Adjuvanted Influenza Vaccination in U.S. Nursing Homes

Influenza Clinical Trial

Official title:

Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02882100
• Other study ID #: INSI-201603
• Status: Completed
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: January 25, 2023

Study information

• Verified date: March 2023
• Source: Insight Therapeutics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 823
• Est. completion date: January 25, 2023
• Est. primary completion date: October 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Influenza-like Illness

Intervention

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).
• trivalent influenza vaccine
Nursing home residents are allocated to receive standard trivalent vaccine (TIV).

Locations

Country	Name	City	State
United States	Insight Therapeutics, LLC	Norfolk	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
Insight Therapeutics, LLC	Brown University, Case Western Reserve University, Seqirus

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. doi: 10.1136/bmj.39010.581354.55. Epub 2006 Dec 1. — View Citation

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. doi: 10.1001/jama.292.11.1333. — View Citation

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. doi: 10.1001/jama.289.2.179. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Influenza outbreaks	Difference in occurrence of documented influenza outbreaks	up to 1 year
Primary	Hospitalization for a respiratory-related Illness	Time to first occurrence of hospitalization for a respiratory-related Illness based upon Medicare inpatient hospital claims	up to 1 year
Primary	Hospitalization for all causes	Time to first occurrence of hospitalization for all-causes	up to 1 year
Secondary	Activities of daily living (ADL) scores	Change in activities of daily living (ADL) scores	up to 1 year
Secondary	Mortality	Difference in mortality rate	up to 1 year

External Links

•   FDA approves first seasonal influenza vaccine containing an adjuvant