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Pregnancy vaccine shields babies from RSV? new study investigates

NCT ID NCT06813872

Vaccine Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study looks at how well the ABRYSVO vaccine, given to pregnant women, protects their babies from RSV, a leading cause of severe lung infections in infants. Researchers will analyze medical records of infants up to 6 months old in western Pennsylvania over several RSV seasons. No new participants are enrolled; the study uses existing data to measure vaccine effectiveness.

What this could mean

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

Active substance
ABRYSVO (RSV vaccine given during pregnancy)
What this could lead to
If successful, this could confirm that vaccinating pregnant women with ABRYSVO effectively prevents severe RSV in newborns, supporting wider vaccine use.
What could go wrong
This is a small, observational study in one region, so results may not apply everywhere. Real-world effectiveness can vary, and the study does not test new treatments.

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

1 person

The number who actually took part.

Started

Feb 2025

Expected to finish

Jul 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

The study population will include infants who were hospitalized with ARI, have documented RSV test results and born to an individual eligible for ABRYSVO vaccination in pregnancy based on the timing of birth relative to the local seasonal ABRYSVO vaccination program.

Ages

0 to 6 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.

Population included in ABYRSVO VE analyses: 1. Infants ≤ 6 months (≤ 180 days) of age on the index date. 2. Index date within the time period for data collection (approximately 01 October to 15 April in the 2023-2024, 2024-2025, 2025-2026, and 2026-2027 RSV seasons). 3. Infants born at ≥32 weeks of gestation. 4. Infants born to individuals who were expected (based on estimated date of delivery) to reach the indicated ABRYSVO vaccination window (320/7 to 366/7 weeks' gestation) during the local vaccination season. 5. Infant's EHR links to the maternal EHR. 6. Hospitalized at a UPMC facility during the RSV season (according to local hospital epidemiology) with acute respiratory tract illness symptoms meeting the protocol-defined clinical case, and for whom RSV testing results from a specimen collected 10 days prior to hospital admission through 3 days after hospital admission are known. 7. Ability to document maternal ABRYSVO receipt or not. Population excluded from ABYRSVO VE analyses: 1. Infants who received any licensed or investigational RSV preventive product (e.g., RSV monoclonal antibodies, RSV vaccine (including investigational products or due to medication error)) since birth. 2. Born to birth parent for whom ABRYSVO vaccination status cannot be verified in the maternal EHR or Pennsylvania Immunization Electronic Registry System (PIERS) system. 3. Infants who were born to an individual vaccinated with ABRYSVO prior to the current pregnancy or vaccinated with more than one dose of ABRYSVO or vaccinated with any other licensed or investigational RSV vaccine during pregnancy.

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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 viruses

Contacts and locations

Locations

  • Pfizer

    New York, New York, 10001, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.