PACTR202112680671189招募中3 期
A Phase 3 Multicenter, Observer Blind, Randomized, Controlled Study to Evaluate Safety (Ages 6 Months to 45 Years) and Non-inferiority (Ages 9-12 Months) of Multi-dose and Single-dose Vial Formulations of EuTCV (Vi-CRM197 Typhoid Conjugate Vaccine) against Typbar TCV® and Lot-to-Lot Consistency of the Immune Response (Ages 9-12 Months) to Multi-dose Vial Formulation EuTCV in Healthy African Participants
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 3,255
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •1. Male or female participants, ages 6 months to 45 years (all inclusive)
- •2. Healthy as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history and clinical assessment
- •3. The participant him/herself (or his/her guardian or LAR) is informed and consents, and signs informed consent form. If the participant is above the age of assent per local ethics committee requirements, informed assent will also be sought.
- •4. Participants are able to follow the requirements of clinical trial protocol and intend to remain in the area during the study period
- •5. Individuals of childbearing capacity: Negative pregnancy test with understanding (through informed consent process) to not become pregnant during the study
- •Specific for children:
- •1. 6–36-month-olds must have a weight for height Z score of =-2 at the time of randomization
- •2. Infants must have been born >36 weeks gestation
- •3. Must have completed all age-appropriate recommended EPI vaccinations at time of randomization
排除标准
- •-Participation in research involving another IP during the 30 days before planned first vaccination or concurrently participating in another clinical study
- •-History of major congenital abdominal disorders, intussusception, abdominal surgery, or other congenital disorder or presence of significant medical condition
- •-Clinical evidence of gastrointestinal illness and acute disease (a temporary exclusion)
- •-Known or suspected impairment of immunological function based on medical history and examination. Known history of immune function disorders incl immunodeficiency disease or chronic systemic steroid use, cytotoxic or immunosuppressive drugs
- •-Breastfeeding, pregnancy, planning pregnancy during the study, or unwilling to use adequate contraception
- •-History of uncontrolled coagulopathy or blood disorders
- •-Presence of known systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease)
- •-Known history of administration of blood or blood-derived products in the past 90 days
- •-Previously ascertained or suspected disease caused by S. typhi
- •-Household contact with and/or intimate exposure to individual with laboratory-confirmed S. typhi
- •-Have received a dose of Typhoid-containing vaccine within the last 10 years
- •-Already immunised with any licensed vaccine within 4 weeks prior to enrolment/vaccination
- •-Have experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or typhoid
- •-Known hypersensitivity to any component of the study vaccines
- •-Clinically significant screening laboratory value
- •-Acute illness, infectious disease, or fever within 3 days and/or acute illness requiring antibiotic or antiviral within past 7 days
- •-Not be able to comply with any of the protocol required procedures
研究者
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