Respiratory Syncytial Virus (RSV)
Conditions
Keywords
Lower respiratory tract infections, acute respiratory tract infections, RSV, maternal immunization
Brief 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 and impact of ABRYSVO vaccination during pregnancy against medically-attended (MA) respiratory syncytial virus (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 to ≤180 days of age, with later assessments from birth to ≤360 days of age and to ≤720 days 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 to ≤180 days of age, birth to ≤360 days of age, and/or birth to ≤720 days 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 first 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.
Interventions
BIOLOGICALABRYSVO
Participants will receive Pfizer's ABRYSVO vaccine as part of standard of care. Vaccine is not administered in this study.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 50 Years
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 2-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 4 months of age (membership indicated in any of months 2-4 of life)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Polymerase chain reaction (PCR)-confirmed RSV LRTD occurring ≤180 days after birth (first episode). | ≤180 days after birth | To estimate VE of ABRYSVO vaccination during pregnancy against RSV LRTD among infants from birth to ≤180 days of age. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Key Secondary 1: PCR-confirmed RSV LRTD hospitalization occurring ≤180 days after birth (first episode). | ≤180 days after birth | To estimate VE of ABRYSVO vaccination during pregnancy against RSV LRTD hospitalization among infants from birth to ≤180 days of age. |
| Secondary 1: PCR-confirmed RSV occurring ≤180 days after birth (first episode). | ≤180 days after birth | To estimate VE of ABRYSVO vaccination during pregnancy against RSV among infants from birth to ≤180 days of age. |
| Secondary 2: PCR-confirmed RSV hospitalization occurring ≤180 days after birth (first episode). | ≤180 days after birth | To estimate VE against RSV hospitalization among infants from birth to ≤180 days of age. |
| Secondary 3: LRTD (any cause) occurring ≤180 days after birth (first episode during the RSV season). | ≤180 days after birth | To estimate VE against all-cause LRTD among infants born in-season from birth through the RSV season (to ≤180 days of age). |
| Secondary 4: LRTD hospitalization (any cause) occurring ≤180 days after birth (first episode during the RSV season). | ≤180 days after birth | To estimate VE against all-cause LRTD hospitalization among infants born in-season from birth through the RSV season (to ≤180 days of age). |
| Secondary 5: Acute otitis media occurring ≤180 days after birth (first episode during the RSV season). | ≤180 days after birth | To estimate VE against acute otitis media among infants born in-season from birth through the RSV season (to ≤180 days of age). |
| Secondary 6: New antibiotic prescriptions occurring ≤180 days after birth (first prescription during the RSV season). | ≤180 days after birth | To estimate VE against new antibiotic prescriptions among infants born in-season from birth through the RSV season (to ≤180 days of age). |
| Secondary 7: PCR-confirmed RSV occurring ≤360 days after birth (first episode). | ≤360 days after birth | To estimate VE and interval-specific VE against RSV among infants from birth to ≤360 days of age. |
| Secondary 8: PCR-confirmed RSV hospitalization occurring ≤360 days after birth (first episode). | ≤360 days after birth | To estimate VE and interval-specific VE against RSV hospitalization among infants from birth to ≤360 days of age. |
| Secondary 9: PCR-confirmed RSV LRTD occurring ≤360 days after birth (first episode). | ≤360 days after birth | To estimate VE and interval-specific VE of ABRYSVO vaccination during pregnancy against RSV LRTD among infants from birth to ≤360 days of age. |
| Secondary 10: PCR-confirmed RSV LRTD hospitalization occurring ≤360 days after birth (first episode). | ≤360 days after birth | To estimate VE and interval-specific VE of ABRYSVO vaccination during pregnancy against RSV LRTD hospitalization among infants from birth to ≤360 days of age. |
Countries
United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed