Lot Consistency, Immunogenicity, and Safety Study of Three Lots of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® Administered Intramuscularly in Adult Subjects Aged 18 to 64 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,292
- 试验地点
- 49
- 主要终点
- Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
研究概览
简要总结
This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route.
Primary Objective:
- To demonstrate lot consistency of the Fluzone ID manufacturing process.
- To provide information concerning the immune response of Fluzone ID.
Secondary Objectives:
Safety
- To describe the safety profile of subjects who receive of Fluzone ID.
详细描述
Three lots of the investigational Fluzone vaccine with the 2008/2009 Northern Hemisphere formulation will be administered intradermally (ID) using the Becton Dickinson Micro Injection System.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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.
- •Informed consent form signed and dated.
- •Able to attend all scheduled visits and to comply with all trial procedures.
- •For women 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.
- •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.
- •Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine.
- •Thrombocytopenia or bleeding disorder in the 3 weeks preceding inclusion.
- •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, and 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
Fluzone Intradermal Vaccine Lot 1
Participants will receive a dose of Influenza intradermal vaccine Lot 1
干预措施: Influenza Virus Vaccine USP Trivalent Types A and B (Biological)
Fluzone Intradermal Vaccine Lot 2
Participants will receive a dose of Influenza intradermal vaccine Lot 2
干预措施: Influenza Virus Vaccine USP Trivalent Types A and B (Biological)
Fluzone Intradermal Vaccine Lot 3
Participants will receive a dose of Influenza intradermal vaccine Lot 3
干预措施: Influenza Virus Vaccine USP Trivalent Types A and B (Biological)
Fluzone Intramuscular Vaccine
Participants will receive a dose of influenza intramuscular vaccine
干预措施: Influenza Virus Vaccine USP Trivalent Types A and B (Biological)
结局指标
主要结局
Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
时间窗: 28 Days post-vaccination
The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and post-vaccination titer of ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum of four-fold increase 28 days post-vaccination.
Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines
时间窗: Baseline (Day 0) and 28 Days post-vaccination
The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay
次要结局
- Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM(Before and 28 Days post-vaccination)
- Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine(Day 0 up to 7 Days post vaccination)