New study tests best way to protect babies from RSV
NCT ID NCT06551506
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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181 people
The number who actually took part.
- Started
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Sep 2024
- Finished
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May 2026
- Lead sponsor
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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
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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Baylor College of Medicine
Houston, Texas, 77030-3411, United States
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Cincinnati Children's Hospital Medical Center Vaccine Research Center
Cincinnati, Ohio, 45229-3039, United States
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Emory University School of Medicine
Atlanta, Georgia, 30322-1014, United States
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New York University School of Medicine - Langone Medical Center - Vaccine Center
New York, New York, 10016-6402, United States
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University of Maryland, School of Medicine, Center for Vaccine Development and Global Health
Baltimore, Maryland, 21201-1509, United States
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University of Pittsburgh - Medicine - Infectious Diseases
Pittsburgh, Pennsylvania, 15213-3108, United States
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University of Rochester Medical Center - Vaccine Research Unit
Rochester, New York, 14611-3201, United States
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Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a simple breath test catch flu in High-HIV regions?
- RSV drug trial for kids under 5 halted early – only 4 children enrolled
- Could a shot for moms shield babies from deadly RSV?
- RSV study seeks immune clues in older adults
- New study aims to predict severe bronchiolitis in infants
- New RSV vaccine shows promise for seniors in large trial