Randomized, Double-blinded, Controlled, Phase I Trial to Assess Safety, Tolerability and Immunogenicity of 'NBP607(Trivalent Inactivated Cell-Culture Influenza Vaccine)' Compared to Egg-based Influenza Vaccine in Healthy Adult
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Incidence rate of solicited local adverse events (AEs)
研究概览
简要总结
A randomized, double-blinded, controlled, Phase I clinical trial to assess the safety, tolerability and immunogenicity of 'NBP607(trivalent inactivated cell-culture influenza vaccine)' compared to egg-based influenza vaccine in healthy adult volunteers
详细描述
- Assessment of Safety
- Assessment of Immunogenicity
- Estimated Enrollment: 100
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
- 20 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20 to <60 years of age
- •able and willing to give written informed consent prior to study entry
- •if female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening
排除标准
- •hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
- •Immunodeficiency disease
- •history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
- •thrombocytopenia or Coagulation disorders
- •experienced fever (>37.5°C) within the past 24 hours or any acute respiratory infection
- •receipt of Immunosuppressants or Immunomodulators within the past 3 months
- •receipt of blood products or immunoglobulin within the past 3 months
- •received influenza vaccine within the past 6 months
- •received another vaccine within the past 1 month or plans vaccination within 1 months following the study vaccination
- •participation on another clinical trial within 1 month prior to the study vaccination
- •history of blood donation within 1 week prior to the study vaccination for plan of blood donation within 7 days following the study vaccination
- •any chronic diseases that interfere with the clinical trial or Malignant tumors
- •pregnant or breastfeeding
- •any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might interfere with the safety of the study subject.
研究组 & 干预措施
Group 2
Agrippal 0.5ml
干预措施: Agrippal (Biological)
Group 1
NBP607 0.5ml
干预措施: NBP607 (Biological)
结局指标
主要结局
Incidence rate of solicited local adverse events (AEs)
时间窗: Within 21 days after vaccination
All AEs were classified and analyzed according to its severity and causality. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
Incidence rate of solicited systemic AEs
时间窗: Within 21 days after vaccination
All AEs were classified and analyzed according to its severity and causality. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
Incidence rate of unsolicited AEs
时间窗: Within 21 days after vaccination
All AEs were classified and analyzed according to its severity and causality. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
Pulse rate at each visit
时间窗: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Comparisons within each group between pre-/post- vaccination were summarized and presented.
Blood pressure(systolic/diastolic) at each visit
时间窗: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Comparisons within each group between pre-/post- vaccination were summarized and presented.
Body temperature at each visit
时间窗: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Comparisons within each group between pre-/post- vaccination were summarized and presented.
Rate of normal/abnormal results in Electrocardiogram (ECG) (ventricular rate, PR interval, QRS, QT, and QTc) collected during screening visit and close-out visit
时间窗: Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
Comparisons within each group between pre-/post- vaccination were summarized and presented.
Rate of normal/abnormal results in physical examination at each visit
时间窗: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Comparisons within each group between pre-/post- vaccination were summarized and presented.
Rate of normal/abnormal results in clinical laboratory tests(Platelet, Cl, etc.) during screening visit and close-out visit
时间窗: Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
Comparisons within each group between pre-/post- vaccination were summarized and presented.
次要结局
- Seroprotection rate measured by post-vaccination HI titer[Immunogenicity](21-28 days after vaccination)
- Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity](21-28 days after vaccination)
- Seroconversion rate measured by pre-/post-vaccination Haemagglutination Inhibition (HI) titer[Immunogenicity](21-28 days after vaccination)