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

ConditionRespiratory Syncytial Virus Infections

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age0-12

SponsorPfizer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

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

Disqualifiers

None

Trial population

This will be a whole population birth cohort study of all live-born infants born in Scotland during the study period. In Scotland, all infants are assigned a unique identifier, the Community Health Index (CHI) at birth. CHI is a common identifier across all National Health Service (NHS) healthcare encounters and allows linkage of all healthcare data to statutory datasets such as death records. The patient population will include all live-born infants born in Scotland over an 18-month accrual period, from 1st September 2024 - 28th February 2026 (or end of RSV season) and their mothers (approximately 69,000 mother-infant pairs). Selection criteria for the population were based on the time period of the RSV season in Scotland and the earliest gestational age eligible for ABRYSVO vaccination, per the MHRA. All infants will be followed for 12 months after birth; thus, the last outcome assessment will be approximately 28th February 2027.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

ABRYSVO
Biological/Vaccine
ABRYSVO

Treatment groups

1 Participants

are divided into 2 treatment groups

Group A: Exposed1 intervention

Group B: Unexposed0 interventions

Trial outcomes

Primary outcomes

PCR-confirmed RSV-associated LRTD hospitalization occurring ≤180 days after birth (first episode)

Time frame

≤180 days after birth

Secondary outcomes

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

Other outcomes

PCR-confirmed RSV-associated hospitalization stratified by: gestational age (GA) at delivery, GA at vaccination, time from vaccination to birth, with/without administration with other maternal vaccines, breastfeeding status & infant deprivation index

Time frame

≤360 days after birth

Infant & hospitalization characteristics (e.g. infant age at hospitalization, duration of stay in days, level of care, disease severity, death) among infants ≤360 days after birth with RSV-associated hospitalization & maternal ABYRSVO vaccination status

Time frame

≤360 days after birth

Relative risk of breakthrough RSV in infants born to mothers vaccinated with ABRYSVO by sex, gestational age at birth, low birth weight, deprivation index, ethnicity, time between vaccine and delivery, and maternal morbidity status.

Time frame

≤360 days after birth

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: