A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of 15-Valent Pneumococcal Conjugate Vaccine in Healthy Volunteers Aged Above 2 Months
试验速览
- 阶段
- 1 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- SAE
研究概览
简要总结
The purpose of this study is to evaluate safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged above 3 Months.
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
- 6 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2 months old (at a minimum of 6 weeks old) and above healthy people.
- •Subject or legal representative who consent and has signed written informed consent.
- •Subject and parent/guardian who is able to comply with all study procedures and to use thermometer, scale and fill in diary card and contact card as required.
- •Subject who didn't vaccinate 13-valent or 7-valent pneumococcal conjugate vaccine.
- •Subject who did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
- •Axillary temperature ≤37.0 ℃.
排除标准
- •Subject with a history of a prior bacterial culture of an aggressive disease caused by S. pneumoniae.
- •Subject with any previous history of severe vaccination or drug allergy, occurrence of fever ≥ 39.0° related to vaccination of biological products for previous vaccination.
- •Subject who are allergic to diphtheria toxins.
- •Children below 1 year old with abnormal labor（dystocia, instrument midwifery), birth weight <2500g, asphyxia rescue history, nerve organ damage history, and pathological history of yellow plague determined by diagnosis.
- •History of allergy，eclampsia, epilepsy,brain trauma,encephalopathy and mental disease or family disease.
- •Subject who diagnosis of thrombocytopenia or other history of coagulopathy.
- •Known severe congenital malformations, developmental disorders; clinically diagnosed serious chronic diseases: down's syndrome, diabetes, sickle cell anemia or neurological disorders, Guillain Barre syndrome.
- •Known or suspected to suffer from: severe cardiovascular disease, liver and kidney disease, malignant tumor, skin disease, serious respiratory system disease, acute infection or chronic disease active period.
- •Known or suspected to suffer from immunological abnormalities, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroids, antimetabolic drugs, cytotoxicity drugs), HIV infection, etc.
- •Received blood products or immunoglobulin within 3 months before enrolling (hepatitis B immunoglobulin was acceptable), or planned to use it during the clinical trial period (before blood samples were collected after immunization).
- •Subject who plan to participate in or is in any other clinical trial (vaccines, drugs, medical devices, etc.).
- •In pregnancy or lactation or pregnant women.
- •≥18-year-old subject with blood routine, blood chemistry or urinalysis laboratory collection abnormalities.
- •Any condition that, in the judgment of investigator, may affect trial assessment.
研究组 & 干预措施
experimental group
Received Vaccine: 15-valent pneumococcal Conjugate Vaccine, 0.5 ml/dose
干预措施: 15-Valent Pneumococcal Conjugate Vaccine (Biological)
结局指标
主要结局
SAE
时间窗: from enrolling to 6 months after all vaccinations
Occurrence of serious adverse events (SAE) from enrolling to 6 months after all vaccinations
Urine routine of subjects over 18 years old at the fourth day
时间窗: 4 days after vaccination
Urine routine test results of subjects over 18 years old at the fourth day after vaccination
Blood routine of subjects over 18 years old at the fourth day
时间窗: 4 days after vaccination
Blood routine test results of subjects over 18 years old at the fourth day after vaccination
Adverse events in 30 minutes
时间窗: 30 minutes after each vaccination
Occurrence of adverse events in 30 minutes after each vaccination
Solicited adverse events during 7 days
时间窗: 7 days after each vaccination
Occurrence of solicited adverse events during a 7-day follow-up period after each vaccination
Unsolicited adverse events during 30 days
时间窗: 30 days after each vaccination
Occurrence of unsolicited adverse events during a 30-day follow-up period after each vaccination
Blood biochemistry of subjects over 18 years old at the fourth day
时间窗: 4 days after vaccination
Blood biochemistry test results of subjects over 18 years old at the fourth day after vaccination
次要结局
- Subjects ratio of vaccine serotype specific pneumococcal IgG antibody concentration ≥ 0.35 ug/ml or 1.0 ug/ml in 2-month-old and 3-month-old subjects(30 days after immunization)
- GMC of vaccine serotype specific pneumococcal IgG antibody in 2-month-old and 3-month-old subjects(30 days after immunization)