Clinical trial NCT01654224: Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting
Official title: Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza in Long Term Care Setting
High dose Inactivated influenza vaccine
Standard dose inactivated influenza vaccine
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Sanofi Pasteur, a Sanofi Company
First posted: 2012-07-31
Enrollment: 205
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to compare the performance of two currently available influenza (flu) vaccines. This study will try and determine if the high dose flu vaccine provides protection that is the same or better than that of regular dose flu vaccine. Both the regular dose and the high dose flu vaccines are approved by the FDA for use in older adults.

Detailed description: Influenza and pneumonia are the fifth leading cause of death in the United States, the leading cause of vaccine preventable death, and the leading cause of infection related deaths among nursing home residents(Nace, Drinka et al.2010). Each year, an estimated 36,000 individuals die from seasonal influenza and over 90% of these deaths occur among older adults, primarily the frail older adults residing in LTC settings(Fiore,Uyeki et al. 2010).Vaccination is the most effective means of preventing influenza (Nichol and Treanor 2006). Despite increasing success in immunizing LTC residents though, outbreaks continue to occur annually with case fatality rates ranging between 5-55% (Nace 2008). Older adults have a reduced response to influenza vaccination, in part due to age related immunosenescence (Keitel, Atmar et al. 1121; Skowronski, Tweed et al. 2008). It is widely recognized that more effective vaccine options are needed for frail older adults. One option is to increase the hemagglutinin (HA) dose in influenza vaccines in an effort to increase antibodies to hemagglutinin. To date, no studies have evaluated the effectiveness of the HDIV among LTC residents.

Eligibility criteria: Inclusion Criteria:

* Residents of one of the participating LTC sites
* 65 years or older at the time of consent
* require assistance in two or more Instrumental Activities of Daily Living and/or one or more Activities of Daily Living as identified by facility staff

Exclusion Criteria:

* Age less than 65 years
* Life expectancy less than 6 months
* History of allergic reaction to influenza vaccine, its components, or eggs
* History of severe allergic reaction to latex
* History of Guillian-Barre Syndrome
* Actively undergoing chemotherapy
* Actively undergoing radiation therapy
* Use of prednisone (or other steroid) at prednisone-equivalent dosages of 10mg or higher within the past 14 days
* Serious current immunosuppression or immunosuppression expected in the next 6 weeks
* Any condition that, in the opinion of the investigator,might interfere with the evaluation of study objectives

Primary outcomes:
measure: Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings
timeFrame: 30 days
measure: Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings
timeFrame: Day 0
Secondary outcomes:
measure: Non-inferiority and Immunoprotection Persistence at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Division of Geriatric Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh, Division of Geriatric Medicine
name: David A. Nace, MD, MPH, CMD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nace DA, Lin CJ, Ross TM, Saracco S, Churilla RM, Zimmerman RK. Randomized, controlled trial of high-dose influenza vaccine among frail residents of long-term care facilities. J Infect Dis. 2015 Jun 15;211(12):1915-24. doi: 10.1093/infdis/jiu622. Epub 2014 Dec 17.