Immune Response to High-Dose vs. Standard Dose Influenza Vaccine
试验速览
- 阶段
- 4 期
- 入组人数
- 85
- 试验地点
- 4
- 主要终点
- Number of Influenza Cases
研究概览
简要总结
This 5-year proposal is a randomized study of split-virus influenza vaccine (SVV) in a high-dose (HD) vs. standard-dose (SD) formulation in each of five influenza seasons to define the key determinants of vaccine-mediated protection against influenza and how these immunologic mediators may be enhanced by vaccination with a newly approved high-dose influenza vaccine in older people
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent provided by the participant
- •Age 20-40 years old with no underlying chronic diseases or age ≥65 years old
- •Willing to receive influenza vaccination
- •Older cohort has received their influenza vaccine for the previous influenza season
排除标准
- •Immunosuppressive disorders or medications (including oral prednisone in doses >10 mg daily)
- •Have not received influenza vaccination in the past or cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination
- •Participant has received a community available influenza vaccine for the approaching influenza season
- •Females who are pregnant at Visit 1 (a pregnancy test will be administered for all females of child-bearing potential)
结局指标
主要结局
Number of Influenza Cases
时间窗: five years
Influenza surveillance includes weekly contact with study subjects to assess for any flu-like symptoms or acute respiratory infection (ARI), and include nasopharyngeal swabs (within 5 days of onset of symptoms) for polymerase chain reaction (PCR) detection of influenza virus and post-influenza season detection of an antibody response to influenza infection. Routine screen for symptoms of ARI will also occur at the 4, 10 and 20 week visits when blood samples are collected. Influenza illness will be documented by PCR detection of influenza during an IARI or seroconversion (4-fold rise in antibody titers) in association with an ARI. ARI includes upper (coryza or sore throat) or lower (cough or shortness of breath) respiratory tract symptoms, or headache, malaise, myalgia or fever (\> 99°F or 37.3°C orally or 100°F rectally) \[41\]. as physician visits, hospitalizations and deaths attributed to acute cardiopulmonary illness and will be tracked through the influenza season.
次要结局
未报告次要终点
研究者
Janet McElhaney
Senior Scientist, AMRIC, Professor (NOSM), Medical Lead for Senior's Care and Consulting Geriatrician (HSN), HSN Volunteer Association Chair in Geriatric Research
Health Sciences North Research Institute