NCT01661725已完成1 期
Phase I Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Safety
研究概览
简要总结
The clinical trial was designed to evaluate the safety 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 I clinical trial of Group ACYW135 Meningococcal Polysaccharide Vaccine. The safety end points were the presence of any systemic, local and adverse reaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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: Day 28 after vaccination
All systemic and local adverse reactions and related adverse events on day 28 after the vaccination
次要结局
未报告次要终点
研究者
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