Safety and Immunogenicity of Revaccination With Influenza Vaccine in Ambulatory Elderly Subjects Previously Vaccinated With Fluzone ID, Fluzone HD, and Fluzone® IM
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 807
- 试验地点
- 28
- 主要终点
- Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
研究概览
简要总结
This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years.
Primary Objective:
To describe the safety profile for all subjects.
Secondary Objective:
To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.
详细描述
Subjects who previously participated in study FID29 will be invited to participate in this revaccination study. They will be assigned to 1 of 3 groups based on the group they were previously randomized to and the vaccine received in study FID29.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 65 years on the day of vaccination
- •Enrolled in and completed study FID29 and received the correct vaccine for the group to which they were randomized
- •Informed consent form signed and dated
- •Able to attend all scheduled visits and to comply with all trial procedures
- •Subject is medically stable.
排除标准
- •Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
- •Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination
- •Planned participation in another clinical trial during the present trial period
- •Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- •Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
- •Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
- •Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
- •Receipt of any vaccination in the 4 weeks preceding the trial vaccination
- •Planned receipt of any vaccine in the 4 weeks following the trial vaccination
- •Known human immunodeficiency virus (HIV), hepatitis B (HBs) antigen, or Hepatitis C seropositivity.
- •Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine
- •Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination
- •Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- •Neoplastic disease or any hematologic malignancy, (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, as well as subjects who have a history of neoplastic disease and who have been disease free for ≥ 5 years).
- •Personal or family history of Guillain-Barré Syndrome.
研究组 & 干预措施
Group 1b: Fluzone IM After Fluzone ID
干预措施: Influenza Virus Vaccine USP Trivalent Types A and B (Biological)
Group 2a: Fluzone IM After Fluzone IM
干预措施: Influenza Virus Vaccine USP Trivalent Types A and B (Biological)
Group 2b: Fluzone ID After Fluzone IM
干预措施: Influenza Virus Vaccine USP Trivalent Types A and B (Biological)
Group 3: Fluzone HD After Fluzone HD
干预措施: Influenza Virus Vaccine USP Trivalent Types A and B (Biological)
Group 1a: Fluzone ID After Fluzone ID
干预措施: Influenza Virus Vaccine USP Trivalent Types A and B (Biological)
结局指标
主要结局
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
时间窗: Days 0 through 7 post vaccination
Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.
次要结局
- Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection(Day 0 and Day 28 post-vaccination)
- Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine(Day 28 post vaccination)
- Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine(Days 0 and 28 post-vaccination)