NCT03462108已完成1 期
A Prospective Intervention Phase I Study in Three Age De-escalating Group to Assess the Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Solicited symptoms after each immunization
研究概览
简要总结
This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates.
详细描述
To describe the safety of this vaccine after each immunization. To assess preliminary information of immunogenicity following Rotavirus (Bio Farma) vaccine immunization.
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)
盲法说明
The study for the neonates is double-blind, randomized study. While, the study for the adults and childrens is open-labeled study
入排标准
- 年龄范围
- 1 Minute 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Adults:
- •Healthy Adults as determined by clinical judgment, including a medical history, physical exam and laboratory results, which confirms the absence of a current or past disease state considered significant by the investigator.
- •Subjects have been informed properly regarding the study and signed the informed consent form.
- •Subject will commit to comply with the instructions of the investigator and the schedule of the trial.
- •Inclusion Criteria for Children:
- •Healthy Children 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.
- •Parents/guardian(s) have been informed properly regarding the study and signed the informed consent form
- •Parent/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.
- •Inclusion Criteria for Neonates:
- •Neonate 0-5 days of age at the time of first dose, with cord blood available
- •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 36 completed weeks and maximum of 42 completed weeks gestation).
- •Neonate birth weight 2500-4000 g inclusive.
- •Parents or guardians have been informed properly regarding the study and signed the informed consent form
- •Parents or guardians will commit to comply with the instructions of the investigator and the schedule of the trial
排除标准
- •for Adults:
- •Subject concomitantly enrolled or scheduled to be enrolled in another trial
- •Any direct relatives relationship with the study team.
- •Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment.
- •Known history of allergy to any component of the vaccines
- •Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy)
- •Gastroenteritis in the 24 hours preceding enrollment.
- •History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
- •Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or corticosteroid therapy and other immunosuppresant).
- •Subject consuming or expect to consume a probiotics within one week before and after vaccination
- •Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
- •Pregnancy & lactation (Adults).
- •Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
- •Subject planning to move from the study area before the end of study period.
- •Exclusion Criteria for Children:
- •Subject concomitantly enrolled or scheduled to be enrolled in another trial
- •Any direct relatives relationship with the study team
- •Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C ) within the 48 hours preceding enrollment
- •Known history of allergy to any component of the vaccines
- •Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy)
- •Gastroenteritis in the 24 hours preceding enrollment.
- •Any clinically significant history of chronic gastrointestinal disease including uncorrected congenital malformation of gastrointestinal tract that would predispose for Intusussception.
- •History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
- •Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or corticosteroid therapy and other immunosuppresant).
- •Subjects consuming or expect to consume a probiotics within one week before and after vaccination.
- •Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
- •Individuals who have previously received any rotavirus vaccine.
- •Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
- •Subject planning to move from the study area before the end of study period
- •Exclusion Criteria for Neonates:
- •Subject concomitantly enrolled or scheduled to be enrolled in another trial.
- •Any direct relatives relationship with the study team.
- •Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment.
- •Subject with known or suspected history of allergy to any component of the vaccines.
- •Subject with a biological mother with a known or suspected human immunodeficiency virus (HIV) 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 has received immunosuppresive therapy, including immunosuppresive courses of systemic corticosteroid.
- •Subject who have ever received any blood products, including immunoglobulin, or for whom receipt of any blood product 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 enrollment.
- •Subject planning to move from the study area before the end of study period.
研究组 & 干预措施
Placebo-Neonates
Placebo Comparator
3 doses of 1 ml of Placebo (contains 30% sucrose in DMEM) per oral
干预措施: Placebo (Other)
Rotavirus (Bio Farma) Vaccine-Neonates
Experimental
3 doses of 1 ml of Rotavirus vaccine per oral
干预措施: Rotavirus (Bio Farma) Vaccine (Biological)
Rotavirus (Bio Farma) Vaccine-Children
Experimental
1 doses of 1 ml of Rotavirus vaccine per oral
干预措施: Rotavirus (Bio Farma) Vaccine (Biological)
Rotavirus (Bio Farma) Vaccine-Adult
Experimental
1 doses of 1 ml of Rotavirus vaccine per oral
干预措施: Rotavirus (Bio Farma) Vaccine (Biological)
结局指标
主要结局
Solicited symptoms after each immunization
时间窗: 0-7 days
Number of subjects with solicited systemic and gastrointestinal symptoms in the day 0-7 following each dose of investigational product
次要结局
- Serious adverse events of Rotavirus (Bio Farma) vaccine(28 days)
- Adverse events of Rotavirus (Bio Farma) vaccine compare to placebo in neonates group(28 days)
- Serious adverse events of Rotavirus (Bio Farma) vaccine compare to placebo in neonates group(28 days)
- Serum neutralizing antibody (SNA) following immunization(4-6 weeks after last immunization)
- Adverse events of Rotavirus (Bio Farma) vaccine(28 days)
- Number of subject who has abnormality value of routine hematology and biochemical evaluation that probably related to the vaccination(7 days)
- Excretion of rotavirus in stools in neonates group(3-7 days)
- Number of subjects with >=3 times increasing antibody from baseline to post investigational product dosing(4-6 weeks after last immunization)
- Serum anti-rotavirus immunoglobulin (Ig)A following immunization(4-6 weeks after last immunization)
- Geometric Mean Titer (GMT) following immunization(4-6 weeks after last immunization)
研究者
研究点 (4)
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