Effectiveness of ABRYSVO® Maternal Respiratory Syncytial Virus (RSV) Vaccine Against RSV in Infants in Western Pennsylvania

Active, not recruiting

• Conditions: Respiratory Syncytial Viruses
• Interventions: Biological: ABRYSVO Vaccination

• Registration Number: NCT06813872
• Lead Sponsor: Pfizer

Brief Summary

Globally, respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract disease (LRTD) in infants. 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 32 0/7 to 36 6/7 weeks' gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age. 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 Beyfortus (monoclonal antibody (MAB) administered to babies up to 24 months for protection against RSV).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-01-31
• Study First Posted: 2025-02-07
• Study Start: 2025-02-24
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-02
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	ABRYSVO Vaccination	Cases for the primary objective will be infants meeting the outcome definition who had any positive laboratory-confirmed RSV test from a respiratory sample collected within 10 days prior to hospital admission through 3 days after hospital admission.
Control	ABRYSVO Vaccination	Controls for the primary objective will be infants meeting the outcome definition who had a laboratory-confirmed negative RSV test from a respiratory sample collected within 10 days prior to hospital admission through 3 days after hospital admission.

Primary Outcome Measures

Name	Time	Method
ARI hospitalization confirmed by ≥1 acute respiratory illness symptom, laboratory testing and hospitalization occurring 0 to ≤ 90 days of life during the RSV season based on local epidemiology.	0 to ≤ 90 days of life

Secondary Outcome Measures

Name	Time	Method
ARI hospitalization confirmed by ≥ 1 acute respiratory illness symptom, laboratory testing, and hospitalization occurring 0 to ≤180 days of life during the RSV season based on local epidemiology.	0 to ≤180 days of life
ARI hospitalization confirmed by ≥ 1 acute respiratory illness symptom, laboratory testing, and hospitalization occurring 90 to ≤180 days of life during the RSV season based on local epidemiology.	90 to ≤180 days of life
ARI hospitalization with study-defined LRTD occurring 0 to ≤90 days of life during the RSV season based on local epidemiology.	0 to ≤90 days of life
Hospitalization with study-defined LRTD occurring 0 to ≤180 days of life during the RSV season based on local epidemiology.	0 to ≤180 days of life
ARI hospitalization with study-defined LRTD occurring 90 to ≤ 180 days of life during RSV season based on local epidemiology.	90 to ≤ 180 days of life
Number, age and characteristics of infants whose birth parent received ABRYSVO during pregnancy who present for a medical visit and have laboratory-confirmed RSV between 0 to ≤90 days of life during the RSV season based on local epidemiology.	0 to ≤90 days of life
Number, age and characteristics of infants who received Beyfortus between 0 to <7 days of life who present for a medical visit and have laboratory-confirmed RSV btw 1 to ≤90 days post-Beyfortus exposure during the RSV season based on local epidemiology.	1 to ≤90 days post-Beyfortus exposure

Trial Locations

Locations (1)

Pfizer; 🇺🇸 New York, New York, United States