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
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Frequency and rate of the AEs within 7 days after vaccination
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.
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
盲法说明
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
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
- •Healthy infants as established by medical history and clinical examination before entering the study.
- •Age: 6-8 weeks
- •Weight ≥ 2.5kg at birth.
- •Infants received EPI vaccines at birth (i.e., OPV, BCG and/or Hep B)
- •Parental ability and willingness to provide informed consent.
- •Parent who intends to remain in the area with the participant during the study period.
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 (temperature ≥37.5oC) or hypothermia (temperature ≤35.5oC) 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, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the infant'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 medication.
- •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 immunosuppressants 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.
研究组 & 干预措施
Rotavirus Vaccine
3 dose, interval for each dose is 4 weeks. The first dose will be received at 6-8 weeks of age.
干预措施: ROTAVAC® (Biological)
结局指标
主要结局
Frequency and rate of the AEs within 7 days after vaccination
时间窗: for 7 days after each vaccination
Frequency and rate of adverse effects and severity of solicited adverse events (Local and General) within 7 days after each vaccination
Frequency and rate of the AEs within 30 minutes after vaccination
时间窗: 30 minutes after vaccination
Frequency and rate of the adverse effects and severity of immediate adverse events (Local and General) within 30 minutes after vaccination
Frequency and rate of the AEs during 28 days after vaccination
时间窗: for 28 days after vaccination
Frequency and rate of adverse effects and severity of unsolicited adverse events (Local and General) during 28 days after each vaccination
Frequency and rate of the SAEs during 28 days after vaccination
时间窗: for 28 days after vaccination
Frequency and rate of adverse effects and severity of Serious Adverse Events (Local and General) during 28 days after each vaccination
次要结局
未报告次要终点
研究者
Pham Ngoc Hung, MD PhD Assoc
Principal Investigator
Vietnam Military Medical University