A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent Influenza Vaccine)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,299
- 试验地点
- 1
- 主要终点
- GMT rate of HI(Hemagglutination Inhibition) antibody for each strain
研究概览
简要总结
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III
详细描述
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent 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: over 19 )
- •Korean adults who agree with 21 days follow up after vaccination and good compliance to study procedures
- •Those who are able to comply with the requirements for the study
排除标准
- •Inability in written/verbal communication
- •Subjects who have participated in other interventional study within 30 days
- •Alcohol or drug abuse within 6 months
- •Who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6 months of enrollment
- •Disorders in immune function
- •History of Guillain-Barré syndrome
- •Disease/medications which are likely to cause any severe bleeding
- •Active infection or experience of fever (>38.0 ℃) within 72 hours following vaccination
- •Oral temperature >38.0 ℃ at the vaccination day
- •Erythema, tattoo, injury at shoulder (vaccination site)
- •Hypersensitivity with egg, chicken, or any of the vaccine components, or Neomycin, Gentamicin
- •Influenza vaccination within 6months
- •Any vaccination within 30 days
- •Concomitant medications/therapy such as immunosuppressants or immune modifying drugs, systemic corticosteroids, immunoglobulins, blood or blood- derived products, or anti-cancer chemotherapy or radiation therapy within3 months
- •Pregnant or breast-feeding women
- •Clinically significant underlying diseases or medical history at investigator's discretion
结局指标
主要结局
GMT rate of HI(Hemagglutination Inhibition) antibody for each strain
时间窗: Day 21 post vaccination
GMT (Active comparator) / GMT(Experimental)
Solicited adverse events following vaccination
时间窗: Day0 up to 21 Day post vaccination
Solicited injection site reactions: Pain, Tenderness, Erythema, Redness, Induration, and Swelling; Solicited systemic reactions: Fever, Sweating, Chill, Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia
Unsolicited adverse events following vaccination
时间窗: Day0 up to 21 Day post vaccination
It can be estimated by Toxicity Grading Scale for healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
SCR rate of HI(Hemagglutination Inhibition) antibody for each strain
时间窗: Day 21 post vaccination
Difference of SCR (Experimental and Active comparator)
次要结局
- SPR rate of HI(Hemagglutination Inhibition) antibody(Day 21 post vaccination)
- GMT rate of HI(Hemagglutination Inhibition) antibody for each strain(Day 21 post vaccination)
- SCR rate of HI(Hemagglutination Inhibition) antibody for each strain(Day0 up to 21 Day post vaccination)
- Abnormalities in physical examination, Vital signs, clinical laboratory tests(Day 21 post vaccination)
- SAE(Day 180 post vaccination)