Annual Study of Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine
时间窗: Day 0 and Day 21 Post-Vaccination
GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation.
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
时间窗: 0 to 3 days post-vaccination
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
Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination
时间窗: 21 Days post-vaccination
Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination
时间窗: Day 21 post-vaccination
次要结局
未报告次要终点