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Effectiveness of ABRYSVO® Maternal Respiratory Syncytial Virus (RSV) Vaccine Against RSV in Infants in Western Pennsylvania
NCT06813872 · View on ClinicalTrials.gov ↗
Study Summary
Globally, respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract disease (LRTD) in infants and children. Pfizer has developed ABRYSVO-a bivalent RSV prefusion F protein-based vaccine (RSVpreF) composed of two prefusion F proteins to protect against both RSV-A and RSV-B. In the United States, ABRYSVO has been approved and recommended for active immunization of pregnant individuals from 320/7 to 366/7 weeks' gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age. Post-licensure data from the United States and Argentina have also demonstrated real world effectiveness. Data from the US VISION and NVSN networks reported 79% (95% CI 55-90) and 70% (95% CI 28-88%) VE respectively against RSV-associated hospitalization among infants in the second RSV season and a study from Argentina reported 78.6% (95% CI 62.1-87.9) and 71.3% (95% CI 53.3-82.3) VE against RSV-associated LRTD leading to hospitalization among infants aged 0 to ≤3 and 0 to ≤6 months respectively. To generate critical evidence to support vaccine policy and implementation, Pfizer will collaborate with University of Pittsburgh to study vaccine effectiveness (VE) of ABRYSVO vaccination during pregnancy against RSV-associated outcomes in infants. The study will take place in a real-world population in Western Pennsylvania over multiple seasons, beginning in the 2023-2024 season, and will use a test negative design (TND) approach. There will be no active enrollment of study participants, no direct contact with study participants, and no collection of any primary data outside of the Standard of Care (SOC). This study will use a TND to evaluate real-world VE of maternal ABRYSVO against RSV-associated outcomes in infants. Additionally, we will describe RSV-associated medically-attended visits for infants exposed to ABRYSVO and RSV monoclonal antibodies (e.g., Beyfortus and Enflonsia).
Conditions Studied
Interventions
- BIOLOGICAL ABRYSVO Vaccination
Study Locations (1)
New York
- Pfizer — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2025-02-24 |
| Est. Completion | 2027-07-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06813872
The ClinicalTrials.gov registry entry for NCT06813872 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Respiratory Syncytial Viruses appearing as the primary indexed condition, and to 1 intervention — of which ABRYSVO Vaccination is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06813872 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06813872 about?
NCT06813872 is a clinical study titled "Effectiveness of ABRYSVO® Maternal Respiratory Syncytial Virus (RSV) Vaccine Against RSV in Infants in Western Pennsylvania". Globally, respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract disease (LRTD) in infants and children. Pfizer has developed ABRYSVO-a bivalent RSV prefusion F protein-based vaccine (RSVpreF) composed of two prefusion F proteins to protect against both RSV-A and RSV-B. In...
What is the current status of trial NCT06813872?
This trial is currently active not recruiting. The enrollment target is 1 participants. The study started on 2025-02-24. Estimated completion is 2027-07-31.
What conditions does trial NCT06813872 study?
This clinical trial studies the following conditions: Respiratory Syncytial Viruses. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06813872?
The interventions under investigation include: ABRYSVO Vaccination (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06813872?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06813872 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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