Impact and Effectiveness of ABRYSVO® Vaccination During Pregnancy (NCT06647654) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Impact and Effectiveness of ABRYSVO® Vaccination During Pregnancy
Argentina1 participantsStarted 2024-08-26
Plain-language summary
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.
Who can participate
Age range
0 Years – 24 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Infants ≤9 months (≤270 days) of age on the index date.
. Index date within the time period for data collection (approximately 01 April to 30 September in 2024, 2025, or 2026).
. Infants born at 32 weeks of gestational age or greater.
. Hospitalized for at least 24 hours with LRTD (symptoms related to LRTD might be absent at the time of admission but if they develop within the first 24 hours of hospitalization, the criteria for LTRD will be considered met), and specimen collected for RSV within 10 days prior to hospital admission through 3 days after a hospital admission through SOC testing.
. Infant date of birth 14 days or more after start of the first seasonal ABRYSVO vaccination campaign, to ensure potential to have been born to an ABRYSVO-vaccinated individual.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Infant born to individuals who were expected (based on estimated date of delivery) to reach the indicated ABRYSVO vaccination window (320/7 to 366/7 weeks' gestation) during a local ABRYSVO vaccination season.
Exclusion criteria
. Received any licensed or investigational RSV preventive product (e.g., Palivizumab, Nirsevimab, active RSV vaccine) since birth.
. Received ≥1 blood transfusion or other blood products containing antibody (e.g., fresh frozen plasma) since birth.
. Born to individual who received any other licensed or investigational RSV vaccine during pregnancy.
. Born to individual for whom ABRYSVO vaccination status cannot be confirmed in available data sources.
. Infants with LRTD that require hospitalization for reasons other than clinical criteria (e.g., for social reasons, other medical condition in an infant with LRTD without hospitalization criteria).
. Infants and children ≤24 months of age on the index date.
. Index date during the calendar years for data collection (pre- or post-ABRYSVO program implementation.
. Meets ≥1 outcome definition during the time period for data collection.