Status:
COMPLETED
Immunogenicity of RSV Vaccines in Residents of Long-Term Care Facilities (LTCF)
Lead Sponsor:
University of Rochester
Conditions:
Respiratory Syncytial Virus (RSV)
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
This clinical trial is studying the newly licensed RSV vaccines in adults over age 60 years living in long-term care facilities (nursing homes) by comparing the immune response to their vaccine to adu...
Detailed Description
This was an open label non-inferiority study to evaluate immunogenicity where all participants received either the Pfizer RSV Vaccine (ABRYSVO) or GSK RSV Vaccine (AREXVY) as part of Standard of Care ...
Eligibility Criteria
Inclusion
- ≥60 years of age who live in skilled nursing facilities or reside independently in the community
- Life expectancy of \>6 months, as assessed by the investigator
- Able to sign informed consent or to provide consent via a legally authorized representative (LAR)
Exclusion
- History of a current immunosuppressive condition or receipt of chemotherapy or other immunosuppressive or cytotoxic therapy, including chronic prednisone use of ≥ 20 mg/day for more than 14 days within 3 months of study vaccination
- History of hypersensitivity or reaction to any vaccine component
- Simultaneous administration of another vaccine (influenza, SARS-CoV-2) or within a 14-day window before or after intervention
- Previous receipt or intended receipt of an RSV vaccine outside the study
- Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
- Documented RSV infection within 2 months prior to study intervention.
Key Trial Info
Start Date :
November 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2024
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT06077149
Start Date
November 7 2023
End Date
November 1 2024
Last Update
October 27 2025
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642