Annual Study of Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2005-2006 Formulation)
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 Before and After Fluzone® Vaccination
研究概览
简要总结
To describe the safety during Days 0 to 21 following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone in subjects aged 18-59 years and subjects aged ≥ 60 years.
To describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone, in subjects aged 18-59 years and subjects aged ≥ 60 years.
To submit remaining available sera to the Center for Biologics Evaluation and Research (CBER) for further analysis by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.
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
- •Participant aged 18 years or older on the day of inclusion.
- •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.
- •For a woman, inability to bear a child or negative serum/urine pregnancy test.
排除标准
- •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 ≥ 99.5°F oral) in the 72 hours preceding enrollment in the trial.
- •Clinically significant findings in vital signs (including temperature ≥ 99.5°F oral) on review of systems.
- •Self-reported history of severe adverse event to any influenza vaccine.
- •Laboratory-confirmed influenza infection or 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
- •Vaccination planned in the 4 weeks following any trial vaccination.
- •Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.
- •Immunocompromising 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 6 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 posed a health risk to the subject if enrolled or interfered 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 potential, a positive urine pregnancy test, breast feeding, or not using a medically approved form of contraception for the duration of the trial.
- •Current abuse of alcohol or drug addiction that interfered with the subject's ability to comply with trial procedures.
- •Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
研究组 & 干预措施
Age 18 to 59 years
Participants aged 18 to 59 years at enrollment.
干预措施: Fluzone®: Influenza Virus Vaccine (Biological)
Age 60 years and older
Participants aged 60 years and older at enrollment.
干预措施: Fluzone®: Influenza Virus Vaccine (Biological)
结局指标
主要结局
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Before and After Fluzone® Vaccination
时间窗: 21 days post-vaccination
GMTs and their 95% Confidence Intervals are presented for each of the 3 antigens in Fluzone® vaccine (2005-2006 Formulation)
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
时间窗: Day 0 to 3 post-vaccination
次要结局
未报告次要终点