Study identification

EU PAS number

EUPAS1000000706

Study ID

1000000706

Official title and acronym

Evaluating the benefits of RSV maternal vaccination using a Scottish National Dataset. (BORLAND)

DARWIN EU® study

No

Study countries

United Kingdom

Study description

This study will use a retrospective cohort design and will be conducted within routinely collected national healthcare and statutory demographic datasets held by Public Health Scotland (PHS) and National Records of Scotland (NRS). As such, there will be no active enrolment 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.
Study outcomes 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.

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 01 September 2024 – 28 February 2026 (or end of respiratory syncytial virus (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 Medical and Healthcare Products Regulatory Agency (MHRA). All infants will be followed for 12 months after birth; thus, the last outcome assessment will be approximately 28 February 2027.

Study status

Planned
Research institutions and networks

Institutions

University of Glasgow

Contact details

Louisa Pollock

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc.
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable