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Impact and Effectiveness of ABRYSVO® Vaccination During Pregnancy

NCT06647654 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

ABRYSVO

Test Negative Design: This is a non-interventional retrospective study; therefore, ABSYRVO vaccine has already been administered according to the standard of care. ABRYSVO is a bivalent RSV prefusion F protein-based vaccine (RSVpreF) composed of two prefusion F proteins to protect against both RSV-A and RSV-B. Ecologic Before-and-After Design: This is an ecologic before-and-after study using aggregated data; as such, the 'exposure' of interest is time before ABRYSVO program implementation (i.e., five historical pre-ABRYSVO RSV seasons) and time after ABRYSVO implementation (i.e., post-ABRYSVO RSV seasons: 2024-2026).

Sponsors & Collaborators

  • iTrials S.A.

    collaborator UNKNOWN

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
0 Years
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-26
Primary Completion
2026-10-01
Completion
2026-10-15
FDA Drug
Yes

Countries

  • Argentina

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06647654 on ClinicalTrials.gov