A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of NBP607 (Trivalent Inactivated Cell Culture-derived Influenza Vaccine) in Healthy Adults and Elderly Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,155
- 主要终点
- Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigen
研究概览
简要总结
The purpose of this study is to describe the immunogenicity and safety of the cell culture-derived influenza vaccine compared with the egg-derived influenza vaccine among subjects.
To describe the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained pre-vaccination and 21 days post-vaccination.
To describe the safety, the time of onset and duration of local and systemic solicited adverse events are assessed and reported. Unsolicited adverse events and serious adverse events are collected and categorized throughout the study period.
详细描述
This is a multi-center, randomized, double-blind study in healthy adult and elderly subjects. Subjects receive a single dose of one of the influenza vaccine formulations and provide blood samples for immunogenicity assessment.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 19 years or older.
- •The subjects who give written consent to participate in the study voluntarily and are able to comply with all study requirements.
- •If female and capable of bearing children,subject has a negative urine pregnancy test result on screening and agrees to employ adequate birth control measures through the study period.
排除标准
- •Subjects who are hypersensitive to any component of vaccine, i.e., eggs, chicken or chicken products.
- •Subjects with immune deficiency disorder.
- •History of Guillain-Barre syndrome.
- •Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
- •Subjects who experienced fever within 24 hours before vaccination or with the febrile disease(exceeding 38.0℃) on screening day or with any acute respiratory infection.
- •Subjects who had received immunosuppressant or immune-modifying drug within 3 months before screening.
- •Subjects who had received blood products or immunoglobulin within 3 months before screening.
- •Subjects who had received influenza vaccination within 6 months prior to the screening.
- •Subjects who had received other vaccination within a month before screening, or those who had another vaccination scheduled within a month after study vaccination.
- •Subjects who had participated in other clinical trial within 4 weeks prior to study vaccination.
- •Subjects who had done blood donation within a week prior to study vaccination or planned blood donation within 7 months after study vaccination.
- •Subjects with clinically significant chronic disease or malignant cancer.
- •Pregnant women, breast-feeding women.
- •Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
结局指标
主要结局
Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigen
时间窗: Day 0 and Day 21 post-vaccination
* Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Post-Vaccination. * Percentage of Participants Achieving Seroconversion at Day 21 Post-Vaccination With Influenza Vaccine. * Pre- and Post- Vaccination Geometric Mean Ratio (GMR)
次要结局
- Immunogenicity in subjects with a pre-vaccination HI antibody titer <1:80(Day 0 and Day 21 post-vaccination)
- Immunogenicity compared to control group(Day 21 post vaccination, 6 months post vaccination)
- Clinical Laboratory Tests(Day 0 and Day 21 post vaccination)
- Percentage of participants with Severe Adverse Event (SAE)(During 6 months post-vaccination)
- Percentage of participants with Solicited Systemic Adverse Event (AE)(During 7 days post-vaccination)
- Long-term Immunogenicity(6 months post-vaccination)
- Percentage of participants with Solicited Local Adverse Event (AE)(During 7 days post-vaccination)
- Percentage of participants with Unsolicited Adverse Event (AE)(During 21 days post-vaccination)
- Vital Sign(Day 0 and Day 21 post vaccination)
- Physical Examination(Day 0 and Day 21 post vaccination)