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NCT06813872 · ClinicalTrials.gov registry record
Effectiveness of ABRYSVO® Maternal Respiratory Syncytial Virus (RSV) Vaccine Against RSV in Infants in Western Pennsylvania
A clinical trial of Respiratory Syncytial Viruses, sponsored by Pfizer.
- Active
- Registry status
- 1
- Enrollment target
- 1
- Study location
NCT06813872: Active study of Respiratory Syncytial Viruses, sponsored by Pfizer.
NCT06813872 is a study of Respiratory Syncytial Viruses that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 1 participants, below the 193-participant average among 3 other Respiratory Syncytial Viruses trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06813872, a study of Respiratory Syncytial Viruses, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- 1 participants
- Enrollment target
- 1
- Study location
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 |
What the registry record for NCT06813872 still lists
NCT06813872 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 193-participant average among 3 other Respiratory Syncytial Viruses trials with a reported enrollment target (99% lower).
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.
NCT06813872 reports a single indexed study location in New York.
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.
What interventions are being tested in trial NCT06813872?
The interventions under investigation include: ABRYSVO Vaccination (BIOLOGICAL).
Who is sponsoring clinical trial NCT06813872?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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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