An Open Label Clinical Trial To Assess The Safety And Tolerability Of A Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) Formulation In Healthy Adults

Serum Institute of India Limited0 个研究点目标入组 20 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. 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.
•2. Normal health as determined by medical history, clinical examination and
•laboratory assessment.
•3. Subjects willing to adhere to the protocol requirements and to provide
•written informed consent
•4. Availability for clinical follow up through period of the study.

•1. Investigator site personnel directly affiliated with this study and their immediate families.
•2. Fever or any acute infection at time of immunization.
•3. History of diarrhea or blood in stool or abnormal stool pattern in past one week.
•4. 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.
•5. History or presence of asthma, urticaria or other allergic reaction.
•6. History of chronic gastrointestinal disease, intussusceptions, gastrointestinal malformation or abdominal surgery.

发起方

Serum Institute of India Limited