A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of Pneumococcal Conjugate Vaccine (V114) Compared to Prevnar™ in Healthy Adults and Toddlers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Adult: Percentage of Participants With Any Adverse Event
研究概览
简要总结
This study is being conducted to evaluate the safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine (V114) compared to Prevnar™ in healthy adults and toddlers.
详细描述
The study was extended to obtain additional sera from adult participants to support further development, validation, and performance of anti-pneumococcal antibody assays.
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
- 12 Months 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Adult: Percentage of Participants With Any Adverse Event
时间窗: Up to Day 14 after vaccination
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Toddler: Percentage of Participants With Any Serious Adverse Event
时间窗: Up to Day 14 after vaccination
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.
Toddler: Percentage of Participants With Any Adverse Event
时间窗: Up to Day 14 after vaccination
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Adult: Percentage of Participants With Any Vaccine-related Adverse Event
时间窗: Up to Day 14 after vaccination
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Relatedness of the AE to study vaccine was determined by the investigator.
Toddler: Percentage of Participants With Any Vaccine-related Adverse Event
时间窗: Up to Day 14 after vaccination
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Relatedness of the AE to study vaccine was determined by the investigator.
Adult: Percentage of Participants With Any Serious Adverse Event
时间窗: Up to Day 14 after vaccination
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.
次要结局
- Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL(Day 30 after vaccination)
- Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies(Day 30 after vaccination)
- Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL(Day 30 after vaccination)
- Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA)(Day 30 after vaccination)
- Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies(Day 30 after vaccination)
- Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8(Day 30 after vaccination)
- Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8(Day 30 after vaccination)
- Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA)(Day 30 after vaccination)