A Single-center, Open Trials to Evaluate the Safety of Freeze-dried Group ACYW135 Meningococcal Conjugate Vaccine
试验速览
- 阶段
- 1 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- systemic and local reactions 30 days after full-course vaccination
研究概览
简要总结
Safety Evaluation of freeze-dried Group ACYW135 Meningococcal conjugate vaccine in healthy people above 2-months-old
详细描述
There are five different age groups(18~55 years/7~17 years/1~6 years/7~10 months/2 months),each group has 40 people and divided into two subgroups. Each subgroup will inject different vaccine(MCV4 4μg,MCV4 8μg).For 7~10 months&2 months age groups,there are 2&3 injection seperately. Each injection interval is 1 months.
After 7 days observation of 1 dose immunization in Group 18-55 years old adults, if there are no serious adverse events associated with vaccines, or severe adverse reactions rate is less than 10%, 7 to 17 years old and 1 to 6 years old age groups will continue to inoculate in order. After the first dose of 7~10 months group and evaluating safety, 2 months group immunized the first dose. All participants completed the immune procedure, then observed the safety to 30 days after whole immunization.
Data collection: Subjects completed diary card, the researchers collected original data and fill out the case report form for data entry and statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants unimmunized Group A&C meningococcal conjugate vaccine or Group A meningococcal polysaccharide vaccine which is above 2~11 months-old, and healthy toddler more than 1-year-old without booster immunization.
- •The guardian or himself informed consent, and signed the informed consent form;
- •The guardian and family agreed to abide by the requirements of clinical trial scheme;
- •Participants has no history of immunoglobulin vaccination in the last 2 months / 2 months-old infants has no history of immunoglobulin vaccination after born, there is no history of other live vaccine inoculation before vaccination in 14 days, within 7 days without other inactivated vaccine immunization history;
- •the axillary temperature < 37.1 ℃;
- •2-months-old group in the age of 61-90 days;
- •7-months-old group in the age of 211-300 days;
- •1-year-old group in age of one full year of life.
排除标准
- •Have allergies, convulsions, seizures, encephalopathy and psychiatric history or family history;
- •Neomycin, streptomycin and polymyxin B allergies;
- •With immunodeficiency, immunosuppressant therapy;
- •History of meningitis;
- •Women in lactation or pregnant;
- •Acute febrile diseases and infectious diseases;
- •History of labor abnormalities, choking rescue, congenital malformations, developmental disorders or serious chronic disease patients;
- •Had a severe allergic reaction of vaccination in the past;
- •Took oral steroids more than 14 days in last month;
- •Had high fever (axillary temperature≥38.0℃ or higher)in the past three days;
- •Prepare to attend or is in any other drug clinical study;
- •Meningococcal vaccine contraindications and any situation which researchers think that may affect test evaluation.
结局指标
主要结局
systemic and local reactions 30 days after full-course vaccination
时间窗: 30 days
次要结局
未报告次要终点