A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 694
- 试验地点
- 90
- 主要终点
- Percentage of Participants With Vaccine-Related Serious Adverse Events
研究概览
简要总结
The purpose of this clinical study is to evaluate the safety and immunogenicity of a 4-dose schedule (3-dose primary series followed by a toddler dose) of V114 compared with Pneumococcal 13-valent Conjugate Vaccine (PCV13). The hypotheses are that: 1) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on the response rates at 30 days following dose 3; 2) V114 is non-inferior to PCV13 for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes at 30 days following dose 3; 3) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following dose 3.
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
- 2 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Japanese male or female
排除标准
- •Has a history of invasive pneumococcal disease (IPD)
- •Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid containing vaccine
- •Has a known or suspected impairment of immunological function
- •Has a history of congenital or acquired immunodeficiency
- •Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
- •Has or his/her mother has a documented hepatitis B surface antigen-positive test
- •Has known or history of functional or anatomic asplenia
- •Has a history of autoimmune disease
- •Has a known neurologic or cognitive behavioral disorder
- •Has received a dose of any pneumococcal vaccine prior to study entry
- •Has received a blood transfusion or blood products, including immunoglobulins
结局指标
主要结局
Percentage of Participants With Vaccine-Related Serious Adverse Events
时间窗: ~1 month after Dose 4, up to a total of 14 months
A serious adverse event (SAE) is an AE that 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. The percentage of participants with a vaccine-related SAE following dose 1 (with either V114 or PCV13) was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 through completion of study.
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3
时间窗: 30 Days after Dose 3, up to a total of 11 months
The anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin G (IgG) response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay.
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3
时间窗: 30 Days after Dose 3, up to a total of 11 months
The anti-PnPs serotype-specific IgG Geometric Mean Concentrations (GMCs) of participants administered V114 versus participants administered PCV13 for the 13 serotypes shared in V114 and PCV13 were determined using an electrochemiluminescence assay.
Percentage of Participants With Solicited Injection-Site Adverse Events
时间窗: Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any injection with either V114 or PCV13 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, induration, pain, and swelling.
Percentage of Participants With Solicited Systemic Adverse Events
时间窗: Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the injections with either V114 or PCV13, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were decreased appetite, irritability, somnolence, and urticaria.
次要结局
- GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4(30 Days after Dose 4, up to a total of 14 months)
- GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4(30 Days after Dose 4, up to a total of 14 months)
- GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3(30 days after Dose 3, up to a total of 11 months)
- Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4(30 Days after Dose 4, up to a total of 14 months)
- Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3(30 Days after Dose 3, up to a total of 11 months)