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Scottish data to reveal if RSV shot shields newborns

NCT ID NCT07235397

Knowledge-focused Sponsor: Pfizer Source: ClinicalTrials.gov ↗

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This trial is taking on new participants right now.
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Registered, but not yet taking participants.
By invitation only
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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

Expanded access (not trials)

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Approved
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When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study looks at health records of babies born in Scotland to see if those whose mothers received the RSV vaccine (ABRYSVO) during pregnancy have fewer hospital visits for RSV. No new participants are enrolled; researchers will analyze existing data. The goal is to understand how well the vaccine works in real-world conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1 person

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

0 years to 12 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Infants must meet all inclusion criteria to be eligible for inclusion in the study: 1. Live birth in Scotland from 1st September 2024 to 28th February 2026 2. 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: 1. Born to a mother who received any licensed or investigational RSV vaccine other than ABRYSVO at any time during pregnancy 2. Meets UK national guidelines for monoclonal antibody receipt

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Conditions

The condition(s) this trial relates to.

respiratory syncytial virus infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Respiratory syncytial virus infections

How to take part

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  1. The official record

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