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Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac in Healthy Infants in Vietnam

2020年10月21日 更新者:Bharat Biotech International Limited

An Open Label Study to Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® (Live Attenuated Rotavirus Vaccine) as a 3-dose Series in Healthy Infants Aged Between 6 Weeks and 8 Weeks in Vietnam

An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live attenuated oral rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks and 8 weeks in Vietnam

研究概览

地位

完全的

干预/治疗

详细说明

  • The study is an open labeled, clinical trial in infants 6-8 weeks of age will be assigned to receive 3 doses of Rotavac® to evaluate the immunogenicity and safety.
  • Active surveillance will be conducted for all participants for 14 & 28 days after each dose of vaccine to obtain information on adverse events. ("Reactogenicity")
  • Childhood vaccines including pentavalent (Diptheria, Tetanus, Pertussis, Hib, Hepatitis B) and oral polio vaccine as well as injectable polio vaccine will be administered along with the study vaccines as per Expanded Program on Immunization (EPI)
  • Safety assessments will include observation in the study clinic for 30 minutes after each vaccine administration to record immediate adverse events. A subject diary card and personal contact with the subjects will be made to record adverse events during the 14-day period following vaccine administration.

研究类型

介入性

注册 (实际的)

360

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Hanoi、越南
        • Vietnam Military Medical University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1个月 至 1个月 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria

  1. Healthy infants as established by medical history and clinical examination
  2. Age: 6-8 weeks
  3. Weight ≥2.5kgs at birth
  4. Infants receiving EPI vaccines as per Vietnam immunization program
  5. Parental ability and willingness to provide informed consent.
  6. Parent who intends to remain in the area with the participant during the study period.

Exclusion Criteria:

  1. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
  2. Presence of fever (>37.5C) or hypothermia (<35.5C) on the day of enrollment (temporary exclusion).
  3. Concurrent participation in another clinical trial.
  4. Presence of significant malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, immuno-logical, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the child's health or is likely to result in non-conformance to the protocol.
  5. History of congenital abdominal disorders, intussusception, abdominal surgery
  6. Known or suspected impairment of immunological function based on medical history and physical examination.
  7. Prior receipt of rotavirus vaccine.
  8. A known sensitivity or allergy to any components of the study vaccines.
  9. Major congenital or genetic defect.
  10. Participant's parents not able, available or willing to accept active follow-up by the study staff.
  11. Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
  12. History of chronic administration (defined as more than 14 days) of immunosuppressant including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
  13. History of any neurologic disorders or seizures.
  14. Any medical condition in the parents/ infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent's/legally acceptable representative's ability to give informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Single arm Rotavac
Single arm Open Label study without comparator
Rotavac Is a monovalent vaccine containing suspension of live attenuated rotavirus 116E strain, a naturally occurring reassortant strain G9P[11], containing one bovine rotavirus gene P[11] and 10 human rotavirus genes prepared in Vero cells administered orally at 6, 10 and 14 weeks of age.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Demonstrate immunogenicity of 3-dose regimen of Rotavac
大体时间:At the end of 28 days after last dose
Immunogenicity of 3-dose regimen of Rotavac with respect to geometric mean titres (GMT) of serum anti-rotavirus IgA at baseline and post-vaccination 4-6 weeks after third dose
At the end of 28 days after last dose

次要结果测量

结果测量
措施说明
大体时间
Assess and compare reactogenicity and safety (adverse events)
大体时间:At the end of 28 days after last dose
Reactogenicity and safety of Rotavac in terms of adverse event
At the end of 28 days after last dose

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Dr Krishana Mohan, MD、Bharat Biotech International Limited

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年12月20日

初级完成 (实际的)

2018年12月30日

研究完成 (实际的)

2019年6月30日

研究注册日期

首次提交

2018年5月14日

首先提交符合 QC 标准的

2020年10月20日

首次发布 (实际的)

2020年10月22日

研究记录更新

最后更新发布 (实际的)

2020年10月23日

上次提交的符合 QC 标准的更新

2020年10月21日

最后验证

2020年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • BBIL/ROTAVAC/Vietnam/2017

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Rotavac的临床试验

3
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