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
干预措施
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
研究组 & 干预措施
GC FLU inj.
Active Comparator
Influneza vaccine, single-dose vial
干预措施: GC FLU inj. (Biological)
GC3102C
Experimental
Influneza vaccine, multi-dose vial
干预措施: GC3102C (Biological)
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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