Safety and Immunogenicity of Revaccination With Influenza Vaccine in Healthy Adult Subjects Aged 18 to 64 Years Who Were Previously Vaccinated With Fluzone ID or Fluzone IM
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,250
- 试验地点
- 45
- 主要终点
- Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine
研究概览
简要总结
The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine.
Primary Objective:
- To evaluate and describe the safety profile of revaccination with Fluzone ID for all participants.
Secondary Objective:
- To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.
详细描述
All participants, who previously received either Fluzone ID or Fluzone IM in Study FID31 (NCT 00772109), will receive one dose of either the same or the alternative vaccine.
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
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 64 years on the day of vaccination in study FID33
- •Enrolled in and completed study FID31 (NCT 00772109) and received the correct vaccine (Fluzone ID or Fluzone® IM) 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
- •For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination
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
- •For a woman of child-bearing potential: known pregnancy or positive serum/urine pregnancy test
- •Breast-feeding woman
- •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 (observational trials will be allowed)
- •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 surface (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 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, (those who have 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 will not be excluded).
- •Personal or family history of Guillain-Barré Syndrome
- •Temporary Exclusion Criteria:
- •A prospective subject should not be included in the study until the following conditions and/or symptoms are resolved:
- •Febrile illness (temperature ≥ 37.5°C [or ≥ 99.5°F]) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
- •Signs and symptoms of an acute infectious respiratory illness.
研究组 & 干预措施
Group 1: Fluzone ID After Fluzone ID
Participants will receive Fluzone intradermal (ID) following Fluzone ID in Study FID31
干预措施: Influenza Virus Vaccine USP Trivalent Types A and B (Biological)
Group 2: Fluzone IM After Fluzone ID
Participants will receive Fluzone intramuscular (IM) following Fluzone ID in Study FID31
干预措施: Influenza Virus Vaccine USP Trivalent Types A and B (Biological)
Group 3: Fluzone IM After Fluzone IM
Participants will receive Fluzone intramuscular (IM) following Fluzone IM in Study FID31
干预措施: Influenza Virus Vaccine USP Trivalent Types A and B (Biological)
Group 4: Fluzone ID After Fluzone IM
Participants will receive Fluzone intradermal (ID) following Fluzone intramuscular (IM) in Study FID31
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 Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine
时间窗: Day 0 through Day 7 post-vaccination
Solicited injection site reactions: Erythema (redness), Swelling, Induration, Pain, Pruritus, Ecchymosis. Solicited systemic reactions: Headache, Myalgia, Malaise, Shivering, Fever (temperature).
次要结局
- Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine.(Day 28 post-vaccination)
- Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine(Day 0 and Day 28 post-vaccination)
- Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine(Day 28 post vaccination)