A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the serum IgA response of three dose levels of the oral RV3-BB vaccine when administered in a neonatal schedule or when administered as a high dose in an infant schedule.

Clinical Trial Description

The primary objective of this study is to assess the cumulative anti-rotavirus serum IgA response (defined as a ≥3 fold increase from baseline) 4 weeks after 3 doses of RV3-BB administered in a neonatal schedule at a High, Mid or low vaccine titre. In addition the cumulative anti-rotavirus serum IgA response (defined as a ≥3 fold increase from baseline) 4 weeks after 3 doses of RV3-BB administered in an infant schedule at a high dose of vaccine will be assessed along with cumulative vaccine take and components of vaccine take after 3 doses of RV3-BB administered in a neonatal or infant schedule. The safety and tolerability of RV3-BB when administered as an infant or as a neonatal schedule will be described. ;

Study Design

Related Conditions & MeSH terms

Rotavirus Infections

Clinical Trial Details

NCT number	NCT03483116
Study type	Interventional
Source	Murdoch Childrens Research Institute
Contact
Status	Completed
Phase	Phase 2
Start date	June 15, 2018
Completion date	January 27, 2020

View Details

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