NCT07235397

Evaluating the Benefits of RSV Maternal Vaccination Using a Scottish National Dataset

Evaluating the Benefits Of RSV MaternaL vAccination Using a Scottish National Dataset.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 0 Years – 12 Months
• Healthy volunteers: Not accepted

Summary

This study will use a retrospective cohort design and will be conducted within routinely collected national healthcare and statutory demographic datasets held by PHS and National Records of Scotland (NRS). As such, there will be no active enrollment of study participants, no direct contact with study participants, no collection of any primary data outside of the standard of care (SOC), and no requirement for informed consent. This study design was chosen due to several advantages, over other possible designs, including the ability to evaluate incidence of study outcomes in exposed and unexposed infants, ability to follow infants longitudinally to evaluate study outcomes through 12 months of age, and ability to evaluate all-cause outcomes. Study endpoints, including RSV-associated LRTD hospitalization and RSV-associated hospitalization, among infants born to ABRYSVO-vaccinated mothers (exposed group) will be compared with those among infants born to ABRYSVO-unvaccinated mothers (comparison group) initially from birth through 6 months of age, with later analysis from birth through 12 months as the infants reach this age threshold and their data become available.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	ABRYSVO	ABRYSVO

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2025-11-19
• Last updated: 2026-01-27

Regulatory

• FDA-regulated drug study