NCT04596696已完成3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Demonstrate immunogenicity of 3-dose regimen of Rotavac
研究概览
简要总结
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
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
- •Presence of fever (>37.5C) or hypothermia (<35.5C) on the day of enrollment (temporary exclusion).
- •Concurrent participation in another clinical trial.
- •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.
- •History of congenital abdominal disorders, intussusception, abdominal surgery
- •Known or suspected impairment of immunological function based on medical history and physical examination.
- •Prior receipt of rotavirus vaccine.
- •A known sensitivity or allergy to any components of the study vaccines.
- •Major congenital or genetic defect.
- •Participant's parents not able, available or willing to accept active follow-up by the study staff.
- •Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
- •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.
- •History of any neurologic disorders or seizures.
- •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.
结局指标
主要结局
Demonstrate immunogenicity of 3-dose regimen of Rotavac
时间窗: 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
次要结局
- Assess and compare reactogenicity and safety (adverse events)(At the end of 28 days after last dose)
研究者
研究点 (1)
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