PACTR201907491834482招募中3 期
A Phase 3 double-blind, randomized, active comparator-controlled, group-sequential, multinational trial to assess the safety, immunogenicity and efficacy of a trivalent rotavirus P2-VP8 subunit vaccine in prevention of severe rotavirus gastroenteritis in healthy infants
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- PATH
- 入组人数
- 8,200
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
- •Healthy infants as established by medical history and clinical examination before randomization into the study
- •Age: =6 and <8 weeks at the time of first study vaccination (42 days through 55 days old, inclusive, with the day after birth considered 1-day
- •Parental ability and willingness to provide written informed consent
- •Intention of the participants’ parents to remain in the area with the child during the study period
排除标准
- •Acute disease at the time of enrollment/first study vaccination - temporary exclusion
- •Presence of fever on the day of enrollment/first study vaccination (axillary temperature >37.6C) - temporary exclusion
- •Concurrent participation in another clinical trial throughout the entire timeframe for this study (participation in non-interventional observational study is allowed if there is no blood draw)
- •Presence of severe malnutrition (weight-for-height z-score =-3SD median (per WHO published child growth standards) or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination that would compromise the participant’s health or is likely to result in nonconformance to the protocol
- •History of premature birth (<37 weeks gestation) and/or birth weight of <2.5 kg
- •History of congenital abdominal disorders, intussusception, or abdominal surgery
- •Prior receipt of rotavirus vaccine
- •Known sensitivity or allergy to any components of the study vaccine
- •Contraindications to any of the EPI/UIP vaccines
- •History of anaphylactic reaction
- •Major congenital or genetic defect
- •Parents not able, available or willing to accept active weekly follow-up by the study staff
- •Receipt of any immunoglobulin therapy and/or blood products
- •History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids (those on
- •inhaled or topical steroids may be permitted to participate in the study)
- •Any medical condition in the participant or parents that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a parents’ ability to give informed consent
- •Exclusion of nursing infants whose mothers are receiving immunosuppressive biologics
研究者
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