A Single-center, Randomized, Active-controlled, Parallel-group, Double-blind, Phase I Clinical Trial to Evaluate Safety and Immunogenicity of Hexavalent Vaccine (APV006) in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 主要终点
- Number of subjects with unsolicited adverse events
研究概览
简要总结
This is a single-center, randomized, active-controlled, parallel-design, double-blind, phase I study to evaluate the safety and immunogenicity of a single dose of APV006 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
- Double (Participant, Investigator)
盲法说明
The study pharmacist and study staff who administer the investigational vaccine (e.g., medication nurse) will not be blinded in this study since a control vaccine that can be visually distinguished from the study vaccine will be used. The study staff including the investigator will remain blinded, except the unblinded staff.
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female adults aged 19 - 55 on Visit 1
- •Those without clinically significant abnormalities on the screening test on Visit 1
- •Those with a confirmed BMI of 18.5 kg/m2 to less than 30 kg/m2 on Visit 1
- •Those who have heard a detailed explanation of the study and whose written consent to participate in the study was given voluntarily by themselves or their legal representatives
排除标准
- •Those who participated in other studies and took investigational products/ investigational vaccines within 6 months from Visit 1
- •Those who took tetanus toxoid (TT), tetanus-diphtheria (Td), tetanus-reduced diphtheria-acellular pertussis (Tdap) vaccine for adults, or other vaccines containing tetanus-diphtheria for adults within 5 years from Visit 1
- •Those who were vaccinated within 4 weeks from Visit 1 or who plan to receive vaccines other than the investigational vaccine from the participation in this study to Visit 5
- •Have had diphtheria, tetanus, pertussis, hepatitis B, polio, or invasive diseases caused by Haemophilus influenzae type b
结局指标
主要结局
Number of subjects with unsolicited adverse events
时间窗: For 28 days (+7 days of window period) after the vaccination [Day 1-29]
Unsolicited adverse events mean all the adverse events excluding the solicited adverse events that occur after the ICF is obtained until 28 days after vaccination.
Number of subjects with immediate reactions
时间窗: For 30 minutes after the vaccination
Immediate reactions after vaccination with the study vaccine mean all the signs and symptoms occurring within 30 minutes after the vaccination.
Number of subjects with solicited adverse events
时间窗: For 7 days after the vaccination [Day 1-8]
Solicited adverse events are classified into the local(pain, tenderness, erythema/redness, induration/swelling, pruritus) and systemic(fever, fatigue, chills/shivering, myalgia, headache, arthralgia, decreased appetite, diarrhea, nausea/vomiting, hypersensitivity) signs and symptoms.
Number of subjects with serious adverse events
时间窗: For 181 days (+7 days of window period) after the vaccination [Day 1-181]
serious adverse events that occur after the ICF is obtained until 6 months after vaccination.
次要结局
- GMC or GMT values for each antigen prior to and 28 days post-vaccination with the study vaccine (Day 29)(Day 29 (+7 days window period))
- Proportions of the subjects who meet seroprotection/vaccine-response to each antigen and the subjects who have shown seroconversion 28 days post-vaccination with the study vaccine (Day 29) compared to pre-vaccination.(Day 29 (+7 days window period))
- Proportion of the subjects who meet one of the following regarding anti-PT, anti-FHA, and anti-PRN(Day 29 (+7 days window period))