A Randomized, Double-blind, Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Doses of VAC52416 (ExPEC10V) in Japanese Adults Aged 60 to 85 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Participants with Solicited Systemic AEs Collected for 14 days post-Vaccination
研究概览
简要总结
The purpose of this study is to evaluate the safety and reactogenicity of different doses of extraintestinal pathogenic Escherichia coli 10 valent (ExPEC10V) in Japanese participants greater than or equal to (>=) 60 to less than or equal to (<=) 85 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must be Japanese as determined by participant's verbal report
- •Must be healthy or medically stable, in the investigator's clinical judgment, as confirmed by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at the screening visit
- •Willing and able to adhere to the lifestyle restrictions
- •Agrees not to donate blood until 12 weeks after receiving the study intervention
- •Must be willing to provide verifiable identification, has means to be contacted, and to contact the investigator during the study
排除标准
- •Clinically significant illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius (100.4 degree Fahrenheit ) within 24 hours prior to the administration of study intervention; enrollment at a later date is permitted (provided the screening window of 28 days is respected)
- •History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
- •Known allergies, hypersensitivity, or intolerance to ExPEC10V or its excipients
- •Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine excipients
- •Contraindication to Intramuscular (IM) injections and blood draws example, bleeding disorders
研究组 & 干预措施
Medium-dose ExPEC10V or Placebo: Group 1
Participants will be randomized to receive a single intramuscular (IM) injection of medium dose of ExPEC10V or Placebo on Day 1.
干预措施: Placebo (Biological)
High-dose ExPEC10V or Placebo: Group 2
Participants will be randomized to receive a single IM injection of high dose (based on safety assessment through Day 15 postvaccination of medium dose) of ExPEC10V or Placebo on Day 1.
干预措施: Placebo (Biological)
High-dose ExPEC10V or Placebo: Group 2
Participants will be randomized to receive a single IM injection of high dose (based on safety assessment through Day 15 postvaccination of medium dose) of ExPEC10V or Placebo on Day 1.
干预措施: ExPEC10V (Biological)
Medium-dose ExPEC10V or Placebo: Group 1
Participants will be randomized to receive a single intramuscular (IM) injection of medium dose of ExPEC10V or Placebo on Day 1.
干预措施: ExPEC10V (Biological)
结局指标
主要结局
Number of Participants with Solicited Systemic AEs Collected for 14 days post-Vaccination
时间窗: 14 days post-Vaccination (Up to Day 15)
Number of participants with solicited systemic AEs will be reported. Solicited systemic AEs (oral body temperature, headache, fatigue, nausea, and myalgia) will be noted in the participant diary for 14 days post-vaccination.
Number of Participants with Unsolicited AEs From the Administration of Study Vaccine until 29 Days post-Vaccination
时间窗: From the administration of study vaccine until 29 days post-Vaccination (Up to Day 30)
Number of participants with unsolicited AEs will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participants diary.
Number of Participants with Solicited Local Adverse Events (AEs) Collected for 14 days post-Vaccination
时间窗: 14 days post-Vaccination (Up to Day 15)
Number of participants with solicited local AEs will be reported. Solicited local AEs (pain/tenderness, erythema, and swelling at the injection site) and will be noted in the participant diary for 14 days post-vaccination.
Number of Participants with Serious AEs from the Administration of the Study Vaccine until Day 181
时间窗: From the administration of study vaccine until 180 days post-Vaccination (Up to Day 181)
Number of participants with SAEs will be reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
次要结局
- Antibody Titers for ExPEC10V as Determined by Multiplex ECL-based Immunoassay(Days 15 and 30)
- Antibody Titers for ExPEC10V as Determined by Multiplex Opsonophagocytic Assay (MOPA)(Day 15 and 30)