Phase I Clinical Trial to Evaluate the Safety and Explore the Immunogenicity of a Candidate PCV13 in Healthy People Aged 2 Months (Minimum 6 Weeks) and Above
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Safety in terms of SAEs
研究概览
简要总结
Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year. Since the licensure of PCV7, PCV10, PCV13 and PCV15, the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years is approximately 60% around the world.
This is a single center, blinded, randomized, positive-controlled phase I clinical trial to evaluate the safety and explore the immunogenicity of a candidate PCV13 in healthy people aged 2 months (minimum 6 weeks) and above.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
One arm, open label in subjects aged 3 months and above; Randomized, blinded and active comparator in subjects aged 2 months.
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
- •Satisfy the age requirements of the clinical trial; willing to provide proof of identity;
- •Subjects or guardians must provide informed consent forms with personal signature and date;
- •Male and female of childbearing age should agree to take effective contraception measures;
- •Subjects or guardians can obey the requirements of the clinical study;
- •Axillary temperature below 37.3 °C.
排除标准
- •Laboratory indicators (expect those have no clinical significance) out of normal ranges required;
- •Received any pneumococcal vaccine;
- •Allergic history to any drugs, vaccine or vaccine-related component;
- •Infants with congenital malformations, developmental disorders, genetic defects, or severe malnutrition;
- •Infants diagnosed with pathological jaundice that lasts for 2~4 weeks and occurs repeatedly;
- •Breast-feeding or pregnant women, or positive U-HCG;
- •High blood pressure uncontrolled by medication;
- •Known or suspected immune deficiency or immune suppression;
- •Serious congenital malformation, history of organ resection or serious chronic illness;
- •Received blood products or intravenous immunoglobulin (except Hepatitis B immunoglobulin);
- •History of clinic-proven or serology-proven infectious disease especially caused by streptococcus pneumoniae;
- •History of convulsions, epilepsy or encephalopathy or a family history of mental illness;
- •A vaccination-related contraindications that other investigator believes;
- •Plans to participate in or is participating in any other clinical study;
- •Any other factors judged by investigator that may interfere subject's compliance with the protocol.
结局指标
主要结局
Safety in terms of SAEs
时间窗: within 6 months post last vaccination
Occurrence of SAEs of each subject
Safety in terms of adverse events
时间窗: within 30 days post each vaccination
Occurrence of non-solicited AEs of each subject
Safety in terms of laboratory-based AEs
时间窗: within 4 days post each vaccination
Occurrence of laboratory-based AEs in subjects of 2 years old and above(Arm 1A-3A)
Safety in terms of adverse reactions
时间窗: within 30 minutes post each vaccination
Occurrence of AEs on vaccination site (local) and non-vaccination site (systemic) of each subject
次要结局
- Immunogencity Comparison with control vaccine group(30 days post basic vaccination)
- Immunogencity in terms of subjects with IgG concentrations ≥1.0 µg/mL(30 days post basic vaccination)
- Immunogencity in terms of seropositivity rates by ELISA(30 days post basic vaccination)
- Immunogencity in terms of GMC by ELISA(30 days post basic vaccination)