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临床试验/NCT02401893
NCT02401893已完成不适用

Factors Associated With Maintenance of Antibody Responses to Influenza Vaccine in Older, Community-Dwelling Adults

Vanderbilt University0 个研究点目标入组 510 人开始时间: 2009年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
510
主要终点
Maintenance of Immune Response using Hemagglutinin inhibition titers

研究概览

简要总结

Little is known about factors associated with maintenance of hemagglutinin inhibition (HAI) antibodies after influenza vaccination in older adults so the investigators enrolled adults ≥50 years.

详细描述

In the United States, yearly influenza vaccination begins in August or September. However, influenza season can extend into April of the following year. The duration of protection from annual vaccination in older adults is unknown, and little is known about factors associated with the maintenance of response throughout the influenza season. This study evaluated factors associated with the immune response of older adults to trivalent influenza vaccine and the maintenance of antibody responses for the duration of the influenza season.

Subjects

Subjects were enrolled at two sites, Vanderbilt University Medical Center (Nashville, TN) and Marshfield Clinic Research Foundation (Marshfield, WI), during September and October 2009. Subjects were eligible for recruitment if they were ≥50 years of age and had no contraindication to influenza vaccination. Subject recruitment included advertisements at Vanderbilt University Medical Center and letters of invitation to older adults who had received an influenza vaccine in the year prior at Marshfield Clinic.1 All subjects were vaccinated either by their usual caregiver or by the study staff. Strain components for the 2009-2010 Northern Hemisphere vaccine included A/Brisbane/59/2007-like (H1N1), A/Brisbane/10/2007-like (H3N2), and B/Brisbane/60/2008-like. Participants were given the trivalent seasonal vaccine because the 2009 H1N1 pandemic vaccine was not available.

Data Collection

All subjects donated serum pre-vaccination (S1) during September through October 2009, 21 - 28 days post-vaccination (S2) and post-influenza season, May through July, 2010, approximately 250 days (8 months) post-vaccination (S3). Study procedures, informed consent documents and data collection forms were reviewed and approved by Institutional Review Boards at each of the study sites.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •Age >=50 years

排除标准

  • •Prior vaccine allergy or history of guillain barre

结局指标

主要结局

Maintenance of Immune Response using Hemagglutinin inhibition titers

时间窗: 1 year

次要结局

未报告次要终点

研究者

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

Keipp Talbot

Assistant Professor

Vanderbilt University

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