Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting

University of Pittsburgh

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Biological: High Dose Inactivated Influenza Vaccine; Biological: Standard Dose Inactivated Influenza Vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01654224

PRO10110247

Details and patient eligibility

About

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.

Full 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.

Enrollment: 205 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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205 participants in 2 patient groups

High Dose Inactivated Influenza Vaccine

Active Comparator group

Description:

For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin

Treatment:

Biological: High Dose Inactivated Influenza Vaccine

Standard Dose Inactivated Influenza Vaccine

Active Comparator group

Description:

For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin

Treatment:

Biological: Standard Dose Inactivated Influenza Vaccine