NCT05229536已完成2 期
A Single-center, Randomized, Double-blind, Parallel Control Phase II Clinical Trial to Evaluate Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged From 3 to 35 Months
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- Safety study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by the occurrence of adverse events
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 35 years.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People aged 3-35 months;
- •Subject who has not been vaccinated with meningococcal group A and C conjugate vaccine, meningococcal group A polysaccharide vaccine and meningococcal group A and C and haemophilus b conjugate vaccine at the aged of 3-11 months, and who have't given boost immunity above 1 year old, and they all meet the physical examination requirements of the project;
- •Infants aged 3-11 months should be full-term (37-42 weeks of gestation) and their birth weight should meet the requirements (2500g ≤ body weight ≤ 4000g);
- •The guardian signs the informed consent form;
- •The guardian and his family agree to comply with the requirements of the clinical trial protocol;
- •Subject who had no history of other live vaccines within 14 days before vaccination and no history of other inactivated vaccines within 7 days;
- •Axillary body temperature ≤ 37.0 ℃.
排除标准
- •History of severe allergic reactions requiring medical intervention (such as swelling of mouth and throat, dyspnea, hypotension or shock);
- •Have a history of allergy to the vaccine or vaccine ingredients (especially those allergic to tetanus toxoid), or have a history of other serious adverse reactions to the vaccine;
- •A clearly diagnosed history of thrombocytopenia or other coagulation disorders that may cause contraindications to intramuscular injection;
- •Abnormal production process, asphyxia rescue history, or congenital malformation, developmental disorder or serious chronic disease;
- •Has serious cardiovascular, liver and kidney diseases or congenital abnormalities and HIV infection;
- •Suffer from encephalopathy, uncontrolled epilepsy, convulsion and other progressive nervous system diseases;
- •Acute disease, severe chronic disease, acute attack of chronic disease and fever (axillary body temperature ≥ 38.0 ℃) in the past 3 days;
- •Plan to participate or be participating in any other drug clinical research;
- •The interval between the first dose of test vaccine and meningococcal group A polysaccharide vaccine is less than 28 days;
- •According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.
结局指标
主要结局
Safety study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by the occurrence of adverse events
时间窗: 30 day after each vaccination
Evaluate the incidence of adverse reactions for Meningococcal ACYW135 Polysaccharide Conjugate Vaccine
Immunogenicity study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by positive conversion rate
时间窗: 30 day after each vaccination
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
3 期
Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 5 MonthsMeningitis, MeningococcalNCT05252715Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd1,200
进行中（未招募）
3 期
Immunogenicity and Safety of MCV4 in Volunteers Aged 6 Months-5 YearsHealthy PopulationNCT06314685Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd2,450
Unknown
3 期
Safety and Immunogenicity Study of ACYW135 Meningococcal Polysaccharide Vaccine Aged 2-50 Years OldACYW135 Meningococcal Polysaccharide VaccineNCT02869672Beijing Chaoyang District Centre for Disease Control and Prevention1,200
已完成
2 期
Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 002MeningitisNCT01661738Hualan Biological Engineering, Inc.360
进行中（未招募）
3 期
Immunogenicity and Safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in Volunteers Aged 3-5 MonthsHealthy PopulationNCT06314659Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd630