NCT02658409Unknown3 期
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study to Investigate the Efficacy (Immunogenicity) and Safety of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 1,630
- 试验地点
- 1
- 主要终点
- The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the GMT ratio
研究概览
简要总结
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study.
详细描述
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study to Investigate the Efficacy (Immunogenicity) and Safety of GC3106 (quadrivalent cell-culture based influenza vaccine) after Intramuscular Administration in Healthy Subjects.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Given written informed consent
- •Healthy Korean adults (age: between over 19)
- •Women of childbearing age with negative Urine hCG in screening visit
排除标准
- •Subjects unable to communicate (illiterate or who cannot understand the questionnaire and/or the study subject diary)
- •Subjects participating in another clinical study or has participated in a clinical study in the last 30 days (the participation should be based on the final dose of the investigational drug)
- •Subjects with impaired immune functions that include immune deficiency diseases
- •Subjects with a history of Guillain-Barre syndrome
- •Hemophilia patients at risk of serious bleeding with intramuscular injection or who had taken an anticoagulant
- •Subjects with symptoms of active infection or who had higher than 38.0℃ fever before the investigational product administration
- •Subjects to be planned to have a surgery in the study duration or subject who the investigator decides exception because of a clinical significant chronic or malignant disease or medical history to interrupt the study procedure
- •Subjects with erythema and/or a tattoo in the injection site of the scheduled investigational product (the deltoid muscle) that is hard to identify the topical toxicity
- •Subjects with a history of allergic reaction to eggs or chicken, the vaccine components, and/or Formaldehyed, Gentamicin and Sodium Deoxychloate
- •Subjects who had been administered the influenza vaccine 6 months before the scheduled vaccination of the investigational product
- •Subjects who had been vaccinated with another vaccine within 30 days before the investigational product administration or had a scheduled vaccination during the clinical study period
- •Subjects who had received an immunosuppressant, immunity-modifying drug, cytotoxic chemotherapy that can affect his or her immune system, or radiation therapy within 3 months before the investigational product administration
- •Subjects receiving systemic steroids (more than 20 mg/day of prednisolone administered everyday over 14 days or more than 700 mg of a cumulative dose during the same period of time) within 3 months before the administration (Day 1) of the investigational product (topical ointments, eye drops, inhalants or intranasally/intramuscularly administered drugs, or topically applied drugs such as ligaments; unless administered every other day over 14 days)
- •Subjects who had received immunoglobulin or a blood-derived product within 3 months before being vaccinated with the investigational product or is scheduled to receive those products during the clinical study period
- •Pregnant women, nursing mothers, or women of childbearing age who do not perform adequate contraception (using a condom, diaphragm, IUD, or hormonal contraception 21 days before vaccination with the investigational product or whose male partner had undergone a vasectomy)
- •Subjects who have other clinically significant medical or psychiatric examination findings deemed by the investigator to make them ineligible for participation in this clinical study
研究组 & 干预措施
GC3106(quadrivalent)
Experimental
0.5ml, intramuscular, a single dosing
干预措施: GC3106(quadrivalent cell-culture based influenza vaccine) (Biological)
Fluarix™tetra Syringe Inj.(Quadrivalent)
Active Comparator
0.5ml,intramuscular,a single dosing
干预措施: Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine) (Biological)
结局指标
主要结局
The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the GMT ratio
时间窗: Day 21 post vaccination
(GMT control drug/ GMT test drug)
The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the difference between the SCRs
时间窗: Day 21 post vaccination
(SCR control drug- SPR test drug)
Solicited adverse events: Day 0~Day 6
时间窗: Day 0~Day 6
Unsolicited adverse events: Day 0~Day 21
时间窗: Day 0~Day 21
次要结局
- For 180 days after Visit 1, serious adverse events were presented with the results.(For 180 days after Visit 1)
- Rate of subjects achieving seroconversion, defined as post vaccination HI antibody titers(21 days after vaccination)
- Rate of subjects achieving seroprotection, defined as post vaccination HI antibody titers(21 days after vaccination)
- Vital sign and physical examination(For 180 days after Visit 1)
研究者
研究点 (1)
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