Immunogenicity and Safety Among Adults of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)
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
- Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)
研究概览
简要总结
To describe the safety of the inactivated, split-virion influenza vaccine, 2008-2009 formulation.
To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine 2008-2009 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 is 18 years of age or older on the day of inclusion.
- •Participant willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
- •Participant in reasonably good health as assessed by the Investigator.
- •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 in the 72 hours preceding enrollment in the trial.
- •Clinically significant findings in vital signs (including temperature ≥ 99.5°F oral) or 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
- •Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.*
- •Immunocompromising condition 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 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 potential, 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.
- •Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial procedures.
- •Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
- •Prior personal history of Guillain-Barré syndrome. * Subjects enrolled into this study will not be prohibited from donating blood for non-interventional studies.
结局指标
主要结局
Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)
时间窗: 21 days post-vaccination
Seroconversion was defined as a four-fold rise in titers or greater from baseline. If the baseline titer value is \< 10, then 10 is used as the baseline value for the purposes of this calculation
Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation
时间窗: Day 0 and 21 days post-vaccination
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
时间窗: Days 0-3 post-vaccination
Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering
Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)
时间窗: 21 days post-vaccination
Seroprotection was defined as post-vaccination titer value of ≥ 1:40.
次要结局
未报告次要终点