RSV shot for moms: does it shield newborns?

NCT ID NCT07122661

Prevention Sponsor: Pfizer Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study checks how well the RSV vaccine (ABRYSVO) works when given to pregnant women to protect their babies from severe RSV illness. Researchers will look at health records of infants hospitalized with breathing problems in Australia. They want to see if vaccinated moms' babies are less likely to end up in the hospital with RSV.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: ABRYSVO (RSVpreF vaccine)
What this could lead to: If successful, this study could confirm that vaccinating pregnant women helps prevent serious RSV lung infections in newborns.
What could go wrong: This is an observational study, not a controlled trial, so results may be less certain. It only looks at data from one country and may not apply everywhere.

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.

Started

Aug 2025

Expected to finish

Apr 2027

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 hospital-based retrospective study will be conducted in up to 9 hospitals across 6 states/territories in Australia, supported by the Paediatric Active Enhanced Diseases Surveillance Network. Given the retrospective nature of this study, hospitals that already function as national sentinel units for respiratory virus surveillance, or have robust clinical, laboratory or epidemiological surveillance will be included. Each participating hospital conducts year-round standard of care testing for acute respiratory illness which includes respiratory virus panel test using PCR. Study will include all infants through 12 months of age who were admitted to one of the participating hospitals with symptoms of respiratory infection, met the clinical case definition of acute respiratory illness, and had a respiratory specimen collected within 10 days prior to hospital admission through 3 days after a hospital admission with an RSV test result through standard of care testing.

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.

Inclusion Criteria: Participants must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Infant ≤12 months (≤360 days) of age on the hospitalisation date. 2. Index date within the time period for data collection (approximately 01 March 2025 - 28 February 2027) 3. Hospitalised with acute respiratory illness meeting the protocol-defined clinical case definition, and for whom RSV testing results from a specimen collected 10 days prior to hospital admission through 3 days after a hospital admission are known. 4. Infant born to a birth mother eligible to receive ABRYSVO vaccination, with infant date of birth on or after 17 February 2025. Exclusion Criteria: Participants meeting any of the following criteria will not be included in the study: 1. Infant born at \<28 weeks and 0/7 days of gestational age. 2. Infant received any licensed or investigational RSV preventive product (e.g., palivizumab, nirsevimab, active RSV vaccine) since birth. 3. Infant received ≥1 blood transfusion or other blood products containing antibody (e.g., fresh frozen plasma) since birth. 4. Infant born to a birth mother who received any other licensed or investigational RSV vaccine during this pregnancy. 5. Infant born to a birth mother for whom ABRYSVO vaccination status cannot be confirmed in available data sources.

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Conditions

The condition(s) this trial relates to.

lower respiratory tract disorder respiratory system disorder respiratory syncytial virus infectious disease prevention target

As listed by the trial registrant

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

Acute respiratory illness (ARI) Lower respiratory tract disease Respiratory syncytial virus Respiratory syncytial virus (RSV) Respiratory tract diseases

RSV shot for moms: does it shield newborns?

What the study statuses mean