NCT05252715Unknown3 期
A Single-center, Randomized, Blind, Positive Control Phase III Clinical Trial to Evaluate Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged From 3 to 5 Months
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Immunogenicity study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine as assessed by positive conversion rate
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 to 5 months.
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 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For primary vaccination
- •Subjects aged 3-5 months;
- •Subjects should be full-term (37-42 weeks of gestation) and their birth weight should meet the requirements (2500g ≤ body weight ≤ 4000g);
- •Axillary body temperature ≤ 37.0 ℃;
- •The guardian signs the informed consent form;
- •The guardian and his family agree to comply with the requirements of the clinical trial protocol;
- •Subjects who have not been vaccinated with meningococcal group A and C conjugate vaccine at the aged of 3-5 months;
- •Subjects who had no history of other live vaccines within 14 days before vaccination and no history of other inactivated vaccines within 7 days;
- •For booster vaccination
- •Infants in the experimental group who have completed primary immunization in this clinical trial and reach the age of 18 months;
- •The guardian and his family agree to comply with the requirements of the clinical trial protocol.
排除标准
- •For primary vaccination
- •Test-tube baby who is suffering from perianal abscess, severe eczema or pathological jaundice;
- •History of severe allergic reactions requiring medical intervention (such as swelling of mouth and throat, dyspnea, hypotension or shock);
- •A clearly diagnosed history of thrombocytopenia or other coagulation disorders that may cause contraindications to intramuscular injection;
- •History of Abnormal production process, asphyxia rescue, or congenital malformation, serious developmental disorder, serious genetic defect, serious malnutrition or serious chronic disease;
- •Have been diagnosed as infectious diseases, such as tuberculosis, viral hepatitis or their parents infected with human immunodeficiency virus (HIV);
- •Have progressive nervous system diseases such as encephalopathy, epilepsy, convulsions or related family history;
- •History of acute disease, severe chronic disease, acute attack of chronic disease and fever (axillary body temperature ≥ 38.0 ℃) or take antipyretic, analgesic and antiallergic drugs (such as acetaminophen, ibuprofen, aspirin, etc.) in the past 3 days;
- •History of using illegal drugs (receiving systemic corticosteroid treatment≥2mg/kg/day through any route of administration, and using ≥14 days, such as prednisone, inhaled hormone budesonide, fluticasone, etc., or receiving other immunosuppressants, such as cyclophosphamide, etc.);
- •History of using immunoglobulins and / or any blood products (except hepatitis B immunoglobulin) within 3 months before enrollment;
- •Plan to participate or be participating in any other drug clinical research;
- •According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.
- •For booster vaccination
- •The subjects were vaccinated with any meningococcal vaccine after primary immunization and before blood collection of booster immunization;
- •The subjects have been known or suspected to have immunological defects since participating in this clinical trial, including being treated with immunosuppressants (such as chemotherapy, corticosteroids, antimetabolics, cytotoxic drugs, etc.) and HIV infection;
- •History of using immunoglobulins and / or any blood products (except hepatitis B immunoglobulin) within 3 months before booster immunization;
- •According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.
研究组 & 干预措施
Meningococcal ACYW135 Polysaccharide Conjugate Vaccine
Experimental
Meningococcal ACYW135 Polysaccharide Conjugate Vaccine, 20 µg/dose. Primary vaccination at 0, 1 and 2 months of age, respectively. Booster vaccination at 18 months of age.
干预措施: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine (Biological)
Meningococcal A and C Polysaccharide Conjugate Vaccine
Active Comparator
Meningococcal A and C Polysaccharide Conjugate Vaccine, 20 µg/dose. Primary vaccination at 0, 1 and 2 months of age, respectively.
干预措施: Meningococcal A and C Polysaccharide Conjugate Vaccine (Biological)
结局指标
主要结局
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 (2)
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