An Open Label Clinical Trial To Assess The Safety And Tolerability Of A Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) Formulation In Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1. Occurrence of immediate adverse events within 60 minutes.
研究概览
简要总结
This is a phase I, open labelled study to assess the safety and tolerability of a Liquid formulation of Bovine Rotavirus Pentavalent Vaccine (LBRV-PV), in healthy adults.
A total of 20 subjects will be enrolled in the study at single site to receive LBRV-PV. Active surveillance for vaccine reactogenicity (solicited reactions) over the 7-day period after vaccination will be conducted on all subjects. In addition, surveillance for unsolicited AEs and SAEs will be carried out over the period between enrollment and four weeks after vaccination on all subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy adult male or non-pregnant female subjects aged between 18-45 years and normal Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg weight.
- •Normal health as determined by medical history, clinical examination and laboratory assessment.
- •Subjects willing to adhere to the protocol requirements and to provide written informed consent
- •Availability for clinical follow up through period of the study.
排除标准
- •Investigator site personnel directly affiliated with this study and their immediate families.
- •Fever or any acute infection at time of immunization.
- •History of diarrhea or blood in stool or abnormal stool pattern in past one week.
- •A known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccine or a vaccine containing the same substances.
- •History or presence of asthma, urticaria or other allergic reaction.
- •History of chronic gastrointestinal disease, intussusceptions, gastrointestinal malformation or abdominal surgery.
结局指标
主要结局
1. Occurrence of immediate adverse events within 60 minutes.
时间窗: within 60 minutes; | within 7-day post-vaccination follow-up period; | within 28 days after vaccination.
2. Occurrence of solicited reactions within 7-day post-vaccination follow-up
时间窗: within 60 minutes; | within 7-day post-vaccination follow-up period; | within 28 days after vaccination.
period.
时间窗: within 60 minutes; | within 7-day post-vaccination follow-up period; | within 28 days after vaccination.
3. Occurrence of unsolicited adverse events, including serious adverse events
时间窗: within 60 minutes; | within 7-day post-vaccination follow-up period; | within 28 days after vaccination.
within 28 days after vaccination.
时间窗: within 60 minutes; | within 7-day post-vaccination follow-up period; | within 28 days after vaccination.
次要结局
- Occurrence of unsolicited adverse events, including serious adverse(events within 28 days after vaccination.)