NCT01661751已完成3 期
Phase III Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 900
- 主要终点
- Safety
研究概览
简要总结
The clinical trial was designed to evaluate the safety and immunogenicity against Group ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of age and older.
详细描述
Complying with requirements of the approval letter of clinical trial issued by SFDA (Approval Letter No.: 2006L01017), Hualan conducted phase III clinical trial of Group ACYW135 Meningococcal Polysaccharide Vaccine to evaluate the safety and immunogenicity of the experimental vaccine.
The safety end points were the presence of any systemic, local and adverse reaction. Evaluation indicators of immunogenicity were bacteriocin levels of groups A, C, Y and W135 respectively in the serum after the whole vaccination.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy permanent residence 2 years of age and older, the subjects (or their guardians) are able to understand and sign the informed consent;
- •Healthy male or female by oral history, physical examination and clinical judgment and who complies with vaccination of this product;
- •Be able to comply with the requirements of clinical trial protocol and immunogenicity examination;
- •Have no history of vaccination within the past 3 months and vaccination with other products within the last 2 weeks;
- •Axillary temperature ≤37.0℃.
排除标准
- •Any acute disease, such as: tumor, autoimmunity disease, progressive atherosclerotic disease or diabetes with complication, chronic obstructive pulmonary disease need oxygen uptake, acute or progressive hepatopathy or nephropathy, congestive heart-failure, etc.;
- •Allergic to vaccines or drugs (history of allergy to any vaccine in the past);
- •History of neurologic symptom or signs;
- •Known or suspected (or high risk) impaired or abnormal immune function, e.g.: receive immunosuppressant or immunopotentiator therapy, take immunoglobulin or blood product or plasma extract (except the gastrointestinal tract) within the past 3 months, HIV infection or related disease, etc.;
- •History of meningitis infection or vaccination of meningococcal vaccine within the past 3 months;
- •History of receiving other vaccines or immunoglobulin injection or any research drugs;
- •Any acute disease needing application of antibiotics or anti-virus treatment in the whole body within the past 1 week;
- •History of fever within the past 3 days (axillary temperature ≥38.0℃);
- •Participating in another clinical trial;
- •History of allergy, eclampsia, epilepsy, encephalopathy and mental disease or family disease;
- •Thrombopenia or other coagulopathy that may cause contraindication to intramuscular injection;
- •Acute 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, SBAV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc.;
- •Pregnancy
- •Any condition that, in the judgment of investigator, may affect trial assessment.
结局指标
主要结局
Safety
时间窗: Dat 28 after vaccination
Systemic and local adverse reactions after the vaccination; adverse events
次要结局
- Immunogenicity(The 4th week after immunization)
研究者
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