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

Phase 4

Completed

• Conditions: Influenza
• Interventions: Biological: High Dose Inactivated Influenza Vaccine; Biological: Standard Dose Inactivated Influenza Vaccine

• Registration Number: NCT01654224
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-07-27
• Study First Submitted QC: 2012-07-27
• Study First Posted: 2012-07-31
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2016-02-12
• Results First Submitted QC: 2016-06-03
• Results First Posted: 2016-07-14
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose Inactivated Influenza Vaccine	High Dose Inactivated Influenza Vaccine	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
Standard Dose Inactivated Influenza Vaccine	Standard Dose Inactivated Influenza Vaccine	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

Primary Outcome Measures

Name	Time	Method
Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings	Day 0	The primary objective of this study is to determine the noninferiority of high- dose inactivated influenza vaccine (HDIV) versus standard dose inactivated influenza vaccine(SDIV)among residents of long term care(LTC)settings.Non-inferiority will be determined by comparing baseline and one month post vaccination HAI and MN titers using non-inferiority analysis.

Secondary Outcome Measures

Name	Time	Method
Non-inferiority and Immunoprotection Persistence at 6 Months	6 months	Compare the immunogenicity via HAI and MN titers for HDIV and SDIV at 6 months in frail LTC residents

Trial Locations

Locations (1)

University of Pittsburgh, Division of Geriatric Medicine; 🇺🇸 Pittsburgh, Pennsylvania, United States