NCT03483116已完成2 期
A Phase II Randomized, Double Blind, Parallel Group Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine Administered at a High, Mid and Low Titre as a 3 Dose Neonate Schedule or Administered at a High Titre as a 3 Dose Infant Schedule.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 711
- 试验地点
- 1
- 主要终点
- Number of Participants With a Cumulative Anti Rotavirus Serum Immunoglobulin A (IgA) Response (≥3 Fold Increase From Baseline) in Neonatal Vaccine Schedule at High Mid and Low Dose of RV3-BB
研究概览
简要总结
The purpose of this study is to determine the serum IgA response of three dose levels of the oral RV3-BB vaccine when administered in a neonatal schedule or when administered as a high dose in an infant schedule.
详细描述
The primary objective of this study is to assess the cumulative anti-rotavirus serum IgA response (defined as a ≥3 fold increase from baseline) 4 weeks after 3 doses of RV3-BB administered in a neonatal schedule at a High, Mid or low vaccine titre. In addition the cumulative anti-rotavirus serum IgA response (defined as a ≥3 fold increase from baseline) 4 weeks after 3 doses of RV3-BB administered in an infant schedule at a high dose of vaccine will be assessed along with cumulative vaccine take and components of vaccine take after 3 doses of RV3-BB administered in a neonatal or infant schedule.
The safety and tolerability of RV3-BB when administered as an infant or as a neonatal schedule will be described.
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
- 0 Days 至 18 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neonate is less than 6 days (≤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.
- •Neonate birth weight 2500-4000g inclusive.
- •Neonate's parents/guardians expect to be available for the duration of the study, and agree to adhere to all protocol requirements.
- •Neonate's parents/guardians have provided written informed consent prior to study-related procedures being performed.
排除标准
- •Any medical, psychiatric, or social condition of a parent/guardian that in the opinion of the investigator would prevent the neonate's parents/guardians from giving proper informed consent or from complying with the study protocol.
- •Neonates with known or suspected major congenital malformations or genetically determined disease.
- •Neonates with intussusception.
- •Neonates with a known or suspected bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- •Neonates who have ever received any blood products, including immunoglobulin, or for whom receipt of any blood product during the course of the study is anticipated.
- •Neonates in whom Essential Programme Immunisation (EPI) vaccines or components are contraindicated.
- •Neonates who have received or who expect to receive during the study period, any rotavirus vaccine other than those which will be administered as part of this study.
- •Neonates who have ever received, or who are anticipated to receive during the study period, any investigational agent other than those which will be administered as part of this study.
- •Neonates with a previous anaphylactic reaction to any drug, vaccine or vaccine component.
- •Neonates with a significant evolving neurological disorder.
- •Neonates whose parents/guardians are site team employees with direct involvement with the investigators, or who are working on the study.
- •Neonates who have been exposed to immunosuppressive courses of glucocorticosteroids, cytotoxic drugs or blood products through prenatal exposure and/or breast milk in the four weeks prior to randomization.
- •Neonates with diarrhoea or vomiting in the 24 hours preceding randomisation.
- •Neonates with any moderate or severe illness, and/or who have a temperature of ≥37.5˚C axillary/oral or ≥38˚C rectal/tympanic within the 48 hours preceding randomization.
结局指标
主要结局
Number of Participants With a Cumulative Anti Rotavirus Serum Immunoglobulin A (IgA) Response (≥3 Fold Increase From Baseline) in Neonatal Vaccine Schedule at High Mid and Low Dose of RV3-BB
时间窗: At serum collection at approximately 14 weeks of age
Cumulative anti rotavirus serum Immunoglobulin A (IgA) response is defined as a ≥3 fold increase from baseline at each serum collection time point to 4 weeks after 3 doses of RV3-BB
次要结局
- Number of Participants With a Cumulative Anti Rotavirus Serum IgA Response (≥3 Fold Increase From Baseline) After 3 Doses in an Infant RV3-BB Schedule(At serum collection visit approximately 18 weeks of age)
- Serum Anti Rotavirus IgA Titres in Participants Receiving RV3-BB in a Neonatal or Infant Schedule(At serum collection time points at approximately 14 and 18 weeks of age)
- Number of Participants With a Cumulative "Vaccine Take" (Serum Anti Rotavirus IgA Response or Shedding of RV3-BB Vaccine Virus) and Components of Vaccine Take After 3 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a High Dose of RV3-BB.(Sample collections at Week 0 through to approximately 14 and 18 weeks of age)
- Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 3 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a Mid or Low Dose of RV3-BB(Sample collections at Week 0 through to approximately 14 and 18 weeks of age)
- Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 1 Dose of RV3-BB Administered in a Neonatal or Infant Schedule at a High, Mid or Low Dose of RV3-BB(Sample collections at Week 0 through to approximately 6 and 10 weeks of age)
- Occurrence of Diarrhea. Severe(First dose of Investigational product to Study End at approximately 18 weeks of age)
- Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 2 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a High, Mid or Low Dose of RV3-BB(Sample collections at Week 0 through to approximately 10 and 14 weeks of age)
- Occurrence of Adverse Events (AE)(First dose of investigational product to Study End at approximately 18 weeks of age)
- Occurrence of Serious Adverse Events (SAEs)(First dose of investigational product to Study End at approximately 18 weeks of age)
研究者
研究点 (1)
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