This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants.
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Percentage of Infant Participants With Medically Attended Lower Respiratory Tract Illness (MA-LRTI) Cases Due to RSV Occurring Within 90 Days After Birth (Efficacy)
Timeframe: Within 90 days after birth
Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 120 Days After Birth (Efficacy)
Timeframe: Within 120 days after birth
Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 150 Days After Birth (Efficacy)
Timeframe: Within 150 days after birth
Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 180 Days After Birth (Efficacy)
Timeframe: Within 180 days after birth
Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 90 Days After Birth (Efficacy)
Timeframe: Within 90 days after birth
Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 120 Days After Birth (Efficacy)
Timeframe: Within 120 days after birth
Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 150 Days After Birth (Efficacy)
Timeframe: Within 150 days after birth
Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 180 Days After Birth (Efficacy)
Timeframe: Within 180 days after birth
Percentage of Infant Participants With Adverse Events of Special Interest (AESI) (Safety)
Timeframe: From birth to 24 months of age
Percentage of Infant Participants With Neonatal Deaths (Safety)
Timeframe: Within 1 Month after birth
Percentage of Infant Participants With Congenital Malformations/Anomalies (Safety)
Timeframe: At birth
Percentage of Infant Participants With Other Neonatal Events (Safety)
Timeframe: Within 1 Month after birth
Number of Infant Participants According to Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute After Birth (Safety)
Timeframe: 1 minute after birth
Number of Infant Participants According to APGAR Score at 5 Minutes After Birth (Safety)
Timeframe: 5 minutes after birth
Number of Infant Participants According to APGAR Score at 10 Minutes After Birth (Safety)
Timeframe: 10 minutes after birth
Percentage of Infant Participants With Adverse Events (AEs) From Birth to 1 Month of Age (Safety)
Timeframe: From birth to 1 month of age
Percentage of Infant Participants With Serious Adverse Events (SAEs) and Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Birth Through 6 Months of Age (Safety)
Timeframe: From birth to 6 months of age
Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 12 Months of Age (Safety)
Timeframe: From birth to 12 months of age
Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 24 Months of Age (Safety)
Timeframe: From birth to 24 months of age
Percentage of Maternal Participants With Prespecified Local Reactions Within 7 Days After Vaccination (Safety)
Timeframe: From Day 1 to Day 7 after vaccination
Percentage of Maternal Participants With Prespecified Systemic Events Within 7 Days After Vaccination (Safety)
Timeframe: From Day 1 to Day 7 after vaccination
Percentage of Maternal Participants With AEs From the Time of Vaccination Through 1 Month After Vaccination (Safety)
Timeframe: From vaccination on Day 1 up to 1 month after vaccination
Percentage of Maternal Participants With SAEs Throughout the Study Period (Safety)
Timeframe: From vaccination on Day 1 up to 6 months after delivery (maximum up to 10 months)