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.
Study Type
OBSERVATIONAL
Enrollment
1
ABRYSVO
PCR-confirmed RSV-associated LRTD hospitalization occurring ≤180 days after birth (first episode)
Time frame: ≤180 days after birth
PCR-confirmed RSV-associated hospitalization occurring ≤180 days after birth (first episode)
Time frame: ≤180 days after birth
PCR-confirmed RSV-associated LRTD hospitalization occurring ≤180 days after birth (first episode) stratified by term/preterm status and by gestational age at vaccination
Time frame: ≤180 days after birth
PCR-confirmed RSV-associated hospitalization occurring ≤180 days after birth (first episode) stratified by term/preterm status at delivery and by gestational age at vaccination
Time frame: ≤180 days after birth
PCR-confirmed RSV-associated LRTD hospitalization occurring ≤360 days after birth (first episode) (by cumulative and by discrete age-intervals)
Time frame: ≤360 days after birth
PCR-confirmed RSV-associated hospitalization occurring ≤360 days after birth (first episode) (by cumulative and by discrete age-intervals)
Time frame: ≤360 days after birth
LRTI hospitalization (any cause) occurring ≤360 days after birth (first episode during the RSV season) (cumulative and by age-intervals)
Time frame: ≤360 days after birth
ARI hospitalization (any cause) occurring ≤360 days after birth (first episode during the RSV season) (cumulative and by age-intervals)
Time frame: ≤360 days after birth
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