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临床试验/NCT01654224
NCT01654224已完成4 期

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

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
205
试验地点
2
主要终点
Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings

时间窗: 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.

次要结局

  • Non-inferiority and Immunoprotection Persistence at 6 Months(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Nace

Associate Professor of Medicine

University of Pittsburgh

研究点 (2)

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