Open-Label, Randomized Study of Immune Response to Licensed Influenza Vaccines in Adults 65-74 Years of Age (US Flu Vaccine Effectiveness Serologic Study, 2016-17 and 2017-18)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- HI Titers, HD vs. AD, Yr 2 Day 28 Post Vaccination
研究概览
简要总结
This is an open-label, randomized trial in up to 210 adults aged 65-74 years to evaluate the immune response to consecutive influenza vaccination across 2 seasons. Participants will be randomized to receive 1 of 3 licensed and recommended vaccines in the first year; 2 arms will receive the same vaccination in the second year and the third arm will be randomized again to 1 of 3 licensed vaccines. All participants will have pre and post-vaccination serum blood draws for a total of 6 draws over 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 74 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65-74 years at the time of study enrollment and are ambulatory and live in selected Wisconsin community or surrounding communities.
- •Willing and able to give informed consent prior to study enrollment
- •Able to comply with study requirements.
排除标准
- •Prior receipt of 2016-17 influenza vaccine
- •Current participation in another clinical trial
- •Presence of a contraindication to influenza vaccine
研究组 & 干预措施
High Dose Influenza Vaccine
This group will be administered High Dose (HD) influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.
干预措施: High Dose Influenza vaccine (Biological)
Adjuvanted Influenza Vaccine
This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.
干预措施: Adjuvanted Influenza vaccine (Biological)
Standard Dose Influenza Vaccine+HD
This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year of the study and high dose influenza vaccine (0.5 mL intramuscular (IM) injection) in the second year of the study.
干预措施: High Dose Influenza vaccine (Biological)
Standard Dose Influenza Vaccine+HD
This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year of the study and high dose influenza vaccine (0.5 mL intramuscular (IM) injection) in the second year of the study.
干预措施: Standard Dose Influenza vaccine (Biological)
Standard Dose Influenza Vaccine +Adj
This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.
干预措施: Adjuvanted Influenza vaccine (Biological)
Standard Dose Influenza Vaccine +Adj
This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.
干预措施: Standard Dose Influenza vaccine (Biological)
Standard Dose Influenza Vaccine+Recomb
This group will be administered a standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.
干预措施: Standard Dose Influenza vaccine (Biological)
Standard Dose Influenza Vaccine+Recomb
This group will be administered a standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study.
干预措施: Recombinant Influenza vaccine (Biological)
结局指标
主要结局
HI Titers, HD vs. AD, Yr 2 Day 28 Post Vaccination
时间窗: Year 2, Day 28 post vaccination
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2017-18
HI Titers, HD vs. AD, Yr 1 Day 28 Post Vaccination
时间窗: Year 1, Day 28 post vaccination
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2016-17
HI Titers, HD vs. AD, Yr 1 Day 182 Post Vaccination
时间窗: Year 1, Day 182 post vaccination
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2016-17
HI Titers, HD vs. AD, Yr 1 Day 365 Post Vaccination
时间窗: Year 1, Day 365 post vaccination
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 365 days post vaccination 2016-17
HI Titers, HD vs. AD, Yr 2 Day 182 Post Vaccination
时间窗: Year 2, Day 182 post vaccination
Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2017-18
次要结局
- HI Response by Prior Season Vaccination, Yr 1, Day 365 Post Vaccination(Year 1, Day 365 post vaccination)
- MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination(Year 1, Day 365 post vaccination)
- Number of Participants With Vaccine Failure, Year 2(Year 2, Post season)
- HI Response by Prior Season Vaccination, Yr 1, Day 182 Post Vaccination(Year 1, Day 182 post vaccination)
- MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination(Year 1, Day 28 post vaccination)
- MN Titers (A/Hong Kong (Siat Cell)), HD vs. AD, Year 2, Day 28 Post Vaccination(Year 2, Day 28 post vaccination)
- HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 28 Post Vaccination(Year 2, Day 28 post vaccination)
- HI Response by Prior Season Vaccination, Yr 1, Day 28 Post Vaccination(Year 1, Day 28 post vaccination)
- MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination(Year 1, Day 182 post vaccination)
- HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 182 Post Vaccination(Year 2, Day 182 post vaccination)
- HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 28 Post Vaccination(Year 2, Day 28 post vaccination)
- HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 182 Post Vaccination(Year 2, Day 182 post vaccination)
- Number of Participants With Vaccine Failure, Year 1(Year 1, Post season)
研究者
Huong Nguyen, PhD
Research Scientist
Marshfield Clinic Research Foundation