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NCT07249320

Evaluating ABRYSVO Maternal Vaccine Effectiveness Among Infants

Active, enrolled Last updated 19 December 2025
What this trial tests

trial testing ABRYSVO in Respiratory Syncytial Virus (RSV) in 39,456 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 December 2025
Primary endpoint
30 September 2027
30 September 2027

Quick facts

Lead sponsorPfizer
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment39,456
Start date1 December 2025
Primary completion30 September 2027
Estimated completion30 September 2027
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Pfizer — full company profile →

Who can join

Adults 0 to 50, any sex, with Respiratory Syncytial Virus (RSV). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 hospitalization. Non-specific all-cause infant outcomes will include: all-cause LRTD, all-cause LRTD hospitalization, acute otitis media, and new antibiotic prescription (for any diagnosis). Identification of these outcomes will be based on ICD-10-CM diagnostic codes documented in infant EMRs during a healthcare encounter in a KPNC healthcare setting, occurring during the relevant follow-up window.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of ABRYSVO

Trials testing the same drug.

Other recruiting trials for Respiratory Syncytial Virus (RSV)

Currently open trials in the same condition.

Other Pfizer trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07249320.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing