A Study of V114 and Acute Otitis Media in Children (PNEU-ERA)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 7,119
- 试验地点
- 24
- 主要终点
- Percentage of Participants with Serious Adverse Events
研究概览
简要总结
The primary objective is to evaluate V114 in the prevention of vaccine-type acute otitis media (VT-AOM) and the safety of V114 with respect to the proportion of participants with serious adverse events (SAEs) through completion of the study. The primary hypothesis is that V114 is superior to no V114 in preventing VT-AOM as assessed by the incidence of VT-AOM.
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
- 42 Days 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is healthy (based on a review of medical history and physical examination)
- •Is male or female, approximately 2 months of age, from 42 days to 90 days of age
排除标准
- •Was born prior to 37 weeks of gestation.
- •Has a history of invasive pneumococcal disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
- •Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine.
- •Has any contraindication to the concomitant study vaccines being administered in the study.
- •Has external auditory canal atresia/stenosis.
- •Has a known or suspected impairment of immunological function.
研究组 & 干预措施
V114
Participants will receive an intramuscular (IM) injection.
干预措施: V114 (Biological)
V114
Participants will receive an intramuscular (IM) injection.
干预措施: Pediatric vaccines (Other)
Control
干预措施: Pediatric vaccines (Other)
结局指标
主要结局
Percentage of Participants with Serious Adverse Events
时间窗: Up to ~36 months
A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
Number of Participants with a First Episode of Vaccine-Type Acute Otitis Media (VT-AOM) Caused by the Pneumococcal Serotypes Contained in V114
时间窗: Up to ~36 months
The number of participants with VT-AOM will be presented.
Percentage of Participants with Vaccine-Related Serious Adverse Events
时间窗: Up to ~36 months
A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
Percentage of Participants Who Discontinued the Study due to Serious Adverse Events
时间窗: Up to ~36 months
A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
Percentage of Participants Who Died
时间窗: Up to ~36 months
The percentage of participants who died from any cause during the study will be assessed.
次要结局
未报告次要终点