Randomized, Double-blind, Active-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of GC3111 in Healthy Adults
试验速览
- 阶段
- 2 期
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- Solicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
研究概览
简要总结
The purpose of this study is to evaluate safety and efficacy (immunogenicity) of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19-64 years of age.
详细描述
To evaluate immunogenicity of GC3111 as tetanus, diphtheria and acellular pertussis (Tdap) vaccine in healthy adults.
To evaluate safety of GC3111 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged above 19 and under 64 at the time of screening
- •Subject without history of administrating vaccines including diphtheria, tetanus or whooping cough antigens within 2 years prior to administration of investigational drug
- •Subject who provided informed consent and assent forms
排除标准
- •Subject who received vaccine within 4 weeks prior to receiving study vaccine
- •Subject who received Tdap vaccine prior to receiving study vaccine
- •Subject with chronic cough history within 12 weeks before receiving study vaccine
- •Subject who is pregnant, lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence
- •Subject who participated in any other clinical study (investigational drug/equipment) within 6 months before receiving study vaccine
- •Subject with any condition that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures
结局指标
主要结局
Solicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
时间窗: Day 0 (pre-vaccination) to Day 14 (post-vaccination)
Unsolicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
时间窗: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Serious Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
时间窗: Day 0 (pre-vaccination) to Day 180 (post-vaccination)
Vital Signs
时间窗: Day 0 (pre-vaccination), Day 28 (post-vaccination)
Blood Pressure (systolic, diastolic) in mmHg
Laboratory Examinations
时间窗: Screening (pre-vaccination), Day 28 (post-vaccination)
Blood Test (WBC with differential count (lymphocyte, monocyte etc.), RBC, hemoglobin, hematocrit, platelet count
次要结局
- Ratio of Participants With Antibody Responses (Boosting Response rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine(Day 0 (pre-vaccination) to Day 28 (post-vaccination))
- Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens(Day 28 (post-vaccination))
- Ratio of Participants with Antibody Responses (Seroprotection rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine(Day 0 (pre-vaccination) to Day 28 (post-vaccination))
- Geometric Mean Ratio (GMR) of Post-vaccination versus Pre-vaccination antibody concentrations for Diphtheria, Tetanus and Acellular Pertussis Antigens(Day 0 (pre-vaccination) to Day 28 (post-vaccination))