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Can a pregnancy vaccine shield newborns from RSV? new study investigates

NCT ID NCT07249320

Vaccine Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 examines how well the ABRYSVO vaccine works when given during pregnancy to prevent RSV in infants. Researchers will compare health outcomes of babies born to vaccinated mothers versus unvaccinated mothers using electronic medical records. The goal is to see if the vaccine reduces RSV-related hospitalizations and other illnesses in the first months of life.

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)
What this could lead to
If successful, this study could confirm that vaccinating pregnant people with ABRYSVO effectively protects their babies from severe RSV disease in the first months of life.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. It only includes data from one healthcare system, which may not apply to everyone.

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

Dec 2025

Expected to finish

Sep 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 comprise eligible maternal-infant pairs over a 2-year study period, identified from EMR records in the existing databases, which accrue in real-time as pregnancies/births occur. All pregnancies that reach 32 0/7 weeks' gestation during the 2-year study period, from September 22, 2023 (start of ABRYSVO vaccination season 1) to January 31, 2025 (estimated end of ABRYSVO vaccination season 2) will be eligible for inclusion, along with all live born infants from the eligible pregnancies. The KPNC pregnancy database will be used to identify the maternal-infant study population. This database links records of newborn infants with their mother, enabling integration of maternal data from across pregnancy and delivery encounters, along with infant birth information and longitudinal follow-up for infants who remain enrolled with KPNC. Infant healthcare encounters after the birth and throughout the follow-up period will be identified in the EMR.

Ages

0 to 50 years

Sex

Anyone

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 Pregnant Individuals - Inclusion Criteria: Participants must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Gestational age at delivery ≥32 0/7 weeks of gestation (earliest gestational age eligible for ABRYSVO vaccination) during the study period 2. Maternal age \>/= 18 to 50 years at pregnancy onset 3. At least 1 prenatal visit between pregnancy onset and 20 weeks of gestation 4. Continuous KPNC enrollment for a minimum of 30 days prior to pregnancy onset through to the date of delivery, with no more than a 2-month administrative gap in coverage Infants - Inclusion Criteria: Participants must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Born to a pregnant individual who has met all inclusion and exclusion criteria outlined above 2. Live birth 3. Enrolled as member in KPNC by 4 months of age (membership indicated in any of months 2-4 of life) Exclusion Criteria Pregnant Individuals - Exclusion Criteria: Participants meeting any of the following criteria will not be included in the study: 1. Received any licensed or investigational RSV vaccine other than ABRYSVO at any time during pregnancy 2. Received ABRYSVO at ≥37 weeks' gestation 3. Received ABRYSVO at \<32 0/7 weeks' gestation Infants - Exclusion Criteria: There are no exclusion criteria for infants. Those who receive any licensed or investigational RSV preventative product (e.g., monoclonal antibodies) at/after birth or any licensed or investigational RSV therapeutic (e.g., antiviral medications) will not be excluded, but their follow-up time will be censored on the date of receipt of the RSV preventative or therapeutic product.

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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 (RSV)

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.