A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 717
- 试验地点
- 51
- 主要终点
- Percentage of Participants With Solicited Systemic AEs
研究概览
简要总结
This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.
详细描述
Participants will be randomized to 1 of 3 cohorts depending upon prior vaccinations. Prior vaccinations by cohort include: PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) for Cohort 1; PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) for Cohort 2; PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™), PCV20 (pneumococcal 20-valent conjugate vaccine; PREVNAR 20™), PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 for Cohort 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
- Double (Participant, Investigator)
盲法说明
Cohorts 1 and 2: participants, investigator, sponsor Cohort 3: no blinding
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has received pneumococcal vaccine >= 1 year before enrollment (PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23).
排除标准
- •Has a history of invasive pneumococcal disease (IPD).
- •Has a known hypersensitivity to any component of V116, PCV15, PCV20, or PPSV23, including diphtheria toxoid.
- •Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease.
- •Has a coagulation disorder contraindicating intramuscular vaccination.
- •Has a known malignancy that is progressing or has required active treatment.
- •Has received PPSV23 followed by either PCV15 or PCV
- •Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day).
- •Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease.
- •Has received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of any study vaccine.
- •Has received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine.
- •Has received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 post-vaccination blood draw is complete.
研究组 & 干预措施
Cohort 1: V116
Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
干预措施: V116 (Biological)
Cohort 1: PCV15
Participants will receive a single 0.5 mL IM injection of PCV15 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
干预措施: PCV15 (Biological)
Cohort 2: V116
Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
干预措施: V116 (Biological)
Cohort 2: PPSV23
Participants will receive a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
干预措施: PPSV23 (Biological)
Cohort 3: V116
Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV20, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
干预措施: V116 (Biological)
结局指标
主要结局
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 patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any of the injections with either V116, PCV15, or PPSV23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
时间窗: 30 Days post-vaccination
OPA for the serotypes contained in V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented.
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
时间窗: Up to 5 days post-vaccination
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any injection with either V116, PCV15, or PPSV23 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were erythema, pain, and swelling.
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
时间窗: Up to ~180 days
A serious adverse event (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. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination are presented.
次要结局
- Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)(30 Days post-vaccination)
- Geometric Mean Fold Rise of Serotype-specific IgG(Day 1 (Baseline) and 30 days post-vaccination)
- Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)(Day 1 (Baseline) and 30 days post-vaccination)
- Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses(Day 1 (Baseline) and 30 days post-vaccination)
- Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response(Day 1 (Baseline) and 30 days post-vaccination)