NCT01750814已完成3 期
A Phase III, Randomized, Double-blind, Multi-center Study to Compare the Immunological Efficacy and Safety of GC3102C With GC FLU Inj. Administered Intramuscularly in Healthy Adults
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 主要终点
- GMT, using the Hemagglutination inhibition(HI) antibody titer
研究概览
简要总结
The primary objective is to demonstrate the immunological non-inferiority between GC3102C and GC FLU inj. influenza vaccines by assessing geometric mean titers(GMTs) 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults, 18 to <60 years old
- •Subjets willing to provide written informed consent and able to comply with the requirements for the study
排除标准
- •Subjects with a history of hypersensitivity, especially anaphylactic reactions to egg, egg proteins, chicken or components of vaccine such as gentamicin, gelatin, and arginine
- •Subjects with a history of Guillain-Barré syndrome
- •Subjects with severe chronic diseases (e.g., cardiovascular diseases without controllable hypertension, hemoglobinopathy, respiratory, metabolic, and renal disorders) who are considered by the investigator to be ineligible for the study
- •Subjects previously treated with anti-coagulant therapy or hemophiliac patients who may be at risk of severe hemorrhage after an intramuscular injection
- •Subjects who have had an acute febrile (at least 38.0°C) episode at some time during the 72 hours before enrollment
- •Subjects who have received a vaccination within 7 days before enrollment or who are scheduled for another vaccination (excluding the study vaccine) during the study
- •Immunocompromised subjects with immunodeficiency diseases or those who are receiving immunosuppressive or immunomodulatory therapy, e.g., azathioprine, cyclosporin, interferon, granulocyte-colony stimulating factor, tacrolimus, everolimus, sirolimus
- •Subjects who have received high-dose corticosteroids in the 3 months before vaccination or who will be administered a cumulative dose of 700 mg of corticosteroids during the study. Inhaled, intranasal, and local application of corticosteroids is permitted, regardless of dosage, and corticosteroids such as prednisolone at a maximum dose of 15 mg/day are allowed
- •Subjects who have been administered immunoglobulins or blood-derived products 3 months before enrollment or who are scheduled for the administration during the study
- •Subjects who have received an influenza vaccine within 6 months of enrollment
- •A female subject who is pregnant or who is breast-feeding. Subjects of childbearing potential without an appropriate contraceptive measure within 30 days before enrollment and who do not agree to use a clinically acceptable method of birth control during the study (e.g., oral contraceptives, condom, diaphragm or intrauterine device, or vasectomy of male partner)
- •Subjects who have participated in any other clinical trials within 30 days of the administration of the study vaccine
- •Individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study
结局指标
主要结局
GMT, using the Hemagglutination inhibition(HI) antibody titer
时间窗: Day 21
次要结局
- Number of Participants Reporting a Unsolicited Adverse Events After Vaccination(Day 21)
- Rate of subjects achieving seroprotection(Day 21)
- Rate of subjects achieving seroconversion(Day 0 , Day 21)
- Number of Participants Reporting a Solicited Adverse Events After Vaccination(Day 6)
研究者
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