ong-term Persistence of Rotavac@birth phase 3 study in neonates and infants

Phase 3

Completed

• Registration Number: CTRI/2020/10/028458
• Lead Sponsor: Bharat Biotech International Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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

period.

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 >=38.0°C/100.4°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

adherence.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of persistence of anti-rotavirus IgA and IgG <br/ ><br>antibodies (in terms of GMT) of ROTAVAC® -20�C and <br/ ><br>ROTAVAC 5D®Timepoint: There will be 1 study visit i.e. Visit 1/Day 0.

Secondary Outcome Measures

Name	Time	Method
ot applicableTimepoint: Not applicable