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
- Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
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.
研究组 & 干预措施
Prevnar 13™
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine will receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
干预措施: Prevnar 13™ (Biological)
V114
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine will receive a single 0.5 mL intramuscular injection of V114 on Day 1.
干预措施: V114 (Biological)
结局指标
主要结局
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 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.
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)