A Phase 1, Placebo-controlled, Randomized, Observer-blind Study to Describe the Safety, Reactogenicity and Immunogenicity of a Bivalent Recombinant RSV Vaccine (SCB-1019T) in Children 2 to <6 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Evaluate porportion of participants with solicied AEs of SCB-1019T vaccine
研究概览
简要总结
This phase 1 study in Australia will evaluate the safety, reactogenicity and immunogenicity of the Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) in children 2-<6 years of age.
详细描述
This Phase 1 randomized, placebo-controlled, observer-blind study will evaluate the safety, reactogenicity and immunogenicity of different formulations of SCB-1019T vaccine in children 2-<6 years of age. A placebo is used as a control in the study because there is no licensed RSV comparator vaccine available for young children globally.
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
- 24 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants 2 to <6 years of age at Visit
- •Parents/guardians of participants willing and able to provide written informed consent and comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures. • Healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator.
- •For full inclusion criteria, please refer to full protocol.
排除标准
- •Acute disease or fever (≥38°C) at time of vaccination. For participants with minor illness and/or fever at the time of vaccination, Visit 1 may be rescheduled.
- •Evidence of chronic diseases including hepatitis, bleeding disorders, metabolic diseases, autoimmune diseases, neurological conditions that impair respiratory functions, genetic disorders that increase the risk of severe respiratory diseases, major congenital malformations, cardiac and lung diseases or reactive airway diseases.
- •For full Exclusion criteria, please refer to full protocol
研究组 & 干预措施
Group 1 (low dose SCB-1019T )
24 children (2-<6 years of age) will receive low-dose unadjuvanted SCB-1019T at Day 1
干预措施: low dose SCB-1019T (Biological)
Group 2 (adjuvanted low dose SCB-1019T)
24 children (2-<6 years of age) will receive low-dose adjuvanted SCB-1019T at Day 1
干预措施: adjuvanted low dose SCB-1019T (Biological)
Group 3 (Placebo)
8 children (2-<6 years of age) will receive placebo at Day 1
干预措施: Placebo (Other)
Group 4 (high dose SCB-1019T)
24 children (2-<6 years of age) will receive high-dose unadjuvanted SCB-1019T at Day 1
干预措施: high dose SCB-1019T (Biological)
Group 5 ( adjuvanted high dose SCB-1019T)
24 children (2-<6 years of age) will receive high-dose adjuvanted SCB-1019T at Day 1
干预措施: adjuvanted high dose SCB-1019T (Biological)
Group 6 (Placebo)
8 children (2-<6 years of age) will receive placebo at Day 1
干预措施: Placebo (Other)
结局指标
主要结局
Evaluate porportion of participants with solicied AEs of SCB-1019T vaccine
时间窗: Within 7 days after vaccination
Porportion of participants with local and systemic solicied AEs
Evaluate porportions of participants with unsolicited AEs of SCB-1019T vaccine
时间窗: Within 28 days after vaccination
Porportions of participants with unsolicited AEs
Evaluate porportions of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study of SCB-1019T vaccine
时间窗: Throughout the study period, from enrollment to 6 months follow up
Porportions of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study
次要结局
未报告次要终点