The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months. The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.
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Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Timeframe: Up to 7 days after each injection
Number of Participants with Unsolicited Adverse Events (AEs)
Timeframe: Up to 28 days after each injection
Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interests (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Withdrawal
Timeframe: Up to BD Day 181
Vaccine Efficacy (VE) of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 2 or More Symptoms
Timeframe: From 14 days postinjection up to 12 months postinjection
VE of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 3 or More Symptoms
Timeframe: From 14 days postinjection up to 12 months postinjection
Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies
Timeframe: BD Day 29
Geometric Mean Ratio (GMR) of Serum RSV-A and RSV-B Neutralizing Antibodies After BD Compared to After Initial Dose
Timeframe: BD Day 29