A Phase 3, Randomized, Double-Blind, Active-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Subjects 50 Years of Age and Older With Immunobridging to Subjects 18-49 Years of Age
概览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 4,000
- 试验地点
- 60
- 主要终点
- Serotype-specific OPA geometric mean titers (GMT) in 50 year olds and above
概览
简要总结
The primary objectives of this study are to evaluate the safety, tolerability, immunologic noninferiority (for shared serotypes) and immunologic superiority (for novel serotypes) of VAX-31 compared to PCV21 and PCV20 in adults ≥50 years of age, and to bridge the immune responses induced by VAX-31 in adults 50-64 years of age to adults 18-49 years of age.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female ≥18 years of age (inclusive) at the time of randomization into the study.
- •Able and willing to complete the informed consent process.
- •Available for clinical follow-up through the last study visit.
- •In good general health or with stable underlying chronic condition(s), as determined by medical history, oral temperature, physical examination, and clinical judgment of the Investigator (ongoing chronic conditions must be documented as stable per Investigator).
- •Willing to have blood samples collected and used for research purposes.
- •Able to provide proof of identity to the satisfaction of the site personnel completing the enrollment process.
- •Female participants of childbearing potential, defined as premenopausal females capable of becoming pregnant, must have a negative urine pregnancy test immediately prior to randomization and agree to use acceptable contraception. Male subjects with partners of childbearing potential must agree to practice an acceptable contraception method.
- •Able to access and use a device connected to Wi-Fi or cellular network for completion of an electronic diary (eDiary).
排除标准
- •History of invasive pneumococcal disease (IPD) or pneumococcal pneumonia (either confirmed or self-reported) at any age.
- •Previous receipt of any licensed or investigational pneumococcal vaccine at any age.
- •Receipt of any investigational product within 30 days prior to Day 1, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
- •Receipt of any live vaccine within 30 days prior to Day 1, or receipt of any non-live (including inactivated) vaccine within 14 days prior to Day
- •Body temperature \>38.0°C (\>100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescreened).
- •Current diagnosis of human immunodeficiency virus, Hepatitis B, or Hepatitis C.
- •History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any previous vaccination.
- •Individual who is pregnant, breastfeeding, or planning to become pregnant during study participation.
- •Has a known or suspected immunocompromising condition, including, but not limited to, leukemia, lymphoma, chronic renal failure, or congenital or acquired immunodeficiency.
- •Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) resulting in clinically significant bruising or bleeding difficulties with IM injections or blood draws.
研究组 & 干预措施
Cohort 1 (VAX-31), participant ≥ 50 years of age
Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1
干预措施: 31 valent pneumococcal conjugate vaccine (Biological)
Cohort 1 (PCV21), participant ≥ 50 years of age
Participants will receive a single dose of PCV21 (Capvaxive) administered via intramuscular injection at Day 1
干预措施: PCV21 (Biological)
Cohort 1 (PCV20), participant ≥ 50 years of age
Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1
干预措施: PCV20 (Biological)
Cohort 2 (VAX-31), participant 18-49 years of age
Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1
干预措施: 31 valent pneumococcal conjugate vaccine (Biological)
Cohort 2 (PCV20), participant 18-49 years of age
Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1
干预措施: PCV20 (Biological)
结局指标
主要结局
Serotype-specific OPA geometric mean titers (GMT) in 50 year olds and above
时间窗: 1 month after vaccination
Percentage of subjects reporting solicited local adverse events (AE) (redness, swelling, and pain at injection site)
时间窗: up to 7 days after vaccination
Percentage of subjects reporting solicited systemic AE (fever, headache, fatigue, muscle pain, and joint pain)
时间窗: up to 7 days after vaccination
Percentage of subjects reporting unsolicited AE
时间窗: up to 31 days after vaccination
Percentage of subjects reporting serious adverse events (SAE), new onset of chronic illness (NOCI), and medically attended adverse events (MAAE)
时间窗: up to 6 Months after vaccination
Serotype-specific OPA geometric mean titers (GMT) in 18 to 49 year olds and 50 to 64 year olds
时间窗: 1 month after vaccination
次要结局
- Serotype-specific IgG geometric mean concentrations (GMC) in 50 year olds and above(1 month after vaccination)
- Serotype-specific IgG GMC in 18 to 49 year olds and 50 to 64 year olds(1 month after vaccination)