Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011, in Non-Elderly Adult and Elderly Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- The primary objective is to evaluate the immunogenicity profiles for influenza virus vaccine strains (2010-2011 season) of the AdimFlu-S manufactured by Adimmune Corporation.
研究概览
简要总结
Each potential subject will be screened before the start of the study to determine their eligibility for participation. Just prior to vaccination, a 10 mL venous blood sample will be taken from each eligible subject, for baseline titration of circulating anti-HA antibodies. Immediately thereafter, each subject received one dose of vaccine (0.5 mL) by intramuscular injection into the upper arm. Subjects will be asked to stay at the site for 30 minutes post-vaccination to observe for immediate reaction. Subjects will be monitored for adverse events during the study. At three weeks (±3 days) after the vaccination, subjects will be asked to return to the site for final collection of blood samples.
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
- •Males and non-pregnant females and aged ³ 18 years;
- •Willing and able to adhere to visit schedules and all study requirements;
- •Subjects read and signed the study-specific informed consent.
排除标准
- •Subject or his/her family is employed by the participated hospital;
- •Subjects received influenza vaccine (Trivalent and/or A(H1N1)) within the previous 6 months;
- •History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
- •Personal or family history of Guillain-Barré Syndrome;
- •An acute febrile illness within 1 week prior to vaccination;
- •Current upper respiratory illness (URI), including the common cold or nasal congestion within 72 hours;
- •Patients with influenza-like illness as defined by the presence of fever (temperature ≥38ºC) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
- •Female subjects who are pregnant, lactating or likely to become pregnant during the study; Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.
- •Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
- •Immunodeficiency, immunosuppressive or household contact with immunosuppression;
- •History of wheezing or bronchodilator use within 3 months prior to study vaccine;
- •Receipt of live virus vaccine within 1 month prior to study vaccine or expected receipt within 1 month of study vaccination;
- •Receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt within 1 month of study vaccination;
- •Receipt of any blood products, including immunoglobulin in the prior 3 months;
- •Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine;
- •Significant chronic illness for which inactivated influenza vaccine is recommended or commonly used.
研究组 & 干预措施
AdimFlu-S Influenza Vaccine
干预措施: AdimFlu-S Vaccine 2010-2011 (Biological)
结局指标
主要结局
The primary objective is to evaluate the immunogenicity profiles for influenza virus vaccine strains (2010-2011 season) of the AdimFlu-S manufactured by Adimmune Corporation.
时间窗: Change from baseline for anti-hemaglutinin (HA) antibodies by hemagglutinaton inhibition (HAI) at 21 days post immunization
Twenty-one days after vaccination, serum samples will be taken and tested for anti-hemaglutinin (HA) antibodies by hemagglutinaton inhibition (HAI), and assays will be performed at Adimmune Corporation designated central laboratory. Subjects will be considered to be seronegative if serum HAI titer\<1:10. The seroconversion is defined as the post-vaccination serum at least 40 for whom had negative pre-vaccination or a fourfold or greater increase in HAI titers in subjects who had positive pre-vaccination serum.
次要结局
- The secondary objective is to evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S manufactured by Adimmune Corporation.(7 days after vaccination)