A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Children and Adolescents With Increased Risk of Pneumococcal Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 882
- 试验地点
- 92
- 主要终点
- Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children and teenagers 2 through 17 years of age, who had completed routine pneumococcal vaccine as infants/toddlers. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting pneumococcal disease (PD).
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 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a diagnosis and stable medical management (for at least 3 months) of one of the following risk conditions for pneumococcal disease: Diabetes mellitus, chronic compensated liver disease, chronic lung disease, chronic heart disease, or chronic kidney disease.
- •Has completed pneumococcal conjugate vaccine regimen (PCV7, PCV10, or PCV13) at least 8 weeks before study enrollment.
排除标准
- •Had a curative procedure/surgery for chronic heart disease and does not require medication, follow-up, additional interventions, or further management per local guidelines.
- •Has a history of active hepatitis within 3 months before study vaccination.
- •Has a history of diabetic ketoacidosis or 2 or more episodes of severe, symptomatic hypoglycemia within 3 months before study vaccination.
- •Has a history of severely decreased kidney function dialysis, autoimmune related chronic kidney disease, nephrotic syndrome of any cause, or an acute/reversible cause of kidney disease.
- •Has a history of severe pulmonary hypertension or history of Eisenmenger syndrome.
- •History of invasive pneumococcal disease within 3 years before study vaccination.
研究组 & 干预措施
V116
Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1
干预措施: V116 (Biological)
PPSV23
Participants will receive a single 0.5 mL IM dose of PPSV23 on Day 1.
干预措施: PPSV23 (Biological)
结局指标
主要结局
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses
时间窗: 30 days postvaccination
Opsonophagocytic activity (OPA) for the serotypes in V116 will be determined using a multiplexed opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
时间窗: Up to 5 days postvaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included pain/tenderness, redness/erythema, and swelling.
Percentage of Participants With Solicited Systemic AEs
时间窗: Up to 5 days post vaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included muscle aches all over the body (myalgia), headache, tiredness (fatigue), hives or welts (urticaria), irritability, joint pain (arthralgia), drowsiness (somnolence), feeling sick (malaise), and fever (pyrexia).
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
时间窗: Up to approximately 6 months
A vaccine-related SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event.
次要结局
- Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination(30 days postvaccination)
- Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs(Baseline (Day 1) and 30 days postvaccination)
- Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs(Baseline (Day 1) and Day 30 postvaccination)
- GMFR From Baseline in Serotype-specific IgG GMCs(Baseline (Day 1) and Day 30 postvaccination)
- Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs(Baseline (Day 1) and Day 30 postvaccination)