Evaluating ABRYSVO Maternal Vaccine Effectiveness Among Infants

N/AActive Not RecruitingNCT07249320

Pfizer39,456 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

39,456

Eligibility

Sex: ALLMin age: 0 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria Pregnant Individuals - Inclusion Criteria: Participants must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Gestational age at delivery ≥32 0/7 weeks of gestation (earliest gestational age eligible for ABRYSVO vaccination) during the study period 2. Maternal age 18 to 50 years at pregnancy onset 3. At least 1 prenatal visit between pregnancy onset and 20 weeks of gestation 4. Continuous KPNC enrollment for a minimum of 30 days prior to pregnancy onset through to the date of delivery, with no more than a 1-month administrative gap in coverage Infants - Inclusion Criteria: Participants must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Born to a pregnant individual who has met all inclusion and exclusion criteria outlined above 2. Live birth 3. Enrolled as member in KPNC by 3 months of age Exclusion Criteria Pregnant Individuals - Exclusion Criteria: Participants meeting any of the following criteria will not be included in the study: 1. Received any licensed or investigational RSV vaccine other than ABRYSVO at any time during pregnancy 2. Received ABRYSVO at ≥37 weeks' gestation 3. Received ABRYSVO at \<32 0/7 weeks' gestation Infants - Exclusion Criteria: There are no exclusion criteria for infants. Those who receive any licensed or investigational RSV preventative product (e.g., monoclonal antibodies) at/after birth or any licensed or investigational RSV therapeutic (e.g., antiviral medications) will not be excluded, but their follow-up time will be censored on the date of receipt of the RSV preventative or therapeutic product.

Outcomes

Primary Outcomes

Polymerase chain reaction (PCR)-confirmed RSV LRTD occurring ≤180 days after birth (first episode).

To estimate VE of ABRYSVO vaccination during pregnancy against RSV LRTD among infants from birth through 6 months of age.