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New study tests best way to protect babies from RSV

NCT ID NCT06551506

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at two new ways to prevent RSV, a serious lung infection in babies: a vaccine given to pregnant women and an antibody shot given to infants. Researchers wanted to see how well each method works alone or together. 181 mother-infant pairs took part, and the study measured immune protection over the first year of life.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

181 people

The number who actually took part.

Started

Sep 2024

Finished

May 2026

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. 18-45 years of age at time of enrollment with an uncomplicated singleton pregnancy who are at no known increased risk for complications per clinical judgement of the investigator 2. Understands and agrees to comply with all study procedures 3. Willing and able to provide consent for study participation for themselves and their infant prior to initiation of any study procedures 4. In good health, as determined by the medical history and clinical judgment of the investigator Note: Healthy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. 5. Intention to deliver at a hospital or birthing facility where study procedures can be performed 6. Eligible to receive either product per the FDA package inserts. (Maternal RSVpreF from 32 0/7 to 36 6/7 weeks gestational age (GA) from September 1 to March 31) Exclusion Criteria: 1. Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study 2. Any condition which, in the opinion of the investigators, may pose a health risk for the participant or interfere with the evaluation of study objectives 3. Maternal bleeding diathesis, or any condition which may contraindicate intramuscular injection 4. Maternal known or suspected congenital or acquired disease that impairs the immune system, including functional asplenia or immunosuppression due to underlying illness or treatment 5. Maternal receipt of immunosuppressive drugs or biologic agents within 30 days prior to enrollment (This includes oral or parenteral corticosteroids. The use of inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eye, ears) steroids are permitted. This does not include RhoGAM) 6. Maternal conditions known to impair transplacental transfer of maternal antibodies (e.g., placental pathology, hypergammaglobulinemia, HIV) 7. Maternal history of GBS or other potentially immune-mediated medical condition (PIMMC) 8. Maternal history of severe adverse reaction or anaphylaxis to ABRYSVO or its components 9. Maternal history of preterm birth (\<34 weeks GA) 10. Current pregnancy complicated by uncontrolled hypertension, pre-eclampsia, or eclampsia 11. Previous receipt of ABRYSVO or other approved or investigational RSV vaccine

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030-3411, United States

  • Cincinnati Children's Hospital Medical Center Vaccine Research Center

    Cincinnati, Ohio, 45229-3039, United States

  • Emory University School of Medicine

    Atlanta, Georgia, 30322-1014, United States

  • New York University School of Medicine - Langone Medical Center - Vaccine Center

    New York, New York, 10016-6402, United States

  • University of Maryland, School of Medicine, Center for Vaccine Development and Global Health

    Baltimore, Maryland, 21201-1509, United States

  • University of Pittsburgh - Medicine - Infectious Diseases

    Pittsburgh, Pennsylvania, 15213-3108, United States

  • University of Rochester Medical Center - Vaccine Research Unit

    Rochester, New York, 14611-3201, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212, United States

More trials for these conditions

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