A Single-center, Randomized, Active-controlled, Parallel-group, Open-label, Phase I Study to Evaluate Safety and Immunogenicity of Single Injection of LBVD or Eupenta Co-administered With Imovax Polio in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Number of subjects with immediate reactions
研究概览
简要总结
This is a single-center, randomized, active-controlled, parallel-group, open-label, phase I study to evaluate safety and immunogenicity of single injection of LBVD or Eupenta co-administered with Imovax Polio 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
- None
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 adults between 19 and 55 years of age at the time of Visit 1 (Screening)
- •Persons who or whose legal representatives have voluntarily signed an informed consent after receiving explanation about the objectives, methods, effects, etc. of the clinical study
- •Persons who are surgically sterile, postmenopausal women, or agree to use contraceptive measures
排除标准
- •Persons who have an experience of participation in another interventional clinical study within 3 months prior to Visit 1 (Screening)
- •Persons who have a record of vaccination with the tetanus toxoid (TT)/tetanus diphtheria (Td)/tetanus diphtheria pertussis (Tdap) vaccine or other vaccines containing tetanus-diphtheria for adults or who are suspected to have been vaccinated with either of them within 5 years prior to Visit 1 (Screening)
- •Persons who were vaccinated within 4 weeks prior to Visit 1 (Screening) or who are scheduled to be vaccinated with the vaccines other than the study vaccine during the study period
- •Persons with a history of diphtheria, tetanus, pertussis, hepatitis B virus, polio virus, or the invasive diseases caused by Haemophilus influenzae type b
研究组 & 干预措施
Test group
DTP-HepB-IPV-Hib vaccine
干预措施: DTP-HepB-IPV-Hib vaccine (Biological)
Control group
DTP-HepB-Hib vaccine & IPV
干预措施: DTP-HepB-Hib vaccine & IPV (Biological)
结局指标
主要结局
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 14 days after the vaccination [Day 1-15]
Solicited adverse events are classified into the local(pain, tenderness, erythema/redness, induration/swelling) and systemic(fever, fatigue, chills/shivering, myalgia, headache, arthralgia, decreased appetitie, diarrhea, nausea/vomiting, rash) signs and symptoms.
Number of subjects with any 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 immediate reactions after vaccination with the study vaccine and the solicited adverse events.
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 have shown 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))