A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Japanese Adults 65 Years of Age or Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 8
- 主要终点
- Percentage of Participants With Solicited Systemic AEs
研究概览
简要总结
This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve Japanese adults 65 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23 and the cross-reactive serotype 15B in V116, and that the immunogenicity of V116 is superior to PPSV23 for the unique serotype 15C in V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in the 8 unique V116 serotypes (except for 15C), as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).
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)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is Japanese
- •For females, is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) or is a POCBP and uses acceptable contraception/abstinence; has a negative highly sensitive pregnancy test (urine or serum) within 24 (urine) or 72 (serum) hours before the first dose of study intervention; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of inclusion of an early undetected pregnancy
排除标准
- •Has a history of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site] or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1)
- •Has a known hypersensitivity to any component of V116 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 IM vaccination
- •Had a recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring <72 hours before receipt of study vaccine
- •Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
- •Received prior pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol
- •Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention ≥14 days before receipt of study vaccine
- •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
- •Received any nonlive vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine ≤30 days after receipt of study vaccine (inactivated influenza and SARS-CoV2 vaccines may be acceptable)
- •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
- •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 postvaccination blood draw is complete
研究组 & 干预措施
V116
Participants receive a single intramuscular (IM) injection of V116 on Day 1.
干预措施: V116 (Biological)
PPSV23
Participants receive a single IM injection of PPSV23 on Day 1.
干预措施: PPSV23 (Biological)
结局指标
主要结局
Percentage of Participants With Solicited Systemic AEs
时间窗: Up to 5 days postvaccination
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. The solicited systemic AEs were muscle pain/myalgia, headache, and tiredness/fatigue.
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
时间窗: Up to 5 days postvaccination
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. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.
Percentage of Participants With Vaccine-related Serious AEs (SAEs)
时间窗: Up to 30 days postvaccination
An SAE is any untoward medical occurrence that 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. SAEs that were reported to be at least possibly related by the investigator to study vaccination were summarized.
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
时间窗: Day 30 postvaccination
The serotype-specific OPA GMTs for the 12 common serotypes contained in V116 and PPSV23, the unique serotype 15C in V116, and the cross-reactive serotype 15B were determined using the multiplex opsonophagocytic assay (MOPA).
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116)
时间窗: Baseline (Day 1) and Day 30 postvaccination
The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs for the 8 unique serotypes contained in V116 (except for 15C) were determined.
次要结局
- Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT(Baseline (Day 1) and Day 30 postvaccination)
- Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)(Day 30 postvaccination)
- Serotype-specific OPA GMTs (Unique Serotypes)(Day 30 postvaccination)
- Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)(Baseline (Day 1) and Day 30 postvaccination)
- Serotype-specific GMFR in IgG GMCs(Baseline (Day 1) and Day 30 postvaccination)
- Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)(Baseline (Day 1) and Day 30 postvaccination)