Phase 4
N=152
Immunogenicity of RSV Vaccines in Residents of Long-Term Care Facilities (LTCF)
Respiratory Syncytial Virus (RSV)
Bottom Line
View on ClinicalTrials.gov: NCT06077149 ↗Enrolled (actual)
152
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Geometric Mean Fold Rise Against RSV Fa Protein — 12.5; 9.9 fold change — p=0.14
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- RSV vaccine (Biological)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Fold Rise Against RSV Fa Protein |
12.5; 9.9 | 0.14 |
| PRIMARY Geometric Mean Fold Rise Against RSV Fb Protein |
11.0; 8.7 | 0.17 |
| PRIMARY Geometric Mean Fold Rise Against RSV A2 Protein |
15.5; 12.8 | 0.32 |
| SECONDARY Ratio of Fold Response of RSV A2 Titer to Fa Titer |
1.15; 1.18 | 0.82 |
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 adults over age 60 years living in the community.
Eligibility Criteria
Inclusion Criteria
- ≥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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT06077149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.