A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Adults 65 Years of Age or Older Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 253
- 主要终点
- Percentage of Participants With a Solicited Systemic Adverse Event (AE)
研究概览
简要总结
This study is designed to assess the safety, tolerability, and immunogenicity of V114 compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.
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 in good health (any underlying chronic illness must be documented to be in stable condition)
- •Has documented proof of receipt of 23-valent pneumococcal polysaccharide vaccine ≥1 year prior to study entry
- •Is a male or postmenopausal female
排除标准
- •Has received prior administration of any pneumococcal vaccine other than 23-valent pneumococcal polysaccharide vaccine
- •Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
- •Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine
- •Is known or suspected impairment of immune function
- •Has received systemic corticosteroids for >=14 consecutive days and has not completed treatment <=30 days prior to study entry, or received systemic corticosteroids exceeding physiologic replacement doses within 14 days prior to study vaccination
- •Has a coagulation disorder contraindicating intramuscular vaccination
- •Receives immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease
- •Has received a blood transfusion or blood products, including immunoglobulins within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion
- •Has participated in another clinical study of an investigational product within 2 months before the beginning of or any time during the duration of the current clinical study
- •Is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.
结局指标
主要结局
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
时间窗: Up to Day 14 after vaccination
Solicited systemic AEs consisted of fatigue, arthralgia, myalgia, and headache.
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
时间窗: Baseline (Day 1) and Day 30 after vaccination
The GMFR (Day 30 geometric mean concentration \[GMC\] / Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence.
Percentage of Participants With an Adverse Event (AE)
时间窗: Up to Day 44 after vaccination
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
时间窗: Up to Day 5 after vaccination
Solicited injection-site AEs consisted of erythema/redness, swelling, and pain/tenderness.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
时间窗: Baseline (Day 1) and Day 30 after vaccination
The IgG GMCs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Concentrations were determined using pneumococcal electrochemiluminescence.
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
时间窗: Baseline (Day 1) and Day 30 after vaccination
The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMCs of each pneumococcal serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence.
次要结局
- Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)(Baseline (Day 1) and Day 30 after vaccination)
- Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)(Baseline (Day 1) and Day 30 after vaccination)
- Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)(Baseline (Day 1) and Day 30 after vaccination)