Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine
Annual Study of Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005
To observe and to describe the safety during Days 0 to 21 following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years.
To measure and to describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.
研究概览
详细说明
The time of onset and duration of local and systemic solicited reactions will be assessed and reported. Unsolicited adverse events (including serious adverse events) will be collected and categorized throughout the study period.
Antibody levels will be evaluated by hemagglutination inhibition (HI) assay from sera obtained pre-vaccination (Day 0) and 21 days post-vaccination, for antigens from the 2004-2005 influenza virus strains: A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2), and B/Jiangsu/10/2003.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Virginia
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Norfolk、Virginia、美国、23507
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria :
- Participant aged 18 years or older.
- Participant able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
- Participant is in reasonably good health as assessed by the investigator.
- Participant willing and able to meet protocol requirements.
- Participant willing and able to give informed consent.
Exclusion Criteria :
- Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
- An acute illness with or without fever (temperature >100.4°F) in the 72 hours preceding enrollment in the trial.
- Clinically significant findings in vital signs (including temperature >100.4°F) on review of systems.
- Self-reported history of severe adverse event to any influenza vaccine.
- Vaccination against influenza in the 6 months preceding enrollment in the study.
- Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.
- Participation in any other experimental drug or vaccine trial within the 30 days preceding enrollment into the study.
- Immunogenicity or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 3 months.
- Receipt of blood or blood products within the 3 months preceding enrollment in the study.
- Diabetes mellitus requiring pharmacological control.
- Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled, or could interfere with the evaluation of the vaccine.
- Person deprived of freedom by an administrative or court order (having legal or medical guardian).
- For women of childbearing age, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Fluzone® Vaccine Group - Age 18-59 Years
Participants aged 18 to 59 years at enrollment and received 1 dose of Fluzone® Vaccine
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0.5 mL, Intramuscular
其他名称:
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实验性的:Fluzone® Vaccine Group - Age ≥ 60 Years
Participants aged at least 60 years or older at enrollment and received 1 dose of Fluzone® Vaccine
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0.5 mL, Intramuscular
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
大体时间:0 to 3 days post-vaccination
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Solicited local reactions: Erythema (redness), Induration, Bruising, and Pain at the injection site. Solicited systemic events: Fever (temperature), Chills, Rash, Headache, Cough, Runny nose, Nausea, Vomiting, Diarrhea, Malaise, Myalgia, and Arthralgia |
0 to 3 days post-vaccination
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Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine
大体时间:Day 0 and Day 21 Post-Vaccination
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GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation.
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Day 0 and Day 21 Post-Vaccination
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Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination
大体时间:21 Days post-vaccination
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21 Days post-vaccination
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Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination
大体时间:Day 21 post-vaccination
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Day 21 post-vaccination
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合作者和调查者
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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