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Impact and Effectiveness of ABRYSVO® Vaccination During Pregnancy

Study acronym: BERNI
StatusActive, Not Recruiting
PhaseNot specified
SponsorPfizer
Started
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Record status
This record was last updated May 15, 2026 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Study completion date: Oct 1, 2026 to Oct 15, 2026v11
  2. 6 versions Re-verified since May 23, 2025, no change to tracked fieldsv5-v10
  3. Eligibility criteria expanded, about 91 words
    • Study description expanded, about 48 words
    v4
  4. 2 versions Re-verified since Feb 5, 2025, no change to tracked fieldsv2-v3
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pfizer
436 trials monitored
See 32 trials at risk
This study will be conducted in collaboration with a research network of independent hospital sites to evaluate the vaccine effectiveness (VE) and impact of ABRYSVO vaccination during pregnancy in a real-world population over multiple seasons, which began in 2024 across Argentina and beginning in 2025 in Uruguay. We will use three retrospective design approaches in this study: (i) a test negative design (TND) to evaluate real-world VE of maternal ABRYSVO against RSV-associated outcomes in infants; (ii) a descriptive cohort design to evaluate the clinical evolution of infants hospitalized with RSV-positive lower respiratory tract disease (LRTD); and (iii) an ecologic before-and-after design to evaluate the impact of ABRYSVO vaccination during pregnancy on infant RSV-associated and all-cause respiratory outcomes.
Trial Details
NCT Number NCT06647654
Lead Sponsor Pfizer
Collaborators: iTrials S.A.
Conditions
(from sponsor)		 Respiratory Syncytial Virus, Respiratory Tract Diseases
Related terms Respiratory Tract Diseases
Enrollment 1 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov