The purpose of the study is to evaluate the reactogenicity, safety, and immunogenicity of an investigational respiratory syncytial virus (RSV) vaccine, mRNA-1345, in pregnant women, and safety and immunogenicity in infants born to vaccinated mothers.
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Number of Maternal Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Timeframe: Up to Day 7 (7 days post vaccination)
Number of Maternal Participants with Unsolicited Adverse Events (AEs)
Timeframe: Up to Day 28 (28 days post vaccination)
Number of Maternal Participants with Medically-Attended AEs (MAAEs)
Timeframe: Day 1 to Month 6 (6 months postdelivery)
Number of Maternal Participants with Adverse Events of Special Interest (AESIs)
Timeframe: Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants with Serious Adverse Events (SAEs)
Timeframe: Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants with AEs Leading to Discontinuation
Timeframe: Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants With Pregnancy Outcomes
Timeframe: Day 1 to Month 12 (12 months postdelivery)
Number of Infant Participants with MAAEs
Timeframe: Day 1 (birth) to Month 12
Number of Infant Participants with AESIs
Timeframe: Day 1 (birth) to Month 12
Number of Infant Participants with SAEs
Timeframe: Day 1 (birth) to Month 12
Number of Infant Participants With Birth Outcomes
Timeframe: Day 1 (birth) to Month 12