A Randomized, Blinded, Placebo-controlled Study of Phase I Allantoic Split Inactivated Seasonal Influenza Vaccine in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
研究概览
简要总结
The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial that explored the safety and immunogenicity of single dose a allantoic split inactivated seasonal influenza vaccine in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers of both sexes aged 18-60 years.
- •Persons seronegative against A/H1N1 influenza virus, A/H3N2 and type B (with antibody titers ≤1: 10, according to hemagglutination-inhibition (HI) assay to determine).
- •Literate and willing to provide written informed consent.
- •A signed informed consent.
排除标准
- •Available in anamnaze volunteer at any allergic reactions.
- •Allergic reactions to chicken proteins, or any preceding vaccination.
- •Acute illness with a fever (37.0 C).
- •Vaccination against influenza in the 2012/2013 season.
- •Seropositive volunteers against A/H1N1 influenza virus, A/H3N2 and type B (with antibody titers greater than 1:10 according HI).
- •Current or recent (within two weeks of enrollment) acute respiratory illness with or without fever.
- •Hypersensitivity after previous administration of any vaccine.
- •History of chronic alcohol abuse and/or illegal drug use.
- •Any clinically significant abnormal laboratory finding.
- •A positive pregnancy test for all women of childbearing potential.
- •Administration of immunosuppressive drugs or other immune modifying drugs within 4 weeks prior to study enrollment.
- •Acute or chronic clinically significant pulmonary disease, cardiovascular disease, gastrointestinal disease, liver disease, neurological illness, liver disease, blood disease, skin disorder, endocrine disorder, neurological illness and psychiatric disorder as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives.
- •History of leukemia or any other blood or solid organ cancer.
- •Seropositive for HIV, hepatitis B surface antigen and/or hepatitis C antibodies.
- •Receipt of antivirals, antibiotics, immunoglobulins or other blood products within 4 weeks prior to study enrollment or planned receipt of such products during the period of subject participation in the study.
- •Participation in another clinical trial within the previous three months or planned enrollment in such a trial during the period of this study.
- •Subjects who are, in the opinion of the investigator, at significantly increased risk of non-cooperation with requirements of the study protocol.
结局指标
主要结局
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
时间窗: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days
The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
时间窗: Two hours
Participants recorded solicited injection site and systemic adverse events in a Subject Diary. Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis. Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting.
Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
时间窗: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose
Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Serious adverse events (SAEs), including abnormal laboratory findings
时间窗: Three weeks of receipt
Serious adverse events (SAEs) are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
次要结局
- Geometric Mean Fold Increase in HI Antibody Titer(Change from Baseline HI Antibody Titer at 21 days)
- Seroprotection Rate of HI Antibody Titer(Change from Baseline HI Antibody Titer at 21 days)
- Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer(Change from Baseline HI Antibody Titer at 21 days)