NCT04185545已完成3 期
Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates, Lot to Lot Consistency and Antigen Interference With Co-Administered EPI Vaccines (Phase III)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 1,400
- 试验地点
- 21
- 主要终点
- Efficacy of three doses against severe acute rotavirus gastroenteritis
研究概览
简要总结
This phase III trial aims to assess the efficacy, safety and immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in neonates, lot-to-lot consistency, and antigen interference with co-administered EPI vaccines
详细描述
This study is a randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and immunogenicity following three doses of rotavirus RV3 vaccine (Bio Farma) administered as a neonatal schedule
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Minute 至 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neonate 0-5 days (0-144 hours) of age at the time of first dose.
- •Neonate is in good health as determined by clinical judgment, including a medical history and physical exam, which confirms the absence of a current or past disease state considered significant by the investigator.
- •The neonate was born full term (minimum of 37 completed weeks and maximum of 42 completed weeks gestation).
- •Neonate birth weight 2500-4000 g inclusive.
- •Parent or guardian has been informed properly regarding the study and signed the informed consent form.
- •Parent or guardian commits to comply with the instructions of the investigator and the schedule of the trial.
排除标准
- •Subject concomitantly enrolled or scheduled to be enrolled in another trial.
- •The subject has direct relatives relationship with the study team.
- •The subject has evolving mild, moderate or severe illness, especially infectious diseases or fever (body temperature 37.5°C) within the 48 hours preceding enrollment.
- •Subject with a known or suspected history of allergy to any component of the vaccines (based on anamnesis).
- •Subject with a biological mother with a known or suspected human immunodeficiency virus (HIV) or Hepatitis B infection.
- •Subject with known or suspected major congenital malformations or genetically determined disease.
- •Subject with intussusception.
- •Subject with a known or suspected disease of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
- •Subject with a known or suspected disease of the immune system or those who have received immunosuppressive therapy, including immunosuppressive courses of systemic corticosteroid.
- •Subject who have ever received any blood products, including immunoglobulin, or for whom receipt of any blood product is anticipated during the course of study.
- •Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
- •Subject immunized with non-EPI vaccines.
- •Gastroenteritis in the 24 hours preceding dosing (temporary exclusion criteria).
- •Subject planning to move from the study area before the end of the study period.
结局指标
主要结局
Efficacy of three doses against severe acute rotavirus gastroenteritis
时间窗: 2 weeks after three doses to 18 months of age
Episodes of severe rotavirus gastroenteritis (defined as a modified Vesikari score ≥ 11 and rotavirus antigen detected in stool by ELISA)
次要结局
- Efficacy of three doses against rotavirus gastroenteritis of any severity and all-cause gastroenteritis(2 weeks after three doses to 18 months of age)
- Serum immune response (sIgA) after third dose(28 days after the third dose)
- Stool excretion following each dose(3-5 days after each dose)
- Cumulative serum immune response(28 days after each dose)
- Lot to lot consistency(28 days after the third dose)
- Serum immune response (sIgA) after the second dose(28 days after the second dose)
- Abnormality of ALT and AST levels(28 days after the first dose)
- Immune interference(28 days after non-EPI vaccination)
- Solicited and unsolicited adverse events (AE)(Up to 28 days after the third dose)
- Serious adverse events (SAE)(Up to 28 days after the third dose)
- Serum immune response (sIgA) after the first dose(28 days after the first dose)
- Geometric Mean Titre (GMT)(28 days after each dose)
- Serum neutralizing antibodies (SNA) after the third dose(28 days after the third dose)
研究者
研究点 (21)
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