An Open(Part 1), Single-arm(Part 1), Randomized(Part 2), Double-blind(Part 2), Active-controlled(Part 2) Phase I/II Clinical Trial to Evaluate the Safety and Efficacy (Immunogenicity) of GC3111B in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Solicited adverse events occurring by day 14 after administration of the investigational product
研究概览
简要总结
This clinical trial consists of two parts: Part 1, which explores safety, and Part 2, which examines both safety and efficacy (immunogenicity). Part 1 is a single-center, open-label, single-group study, while Part 2 is designed as a multicenter, double-blind, randomized, active-controlled trial.
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 19 to 64 years old as of the date of written consent.
- •Individuals with no history of vaccination with a vaccine containing diphtheria, tetanus, or pertussis antigens within the past 2 years prior to administration of the investigational product.
排除标准
- •Individuals who have received a vaccine within 4 weeks prior to administration of the investigational product.
- •Individuals with a history of Tdap vaccination prior to administration of the investigational product.
- •Pregnant and breastfeeding women.
- •Individuals who have participated in other clinical trials involving investigational products/devices within 6 months prior to administration of the investigational product.
研究组 & 干预措施
GC3111B
Participants randomized to receive a single dose of GC3111B vaccine.
干预措施: GC3111B (Biological)
Boostrix®
Participants randomized to receive a single dose of Boostrix® vaccine.
干预措施: Boostrix® (Biological)
结局指标
主要结局
Solicited adverse events occurring by day 14 after administration of the investigational product
时间窗: 14 days after administration of the IP
Unsolicited adverse events occurring by day 28 after administration of the investigational product
时间窗: 28 days after administration of the IP
Acute adverse events occurring within 30 minutes after administration of the investigational product
时间窗: 30 minutes after administration of the IP
Serious adverse events (SAE) and adverse events of special interest (AESI) occurring up to 180 days after administration of the investigational product
时间窗: 180 days after administration of the IP
Clinically significant findings in vital signs, laboratory tests, 12-lead electrocardiograms, and physical examinations
时间窗: 28 days after administration of the IP
次要结局
- Antibody rates for diphtheria and tetanus on day 28 after administration of the investigational product(28 days after administration of the IP)
- Boosting response rates for diphtheria, tetanus, and pertussis on day 28 after administration of the investigational product(28 days after administration of the IP)
- Geometric mean concentrations (GMC) of antibodies against diphtheria, tetanus, and pertussis antitoxins (anti-PT, anti-FHA, anti-PRN) on day 28 after administration of the investigational product(28 days after administration of the IP)