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Not yet recruiting NCT07235397

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

— Observational Respiratory Syncytial Virus Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ABRYSVO.
Who it may be relevant to
Registry conditions: Respiratory Syncytial Virus Infections. Basic parameters: 0 years — 12 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Biological ABRYSVO
    ABRYSVO

Primary outcome measures

  • PCR-confirmed RSV-associated LRTD hospitalization occurring ≤180 days after birth (first episode) [Time frame: ≤180 days after birth]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

Infants must meet all inclusion criteria to be eligible for inclusion in the study:

  • Live birth in Scotland from 1st September 2024 to 28th February 2026
  • Gestational age at birth ≥28(0/7) weeks of gestation (earliest gestational age eligible for ABRYSVO vaccination)

Infants meeting any of the following criteria will not be included in the study:

  • Born to a mother who received any licensed or investigational RSV vaccine other than ABRYSVO at any time during pregnancy
  • Meets UK national guidelines for monoclonal antibody receipt

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07235397 · C3671083

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗