A Phase II/III, Multicenter, Observer-Blinded, Randomized, Non-inferiority and Safety Study of Typhoid Conjugate Vaccine (EuTCV) Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 444
- 试验地点
- 2
- 主要终点
- Proportion of Solicited local and systemic AEs
研究概览
简要总结
This is an observer-blinded, comparative, single dose, clinical phase II/III study to assess the immunogenicity and safety of EuTCV compared to Typhoid conjugate vaccine in healthy Filipino participants aged 6 months to 45 years.
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
- 6 Months 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants ≥6 months and ≤45 years of age at enrolment
- •Participants/Parents/Legally Authorized Representative(LAR) willing to give written informed consent/assent to participate in the trial
- •Participants/Parents/LAR willing to follow the study procedures of the study and available for the entire duration of the study
- •Participants who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests
- •Female participants must have a negative serum (at Screening) and negative urinary (at Day 1) pregnancy test and agree to use 2 methods of contraception from dosing until 90 days after vaccination.
排除标准
- •Participants/Parents/LAR unwilling to give his/her consent/assent to participate in the trial
- •Participants concomitantly enrolled or scheduled to be enrolled in another trial
- •Children and infants with a congenital abnormality
- •Known history of immune function disorders including immunodeficiency disease, or chronic use of systemic steroids, cytotoxic or other immunosuppressive drugs
- •Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
- •History of uncontrolled coagulopathy or blood disorders
- •Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the trial objectives
- •History of alcohol or substance abuse
研究组 & 干预措施
Arm A (Vi-CRM197, Batch #1)
Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #1 will be intramuscularly administered at Day 0.
干预措施: EuTCV (Vi-CRM Typhoid conjugate vaccine) (Biological)
Arm A (Vi-CRM197, Batch #2)
Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #2 will be intramuscularly administered at Day 0.
干预措施: EuTCV (Vi-CRM Typhoid conjugate vaccine) (Biological)
Arm A (Vi-CRM197, Batch #3)
Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #3 will be intramuscularly administered at Day 0.
干预措施: EuTCV (Vi-CRM Typhoid conjugate vaccine) (Biological)
Arm D (Typbar-TCV)
Single dose of Typhoid Conjugate Vaccine (Typbar-TCV) will be intramuscularly administered at Day 0.
干预措施: Typbar-TCV (Biological)
结局指标
主要结局
Proportion of Solicited local and systemic AEs
时间窗: 7 days after vaccination
Seroconversion rate
时间窗: 4 weeks after vaccination of EuTCV (pooled of 3 batches)/Typbar-TCV compared to baseline
Proportion of unsolicited AEs
时间窗: within 28 days after vaccination
次要结局
未报告次要终点