NCT02003495已完成3 期
Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine in Healthy Subjects 2 Months to 6 Years of Age in China
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,195
- 试验地点
- 1
- 主要终点
- Percentage of subjects exhibiting a >= 4fold increase in rSBA titers level from pre-vaccination to post-vaccination
研究概览
简要总结
The purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of Meninggococcal (A,C,Y and W135) Conjugate Vaccine in 2 months to 6 years-old children.
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
- 2 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
- •Healthy permanent residence 2 months to 6 years old.
- •Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures.
- •Axillary temperature ≤37.0 ℃.
排除标准
- •History of meningitis infection or vaccination of meningococcal vaccine within the past 6 months.
- •Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia.
- •Patients administered with immunosuppressive agents, cytotoxicity factor or corticosteroids in the 6 months preceding the vaccine trial.
- •Receipt of blood or blood-derived products in the 3 months preceding vaccination
- •Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination.
- •Receipt of any live virus vaccine in the 15 days preceding vaccination.
- •Receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination.
- •Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination.
- •Thrombocytopenia.
- •History of thyroid gland excision or treatment for thyroid gland disease in last 12 months.
- •Functional or anatomic asplenia.
- •History of eclampsia, epilepsy, encephalopathy and mental disease or family disease.
- •Chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, Guillain-Barre Syndrome).
- •Known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, HIV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc.
- •Any condition that, in the judgment of investigator, may affect trial assessment.
结局指标
主要结局
Percentage of subjects exhibiting a >= 4fold increase in rSBA titers level from pre-vaccination to post-vaccination
时间窗: 28 days after vaccination
次要结局
- to evaluate the adverse reactions after vaccination(Within 28 days after vaccination)
研究者
研究点 (1)
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