NCT02869672Unknown3 期
Safety and Immunogenicity Study of ACYW135 Meningococcal Polysaccharide Vaccine Aged 2-50 Years Old
Beijing Chaoyang District Centre for Disease Control and Prevention0 个研究点目标入组 1,200 人开始时间: 2016年7月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 1,200
- 主要终点
- Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people.
研究概览
简要总结
This study evaluates the safety and immunogenicity of the ACYW135 Meningococcal Polysaccharide Vaccine in population aged 2-50 years old. Subjects will be divided into 3 group according to their age, receiving the test vaccine and the control vaccine at the proportion of 1:1 randomly. Each age group has 400 subjects, 1200 in total.
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 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •With the subject (or his guardian's) informed consent and signed the informed consent;
- •The history, physical examination and clinical judgement were determined to be healthy and in accordance with the vaccination age of the product;
- •The Subject or his guardian could comply with the clinical study protocol;
- •Have not been inoculated with Meningococcal vaccine in the past six months and A + C meningococcal polysaccharide vaccine in the past two years;
- •Have not been inoculated with other preventive biological products;
- •Axillary temperature≤37.0 ℃.
排除标准
- •Children with the history of Neisseria meningitis;
- •Had allergies or serious adverse reactions of previous vaccination, such as allergies, urticaria, dyspnea, edema, abdominal pain, etc;
- •Had immune inhibitor therapy and cytotoxic therapy, inhaled corticosteroids in the past 6 months (not including allergic rhinitis corticosteroid aerosol therapy, patients with acute non concurrent dermatitis surface corticosteroid therapy);
- •Have been accepted blood products in the past 3 months;
- •Have been inoculated with other research drugs or vaccines in the past month;
- •Have been inoculated with attenuated live vaccine in the past 14 days;
- •Have been inoculated with subunit or inactivated vaccine in the past 7 days;
- •Had any acute illness, the need for systemic application of antibiotics or antiviral treatment in the past 7 days;
- •Had fever in the past 3 days (axillary temperature≥38.0℃) ;
- •Have been diagnosed with abnormal coagulation function (such as the lack of coagulation factors, coagulation disorders and abnormal blood platelet), obvious bruises or coagulation disorders by physician diagnosis;
- •Had the history of thyroid resection or the need for treatment of thyroid diseases in the past 12 months;
- •Asplenia, functional asplenia and asplenia or splenectomy of any situation;
- •Had epilepsy, convulsions, encephalopathy, mental illness or family history;
- •Suffering from serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia, neurological disorders or Guillain-Barre syndrome);
- •Suffering from known or suspected concurrent diseases including: respiratory diseases, acute or chronic infection of the activities, children's mother or the subject had HIV infection, cardiovascular disease, high blood pressure, during cancer treatment period, skin diseases;
- •The female during her pregnant and lactation period or who plan to become pregnant during the trial.
- •The subject of any other factors that are not suitable to participate in clinical trials according to the researcher's judgment.
结局指标
主要结局
Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people.
时间窗: 28 days
The serum antibody titers will be evaluated at 28 days after vaccination.
Evaluate the Rate of Adverse reactions of quadrivalent influenza Vaccine in healthy people.
时间窗: 28 days
Adverse reactions associated with vaccine will be observed in subjects after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy.
次要结局
未报告次要终点
研究者
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