A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of a Pneumococcal Conjugate Vaccine (V114) Compared to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX® 23) and PREVNAR 13® (Pneumococcal 13-Valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in Healthy Adults 50 Years of Age or Older
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 692
- 主要终点
- Percentage of Participants With an Adverse Event
研究概览
简要总结
The purpose of the study is to see if an investigational vaccine for Streptococcus pneumonia disease (V114) has comparable safety, tolerability, and antibody response to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX® 23) and 13-valent Pneumococcal Conjugate Vaccine (PREVNAR 13®) when administered to healthy adults 50 years of age or older.
The primary hypothesis is the serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) as measured by the pneumococcal electrochemiluminescence (Pn ECL) assay at one month postvaccination in subjects who receive V114 will be noninferior to those measured in subjects who receive PNEUMOVAX® 23.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Without fever for 72 hours prior to vaccination
排除标准
- •Prior receipt of any pneumococcal polysaccharide vaccine or any pneumococcal conjugate vaccine
- •Known or suspected to be immunocompromised
- •Functional or anatomic asplenia
- •History of autoimmune disease
- •Evidence of dementia or cognitive impairment
- •Use of any immunosuppressive therapy
- •Received a licensed non-live vaccine administered within the 14 days prior to receipt of study vaccine or scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine
- •Received a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days of receipt of study vaccine
- •Received any vaccine containing diphtheria toxoid within 6 months prior to receipt of study vaccine
- •Received a blood transfusion or blood products within the 6 months before receipt of study vaccine or scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine
- •History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
- •Received antibiotic therapy for any acute illness within 72 hours before receipt of study vaccine
研究组 & 干预措施
V114
Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.
干预措施: Pneumococcal Conjugate Vaccine (V114) (Biological)
PNEUMOVAX® 23
Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.
干预措施: PNEUMOVAX® 23 (Biological)
PREVNAR 13®
Healthy adult participants received 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 an Adverse Event
时间窗: All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies
时间窗: One month postvaccination
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence (ECL) assay.
Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups
时间窗: Up to Day 14 postvaccination
Systemic AEs reported by \>=2% of participants in one or more vaccination groups were assessed.
Percentage of Participants With a Serious Adverse Event
时间窗: Up to 6 months postvaccination
A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
Percentage of Participants With a Vaccine-related Serious Adverse Event
时间窗: Up to 6 months postvaccination
A SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs deemed by the investigator to be possibly, probably, or definitely related to study vaccine were reported.
Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups
时间窗: Up to Day 14 postvaccination
Injection-site AEs reported by \>=2% of participants in one or more vaccination groups were assessed.
次要结局
- Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies(One month postvaccination)