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
- Vital Signs
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
研究组 & 干预措施
GC3111 Vaccine Group
Participants randomized to receive a single dose of GC3111 vaccine (Biological: GC3111 vaccine).
干预措施: GC3111 vaccine (Biological)
Boostrix® Vaccine Group
Participants randomized to receive a single dose of Boostrix® vaccine (Biological: Boostrix® vaccine).
干预措施: Boostrix® vaccine (Biological)
结局指标
主要结局
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
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)
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))