A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Pneumococcal Vaccine-Naïve Adults 50 Years of Age or Older
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 690
- 主要终点
- Percentage of Participants With a Solicited Systemic Adverse Event (AE)
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, and immunogenicity of a single dose of different formulations of V114 (V114-A and V114-B) and Prevnar 13® (pneumococcal 13-valent conjugate vaccine) in adult participants
≥50 years of age in good health.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good health; any underlying chronic illness must be documented to be in stable condition
- •Highly unlikely to conceive through 6 weeks after administration of the study vaccine
排除标准
- •Prior administration of any pneumococcal vaccine
- •History of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture-positive pneumococcal disease
- •Known hypersensitivity to any vaccine component
- •Known or suspected impairment of immune function
- •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
- •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
- •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.
- •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
- •Breast feeding
- •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
V114 Formulation A
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1
干预措施: V114-A (Biological)
V114 Formulation B
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1
干预措施: V114-B (Biological)
Prevnar 13®
Participants receive a single 0.5 mL intramuscular injection of Prevnar 13® on Day 1
干预措施: Prevnar 13® (Biological)
结局指标
主要结局
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
时间窗: Up to 14 days after vaccination
The percentage of participants experiencing ≥1 solicited systemic AE(s) in each arm was determined.
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
时间窗: Up to 14 days after vaccination
The percentage of participants experiencing ≥1 solicited injection-site AE(s) in each arm was determined.
Percentage of Participants With an Adverse Event (AE)
时间窗: Up to 14 days after vaccination
The percentage of participants experiencing ≥1 AE(s) in each arm was determined. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Percentage of Participants With a Serious Adverse Event (SAE)
时间窗: Up to 30 days after vaccination
The percentage of participants experiencing ≥1 SAE(s) in each arm was determined.
Percentage of Participants With Vaccine-Related Serious Adverse Event (SAE)
时间窗: Up to 30 days after vaccination
The percentage of participants experiencing ≥1 vaccine-related SAEs(s) in each arm was determined.
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
时间窗: Day 30 (one month after vaccination)
The OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were determined in each arm. Titer levels were determined with the multiplexed opsonophagocytic assay (MOPA).
次要结局
- Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination(Day 30 (one month after vaccination))
- Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)(Baseline and Day 30 (one month after vaccination))
- Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies(Baseline and Day 30 (one month after vaccination))