The study is divided into 2 parts (Part A and Part B). Part A of the study will evaluate the safety and immune response to mRNA-1345 in high-risk adults aged ≥18 to \<60 years. Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,153
Sterile liquid for injection
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Day 1 through Day 7 (7 days post injection) for Part A and Day 1 through Day 64 (7 days post second injection) for Part B
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Day 1 through Day 28 (28 days post injection) for Part A and Day 1 through Day 84 (28 days post second injection) for Part B
Number of Participants With Medically Attended AEs (MAAEs)
Time frame: Day 1 through Month 6 (for Part A) and Day 1 through Month 9 (for Part B)
Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation
Time frame: Day 1 through End of Study (Day 730)
Part A: Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (Abs) at Day 29
Time frame: Day 29
Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 85
Time frame: Day 85
Part A: Seroresponse Rate (SRR) of RSV-A and RSV-B Neutralizing Abs on Day 29
Time frame: Day 29
Part A: Geometric Mean Concentration (GMC) of Serum RSV Prefusion Conformation of the F Protein (Pre-F) Binding Abs
Time frame: Up to End of Study (Day 730)
Part A: Geometric Mean Fold-Rise (GMFR) of Serum RSV Pre-F Binding Abs
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Lenzmeier Family Medicine - CCT - PPDS
Glendale, Arizona, United States
Foothills Research Center - CCT - PPDS
Phoenix, Arizona, United States
Fiel Family & Sports Medicine - PC - CCT - PPDS
Tempe, Arizona, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS
San Diego, California, United States
Critical Care, Pulmonary and Sleep Associates / CCT Research
Lakewood, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Excel Medical Clinical Trials DBA Flourish
Boca Raton, Florida, United States
Indago Research and Health Center
Hialeah, Florida, United States
...and 34 more locations
Time frame: Up to End of Study (Day 730)
Part A: SRR of Serum RSV Pre-F Binding Abs at Postbaseline/Baseline Levels
Time frame: Baseline up to Day 730
Part A: Number of Participants with ≥2-Fold Increase in RSV Pre-F Binding Abs
Time frame: Up to End of Study (Day 730)
Part A: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29
Time frame: Day 29
Part A: GMT of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs
Time frame: Baseline up to Day 730
Part A: GMFR of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs
Time frame: Baseline up to Day 730
Part A: SRR of Serum RSV-A and RSV-B Neutralizing Abs
Time frame: Up to End of Study (Day 730)
Part A: Number of Participants with ≥2-Fold Increase in RSV-A and RSV-B Neutralizing Abs Titers
Time frame: Up to End of Study (Day 730)
Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29
Time frame: Day 29
Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 29
Time frame: Day 29
Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 85
Time frame: Day 85
Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs
Time frame: Up to End of Study (Day 730)
Part B: GMFR of Serum RSV-A and RSV-B Neutralizing Abs
Time frame: Up to End of Study (Day 730)
Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs at Postbaseline/Baseline Levels
Time frame: Baseline up to Day 730
Part B: Number of Participants with ≥2-Fold Increase in RSV-A and RSV-B Neutralizing Abs
Time frame: Up to End of Study (Day 730)
Part B: GMC of Serum RSV Pre-F Binding Abs
Time frame: Up to End of Study (Day 730)
Part B: GMFR of Serum RSV Pre-F Binding Abs
Time frame: Up to End of Study (Day 730)
Part B: SRR of Serum RSV Pre-F Binding Abs at Postbaseline/Baseline Levels
Time frame: Baseline up to End of Study (Day 730)
Part B: Number of Participants with ≥2-Fold Increase in RSV Pre-F Binding Abs
Time frame: Up to End of Study (Day 730)