Respiratory Syncytial Virus InfectionsBORLANDNCT07235397
Evaluating the Benefits of RSV Maternal Vaccination Using a Scottish National Dataset
An observational study of Respiratory Syncytial Virus Infections, run by Pfizer.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 0 years to 12 months
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- ABRYSVO
- Type of treatment
- Vaccines
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years to 12 months
- All sexes
- No healthy volunteers
- Child
Study 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.
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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Benefits Of RSV MaternaL vAccination Using a Scottish National Dataset.
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.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- ABRYSVO
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABRYSVOBiological
ABRYSVO
| Study group | Role | What they receive |
|---|---|---|
| Exposed | Infants whose mother received ABRYSVO vaccine during pregnancy 14 days or more before delivery Receives: Biological: ABRYSVO | |
| Unexposed | Infants born to mothers who did not receive ABRYSVO during pregnancy will be considered unexposed |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR-confirmed RSV-associated LRTD hospitalization occurring ≤180 days after birth (first episode)
Measured: ≤180 days after birth
Secondary outcomes (7)
PCR-confirmed RSV-associated hospitalization occurring ≤180 days after birth (first episode)
Measured: ≤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
Measured: ≤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
Measured: ≤180 days after birth
PCR-confirmed RSV-associated LRTD hospitalization occurring ≤360 days after birth (first episode) (by cumulative and by discrete age-intervals)
Measured: ≤360 days after birth
PCR-confirmed RSV-associated hospitalization occurring ≤360 days after birth (first episode) (by cumulative and by discrete age-intervals)
Measured: ≤360 days after birth
LRTI hospitalization (any cause) occurring ≤360 days after birth (first episode during the RSV season) (cumulative and by age-intervals)
Measured: ≤360 days after birth
ARI hospitalization (any cause) occurring ≤360 days after birth (first episode during the RSV season) (cumulative and by age-intervals)
Measured: ≤360 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start15 Oct 2026 (estimated)
- Primary completion13 Nov 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235397
- Sponsor's protocol ID
- C3671083
- Acronym
- BORLAND
- Status last verified
- Sep 2026
- First submitted
- 14 Nov 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Benefits Of RSV MaternaL vAccination Using a Scottish National Dataset.
- ClinicalTrials.gov ID
- NCT07235397
- Acronym / sponsor ID
- BORLAND / C3671083
- Conditions
- Respiratory Syncytial Virus Infections
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 13 Nov 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | Biological: ABRYSVOInfants whose mother received ABRYSVO vaccine during pregnancy 14 days or more before delivery |
| Unexposed | – | –Infants born to mothers who did not receive ABRYSVO during pregnancy will be considered unexposed |
Who may qualify
- Ages
- 0 years to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABRYSVOABRYSVO | Biological | Exposed |
Primary outcome
PCR-confirmed RSV-associated LRTD hospitalization occurring ≤180 days after birth (first episode)
Time frame: ≤180 days after birth
7 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus Infections, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCR-confirmed RSV-associated LRTD hospitalization occurring ≤180 days after birth (first episode) (time frame: ≤180 days after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.