Adjuvanted Influenza Vaccination in U.S. Nursing Homes
Study Details
Study Description
Brief Summary
This study is powered to prospectively evaluate the relative effectiveness of adjuvanted trivalent influenza vaccine (aTIV; FLUAD) in preventing influenza mortality, hospitalization, and functional decline in a nursing home population in the U.S., compared to the commercially available, standard dose trivalent seasonal influenza vaccine (TIV; Fluvirin).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
SUMMARY: A random study sample of up to 1000 NHs within 75 miles of the local area of the 121 cities where the CDC performs weekly influenza surveillance (estimated N= 11,239) may be offered the opportunity for participation; the first 1000 eligible to participate and accepting the offer will be enrolled. Participating facilities will be offered vaccine education for residents and staff, but will be randomly allocated to receive aTIV (FLUAD) vaccine or usual care (TIV) vaccination for their residents.
BACKGROUND: Lower respiratory tract infection (LRI), including pneumonia, bronchitis, and tracheobronchitis, is the leading cause of infectious mortality and hospitalization in older adults , and nursing home (NH) residents. Pneumonia and infection often produce attenuated signs and symptoms in older adults, leading to delayed or even misdiagnosis for this population. Diagnosis is further compromised due to few and sporadic clinician visits with nursing home residents, and reduced access to radiology. LRI may or may not directly lead to hospitalization, but LRIs are associated with considerable other morbidity than can result in hospitalization, including exacerbation of underlying cardiopulmonary diseases. Hospitalization rates for NH residents vary considerably between facilities, but the majority of hospitalizations occur during the 12 weeks during which influenza peaks each year.
OBJECTIVES: The primary objective is to estimate the differences in hospitalization rates during influenza season experienced by long-stay nursing home residents, between facilities using adjuvanted trivalent vaccine vs. standard trivalent vaccine. The secondary objective is to estimate the differences in the likelihood of Activities of Daily Living (ADL) functional decline and mortality rates in the study nursing homes, and influenza outbreaks.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: aTIV NH facilities randomized to receive adjuvanted trivalent influenza vaccine (aTIV, FLUAD) for the residents |
Biological: adjuvanted trivalent influenza vaccine
Nursing home residents over 65 years are allocated to receive adjuvanted trivalent vaccine. Residents under 65 years are provided standard trivalent vaccine (TIV-Fluvirin).
Other Names:
Biological: trivalent influenza vaccine
Nursing home residents are allocated to receive standard trivalent vaccine (TIV).
Other Names:
|
| Active Comparator: TIV NH facilities randomized to receive standard trivalent influenza vaccine (TIV, Fluvirin) for the residents |
Biological: trivalent influenza vaccine
Nursing home residents are allocated to receive standard trivalent vaccine (TIV).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Hospitalization for a respiratory-related Illness [up to 1 year]
Time to first occurrence of hospitalization for a respiratory-related Illness based upon Medicare inpatient hospital claims
- Hospitalization for all causes [up to 1 year]
Time to first occurrence of hospitalization for all-causes
Secondary Outcome Measures
- Activities of daily living (ADL) scores [up to 1 year]
Change in activities of daily living (ADL) scores
- Mortality [up to 1 year]
Difference in mortality rate
Other Outcome Measures
- Influenza outbreaks [up to 1 year]
Difference in occurrence of documented influenza outbreaks
Eligibility Criteria
Criteria
Inclusion Criteria:
- Long-term care facilities within 75 miles of one of the 121 cities that serve as CDC surveillance sites
Exclusion Criteria:
-
Facilities that used high dose influenza vaccine in residents over age 65 in previous influenza season (2015-16)
-
Facilities having fewer than 50 long-stay residents
-
Hospital-based facilities
-
Facilities with more than 20% of the population under age 65
-
Facilities not submitting Minimum Data Set (MDS) data
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Insight Therapeutics, LLC | Norfolk | Virginia | United States | 23510 |
Sponsors and Collaborators
- Insight Therapeutics, LLC
- Case Western Reserve University
- Brown University
- Seqirus
Investigators
- Principal Investigator: Stefan Gravenstein, MD, MPH, Case Western Reserve Univsity
- Principal Investigator: Vincent Mor, PhD, Brown University
- Principal Investigator: H. Edward Davidson, PharmD, MPH, Insight Therapeutics, LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Hayward AC, Harling R, Wetten S, Johnson AM, Munro S, Smedley J, Murad S, Watson JM. Effectiveness of an influenza vaccine programme for care home staff to prevent death, morbidity, and health service use among residents: cluster randomised controlled trial. BMJ. 2006 Dec 16;333(7581):1241. Epub 2006 Dec 1.
- Thompson WW, Shay DK, Weintraub E, Brammer L, Bridges CB, Cox NJ, Fukuda K. Influenza-associated hospitalizations in the United States. JAMA. 2004 Sep 15;292(11):1333-40.
- Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, Fukuda K. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003 Jan 8;289(2):179-86.
- INSI-201603