To Evaluate the Long-term Persistence of Rotavirus Antibody Responses in Children Previously Vaccinated With a 3-Dose Infant Schedule or 4-Dose Neonatal Schedule with ROTAVACÂ® -20ï?°C or ROTAVAC 5DÂ® (BBIL/ROTAVAC/III/2018). - Rotavac@Birth phase 3 extension study

Bharat Biotech International Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Subjects who previously participated in the main study
•Subjects whose either of parent or guardian is able to understand planned study procedures and demonstrate comprehension of the protocol procedures
•Subjects whose parent or guardian, in the opinion of the investigator can and will comply with the requirements of the protocol
•Written informed consent obtained from the subjects parent or guardian prior to performance of any study specific procedure

•Any of the following criteria will preclude the participant from being enrolled in the study:
•1. Use of any investigational or non-registered product (drug or vaccine) other than
•the study vaccines (apart from BBIL/ROTAVAC/III/2018 study) during the study
•2. Concurrently participating in another clinical study, at any time during the study
•period, in which the subject has been or will be exposed to an investigational or a
•non-investigational vaccine/product (pharmaceutical product or device).
•3. Acute disease and/or fever at the time of enrolment.
•a. Fever is defined as temperature >=38.0Â°C/100.4Â°F. The preferred location for
•measuring temperature in this study will be underarm (axillary) temperature.
•b. Subjects with acute diarrhea and/or vomiting within last 24 hours.
•4. Any medical condition in the parents/infant which, in the judgment of the
•Investigator, would interfere with or serves as a contraindication to protocol

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