Safety and Immunogenicity of 23-valent Pneumococcal Polysaccharide Vaccine in 2 to 70 Years Old Healthy People in China
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- To evaluate the immunogenicity of 23-valent Pneumococcal Polysaccharide Vaccine after vaccination
研究概览
简要总结
Pneumococcal infection is a leading cause of death throughout the world and a major cause of pneumonia, bacteremia, meningitis, and otitis media.
It has been established that purified pneumococcal capsular polysaccharides induce antibody production and such antibody is effective in preventing pneumococcal disease. Clinical studies have demonstrated the immunogenicity of each of the 23 capsular types when tested in polyvalent vaccines. Studies of 23-valent pneumococcal vaccine in children of two years old and older and in adults of all ages have showed immunogenic response. In order to provide more evidence for the immunogenicity and the safety of the vaccine, a phase III clinical trial is planed to conduct.
详细描述
Pneumonia is a major cause of morbidity and mortality in developing countries. Pneumonia is predominantly bacterial in origin: isolation rates of Streptococcus pneumoniae and Haemophilus influenzae were 34% and 40%, respectively, in a series of lung aspirates collected from children under 5 years of age (Shann et al., 1984).
Pneumococcal infection is a leading cause of death throughout the world and a major cause of pneumonia, bacteremia, meningitis, and otitis media.
Strains of drug-resistant S. pneumoniae have become increasingly common in China and in other parts of the world. In some areas as many as 35% of pneumococcal isolates have been reported to be resistant to penicillin. Many penicillin-resistant pneumococci are also resistant to other antimicrobial drugs (e.g., erythromycin, trimethoprim-sulfamethoxazole and extended-spectrum cephalosporins), therefore the importance of vaccine prophylaxis should be emphasized against pneumococcal disease.
Epidemiology Pneumococcal infection causes approximately125,000 deaths annually in China. At least 2,500,000 cases of pneumococcal pneumonia are estimated to occur annually in the United States; S. pneumoniae accounts for approximately 25-35% of cases of community-acquired bacterial pneumonia in persons who require hospitalization.
Despite appropriate antimicrobial therapy and intensive medical care, the overall case-fatality rate for pneumococcal bacteremia is 15-20% among adults, and among elderly patients this rate is approximately 30-40%. An overall case-fatality rate of 36% was documented for adult inner-city residents who were hospitalized for pneumococcal bacteremia.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 2 to 70 years on the day of inclusion
- •Informed consent form signed by subjects and parent/guardian
- •Subjects and parents/guardians able to attend all scheduled visits and comply with all study procedures
排除标准
- •Subjects with any pneumococcal vaccine before vaccination
- •History of pneumococcal infection
- •Women in pregnancy or lactation period in trial period
- •Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia
- •Known or suspected immune dysfunction, including persons with congenital immunodeficiency or persons with HIV positive.
- •Functional or anatomic asplenia
- •Patients treated with chemotherapy in past 5 years or 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 30 days preceding vaccination
- •Receipt of any subunit vaccine and inactivated vaccine in the 14 days before vaccination
- •Thrombocytopenia, bleeding disorder
- •History of asthma，angioneurotic edema，diabetes mellitus or malignancy tumor
- •History of thyroid gland excision or treatment for thyroid gland disease in last 12 months
- •Hypertension, blood pressure still above 145/95mmHg even with drug treatment
- •History of eclampsia, epilepsia, psychosis
- •Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination
- •In progress of anti-tuberculosis prophylaxis or therapy
- •Those can not fulfill the protocol or can not sign the informed consent form for any medical, psychological, social, occupational and other reasons, according to investigator judgment
结局指标
主要结局
To evaluate the immunogenicity of 23-valent Pneumococcal Polysaccharide Vaccine after vaccination
时间窗: 28 days after vaccination
To evaluate the percentage of subjects exhibiting a ≥ 2 fold increase in IGG antibody level after vaccination
次要结局
- To evaluate the safety of 23-valent Pneumococcal Polysaccharide Vaccine after vaccination(28 days after vaccination)