Clinical trial NCT03599739: Adjuvanted Influenza Vaccination Year 2 Follow-On Survey
Official title: Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes: Assessment of Vaccine Selection and Outcomes for the Follow-on Study Year
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Influenza-like Illness
Influenza, Human
Keywords: Influenza
Vaccine
Vaccination
Nursing Home
Respiratory-Related Hospitalizations
Lead sponsor: Insight Therapeutics, LLC
Sponsor class: OTHER
Collaborators: name: Seqirus
name: Brown University
First posted: 2018-07-26
Enrollment: 598
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Long-term care facilities within 75 miles of one of the 121 cities that serve as CDC surveillance sites. These facilities must not have fewer than 50 long-stay residents, facilities that are hospital based, facilities with more than 20% of the population under age 65, and facilities not submitting Minimum Data Set (MDS) data.

Brief summary: The purpose of this study is to determine if different influenza vaccines produce different outcomes in nursing facility residents receiving the required annual influenza vaccination.

Detailed description: This study will enroll facilities who participated in the adjuvanted influenza vaccine study in 2016-2017 to document the vaccine choice for the 2017-2018 influenza season through a survey. Additional facilities will be enrolled that did not participate to answer a survey responding to questions regarding the vaccine choice for the 2017-2018 and 2018-2019 flu season. Both groups will also gather information on vaccination rates for residents and staff, policies and procedures, and influenza outbreaks.

The facility will complete a profile and answer questions regarding influenza vaccination in their facilities for the 2017-2018 and 2018-2019 flu seasons.

The study team will obtain data from the Centers for Medicare \& Medicaid Services in 2019 to determine the study outcomes. None of the data used in the analysis will be linked to individual residents in facilities.

Eligibility criteria: Inclusion Criteria:

* Participated in the Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes study
* OR
* Long-term care facilities within 75 miles of one of the 121 cities that serve as CDC surveillance sites

Exclusion Criteria:

* 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

Primary outcomes:
measure: Hospitalization for all causes
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Insight Therapeutics, LLC
state: Virginia
Study officials:
affiliation: Brown University
name: Stefan Gravenstein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Vincent Mor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Pedro Gozalo, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Insight Therapeutics, LLC
name: H. Edward Davidson, PharmD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: DiazGranados CA, Dunning AJ, Robertson CA, Talbot HK, Landolfi V, Greenberg DP. Effect of Previous-Year Vaccination on the Efficacy, Immunogenicity, and Safety of High-Dose Inactivated Influenza Vaccine in Older Adults. Clin Infect Dis. 2016 May 1;62(9):1092-1099. doi: 10.1093/cid/ciw085. Epub 2016 Feb 21.
citation: Flannery B, Chung JR, Thaker SN, Monto AS, Martin ET, Belongia EA, McLean HQ, Gaglani M, Murthy K, Zimmerman RK, Nowalk MP, Jackson ML, Jackson LA, Foust A, Sessions W, Berman L, Spencer S, Fry AM. Interim Estimates of 2016-17 Seasonal Influenza Vaccine Effectiveness - United States, February 2017. MMWR Morb Mortal Wkly Rep. 2017 Feb 17;66(6):167-171. doi: 10.15585/mmwr.mm6606a3.
citation: Gravenstein S, Davidson HE, Taljaard M, Ogarek J, Gozalo P, Han L, Mor V. Comparative effectiveness of high-dose versus standard-dose influenza vaccination on numbers of US nursing home residents admitted to hospital: a cluster-randomised trial. Lancet Respir Med. 2017 Sep;5(9):738-746. doi: 10.1016/S2213-2600(17)30235-7. Epub 2017 Jul 20.