Determinants of Vaccine Response to Influenza Vaccination Among Individuals Over 65 Years of Age - a Population-based Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- Serological evidence of vaccine response to influenza vaccination
研究概览
简要总结
The aims of the study are to a) identify individuals with a poor response to influenza vaccination and b) identify factors associated with a poor response to influenza vaccination.
详细描述
This is a population-based prospective cohort study. Potential participants, males and females between 65 and 80 years of age, were selected randomly through the resident registration office in Hannover city, Germany and invited with a personalized letter to participate in the study.
Initially, a blood sample (40 ml) will be drawn from each participant (day 0). Furthermore, participants will be vaccinated against influenza with FLUAD 2014/2015. FLUAD is a trivalent, surface antigen, inactivated influenza virus vaccine adjuvanted with MF59C.1. Additional five blood samples will be collected during the study period of four months (at days 3, 7, 21, 70 and 130). Information about current and past infections, chronic diseases and basic sociodemographic data will be collected through a self-administered questionnaire.
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
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals between 65 and 80 years of age
排除标准
- •Individuals with a known hypersensitivity to any of the excipients and to eggs, chicken Protein, kanamycin and neomycin sulphate, formaldehyde, and cetyltrimethylammonium bromide
- •Individuals, who have an acute infection during the visit at the study Center
- •Individuals with cognitive impairment
- •Individuals already vaccinated with influenza vaccination in the influenza season 2014/15
结局指标
主要结局
Serological evidence of vaccine response to influenza vaccination
时间窗: 4 months
次要结局
未报告次要终点