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NCT07249320 · ClinicalTrials.gov registry record
Evaluating ABRYSVO Maternal Vaccine Effectiveness Among Infants
A clinical trial of Respiratory Syncytial Virus (RSV), sponsored by Pfizer.
- Active
- Registry status
- 39,456
- Enrollment target
- 1
- Study location
NCT07249320 is a study of Respiratory Syncytial Virus (RSV) that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 39,456 participants, above the 3,169-participant average among 11 other Respiratory Syncytial Virus (RSV) trials with a reported enrollment target (1145% higher). The trial reports 1 study location across 1 state.
The verdict
NCT07249320, a study of Respiratory Syncytial Virus (RSV), is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- 39,456 participants
- Enrollment target
- 1
- Study location
Study Summary
To generate critical evidence to support vaccine policy and implementation, Pfizer will collaborate with Kaiser Permanente Northern California (KPNC) to study the vaccine effectiveness (VE) of ABRYSVO vaccination during pregnancy in a real-world population. The overall research question of this study is: what is the effectiveness of ABRYSVO vaccination during pregnancy against medically-attended (MA) RSV-associated and all-cause infant outcomes in a large, diverse, real-world population? This study will use a retrospective cohort design and will be conducted within an integrated delivery health care organization using electronic medical record (EMR) data collected during routine standard of care clinical encounters. Study outcomes among infants born to ABRYSVO-vaccinated mothers (exposed group) will be compared with those among infants born to ABRYSVO-unvaccinated mothers (comparison group) initially from birth through 6 months of age, with later assessments from birth through 12 months of age and through 24 months of age as the infants reach these age thresholds and their data become available. There are two categories of outcomes of interest in this study: RSV-specific infant outcomes and non-specific all-cause infant outcomes, assessed within several follow-up windows (birth through 6 months of age, birth through 12 months of age, and/or birth through 24 months of age, depending on the outcome). Identification of RSV-specific outcomes will be based on the first positive laboratory-confirmed PCR test from a respiratory specimen during a healthcare encounter in a KPNC healthcare setting, occurring during the relevant follow-up window. RSV-positive test results will be combined with International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnostic codes to define the RSV-specific outcomes. RSV-specific outcomes will include: PCR-confirmed RSV, PCR-confirmed RSV hospitalization, PCR-confirmed RSV LRTD, and PCR-confirmed RSV LRTD
Conditions Studied
Interventions
- BIOLOGICAL ABRYSVO
Study Locations (1)
New York
- Pfizer - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39,456 participants |
| Start Date | 2025-12-01 |
| Est. Completion | 2027-09-30 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07249320
The ClinicalTrials.gov registry entry for NCT07249320 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 39,456 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 3,169-participant average among 11 other Respiratory Syncytial Virus (RSV) trials with a reported enrollment target (1145% higher). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Respiratory Syncytial Virus (RSV) appearing as the primary indexed condition, and to 1 intervention - of which ABRYSVO is the first listed.
NCT07249320 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT07249320 about?
NCT07249320 is a clinical study titled "Evaluating ABRYSVO Maternal Vaccine Effectiveness Among Infants". To generate critical evidence to support vaccine policy and implementation, Pfizer will collaborate with Kaiser Permanente Northern California (KPNC) to study the vaccine effectiveness (VE) of ABRYSVO vaccination during pregnancy in a real-world population. The overall research question of this stud...
What is the current status of trial NCT07249320?
This trial is currently active not recruiting. The enrollment target is 39,456 participants. The study started on 2025-12-01. Estimated completion is 2027-09-30.
What conditions does trial NCT07249320 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus (RSV).
What interventions are being tested in trial NCT07249320?
The interventions under investigation include: ABRYSVO (BIOLOGICAL).
Who is sponsoring clinical trial NCT07249320?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07249320 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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