at Day 29, as Measured by HAI Assay for Influenza, Day 29|Seroresponse Rate (SRR) in Neutralizing Antibody (nAb) Values at Day 29, as Measured by PsVNA for SARS-CoV-2, Day 29