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).
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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
Timeframe: 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
Timeframe: Day 29
Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 85
Timeframe: Day 85