Demonstrate the Lot-to-lot Consistency of 3 Consecutive Batches and to Evaluate the Efficacy and Safety of GC FLU®Pre-filled Syringe Injection and 'GC FLU®Injection' Administration.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,139
- 主要终点
- GMT (Geometric Mean Titre) of HI antibody titrebefore vaccination (Day 0) and after vaccination
研究概览
简要总结
This study is aimed to confirm the lot-to-lot consistency of 3 consecutive batches of 'GC FLU® Pre-filled Syringe Injection' and 'GC FLU® Injection' in the lot-to-lot
详细描述
This is a Post-Marketing, Multicentre, Open, Randomized Phase 4 Clinical Study. Subjects who gave voluntary written informed consent to participate in the study were screened for eligibility in the study, and those who met the eligibility criteria were randomized in the investigational group.
An investigator assessed the effectiveness (immunogenicity) and safety of the study vaccine in each subject during his/her participation in the study.
Subjects were randomized (Visit 1) into the investigational group according to a randomization table previously generated, and were vaccinated with influenza split vaccine, 'GC FLU®Pre-filled Syringe Injection' and 'GC FLU®Injection'.
12 Assessments for HI titre to each strain of influenza were performed at Visit 1 (pre-vaccination), and at Visit 3 (21 days after vaccination) for the efficacy (immunogenicity) evaluation [Picture 1].For the safety assessment, subject diaries were handed out to subjects, who were instructed to record any adverse event emerging ager the receipt of study vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Healthy adults≥ 18 and < 65years of age who can be followed up for 21 days.
- •Depending on the part of the study that a subject was going to participate, age criteria were further divided as follows:
- •Lot-to-lot consistency study [PART A]: ≥ 18 to < 65 years of age Annual clinical trial [PART B]: ≥ 18 to < 65 years of age [adults]
- •65 years of age [elderly population]
- •Subjects who gave voluntary written consent to participate in the study, and are able to comply with the study requirements.
排除标准
- •Subjects with a known hypersensitivity of allergic reaction to eggs or egg products, to chicken or chichenproducts, to any component of the study vaccine, neomycin or gentanicin.
- •Subjects with immune system disorders, including immune deficiency disease.
- •Subjects with a history of Guillain-Barre syndrome.
- •Subjects with severe chronic disease (e.g., cardiovascular disease except for controlled hypertension, respiratory disease, metabolic disease, renal dysfunction or hemoglobinopathy, etc.) who in the investigator's opinion may have difficulty in participating in the study.
- •Subjects with haemophilia or receiving a treatment with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection.
- •Subjects who had acute fever with the body temperature exceeding 38.0 °C within 72 hours before vaccination with the study drug.
- •Subjects who had received other vaccinations within 7 days before vaccination with the study drug, or those who had another vaccination scheduled during the study.
- •Subjects who had received immunosuppressant or immune modifying drug within 3 months before vaccination with the study drug.
研究组 & 干预措施
influenza split vaccine
干预措施: GC FLU® Injection, GC FLU® Pre-filled Syringe Injection (Drug)
结局指标
主要结局
GMT (Geometric Mean Titre) of HI antibody titrebefore vaccination (Day 0) and after vaccination
时间窗: Day 21
次要结局
- Unsolicited adverse events occurring from the date of vaccination until 21 days after vaccination(Day 21)
- Solicited local adverse events (topical symptoms) and solicited general adverse events (systemic symptoms) occurring from the date of vaccination until 6 days after vaccination(Day 6)
- The percentage of subjects achieving HI antibody titre ≥ 1:40 following the receipt of vaccination (Seroprotection rate).(Day21)
- The percentage of subjects achieving HI antibody titre ≥ 1:40 following the receipt of vaccination(Seroprotection rate).(Day 21)
- The percentage of subjects achieving seroconversion for HI antibody (Seroconversion rate)(Day 21)
- GMT (Geometric Mean Titre) of HI antibody titre before vaccination (Day 0) and after vaccination(Day 21)