Phase 4
Completed N=2,957
High Dose Influenza Vaccine in Nursing Home - Pilot Study
Source: ClinicalTrials.gov NCT01720277 ↗Enrolled (actual)
2,957
Serious AEs
—
Results posted
Apr 2018
Primary outcomePrimary: Total All-cause Hospitalizations — 197; 301 events
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this pilot evaluation is to help determine the feasibility and power needed to prospectively evaluate relative effectiveness of high-dose influenza vaccine in preventing influenza mortality and hospitalization in a nursing home population in the U.S., compared to the standard-dose influenza vaccine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total All-cause Hospitalizations |
197; 301 | — |
| SECONDARY Change in Residents' Functional Status |
196; 206 | — |
Eligibility Criteria
Inclusion Criteria
- Long-term care facilities in one of the 122 cities that serve as Center for Disease Control and Prevention (CDC) surveillance sites
Exclusion Criteria
- Facilities already systematically administering HD vaccine to their residents
- Facilities for whom over half the residents are on Medicare (short-stay)
- Facilities in which over half the residents are on Medicare Part A (SNF)
- Facilities having fewer than 50 long-stay residents
- Hospital-based facilities
- Facilities with more than 20% of the population under age 65
- Facilities with mandated (employment-dependent) seasonal influenza vaccination
- Facilities not submitting MDS data
Data sourced from ClinicalTrials.gov (NCT01720277). 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. Informational only — not medical advice.