A Study on the Immunization Schedule for the 13-Valent Pneumococcal Polysaccharide-Conjugate Vaccine in Healthy Infants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 主要终点
- Seropositivity rate 30 days after the booster dose
研究概览
简要总结
To compare the immunogenicity of the domestically produced PCV13 vaccine in healthy 2-month-old infants following administration via the 2+1 and 3+1 schedules, with the primary endpoint being the seroprevalence of specific IgG antibodies after completion of the vaccination series.To evaluate the safety of the 2+1 schedule in infants and young children (incidence of adverse events and serious adverse events).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Days 至 89 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1: Age at enrollment: 2 months (60-89 days)
- •2: A healthy male or female infant, born at term (≥37 weeks' gestation), with a birth weight of ≥2500 g
- •3: Parents/guardians must provide written informed consent, and participants must be capable of using a thermometer and a ruler and of completing the daily log card as instructed
- •4: Able to adhere to study protocols, including completing all visits and blood collections
排除标准
- •received any pneumococcal vaccine before enrollment or schedule to receive a non-study pneumococcal vaccine during the study
- •A history of culture-confirmed invasive disease caused by Streptococcus pneumoniae
- •Known allergy to vaccine components, including excipients, diphtheria toxoid, tetanus toxoid, etc.
- •Acute illness at enrollment or axillary temperature >37°C
- •Immune deficiency, chronic illness, or use of immunosuppressive therapy
- •Patients with thrombocytopenia, any coagulation disorder, or those receiving anticoagulant therapy
- •Participation in another clinical trial within the past 30 days or during this study
- •Has received another live attenuated vaccine within the past 14 days, or another inactivated vaccine within the past 7 days
- •Has received immunoglobulin within the past month
- •Any circumstances that researchers believe may affect the evaluation of the study
研究组 & 干预措施
A
2, 4, and 12 months vaccination schedule
干预措施: the domestically produced 13-valent Pneumococcal Polysaccharide Conjugate vaccine (Drug)
B
2, 4, 6 and 12 months vaccination schedule
干预措施: the domestically produced 13-valent Pneumococcal Polysaccharide Conjugate vaccine (Drug)
结局指标
主要结局
Seropositivity rate 30 days after the booster dose
时间窗: 30 days after the booster dose
次要结局
未报告次要终点