NCT03483116

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

A Phase II Randomized, Double Blind, Parallel Group Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine Administered at a High, Mid and Low Titre as a 3 Dose Neonate Schedule or Administered at a High Titre as a 3 Dose Infant Schedule.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 711 (actual)
• Sponsor: Murdoch Childrens Research Institute · Academic / Other
• Sex: All
• Age: 0 Days – 18 Weeks
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Rotavirus Infections

Interventions

Type	Name	Description
BIOLOGICAL	RV3-BB	Oral administration
BIOLOGICAL	Placebo	Oral administration

Timeline

• Start date: 2018-06-15
• Primary completion: 2020-01-27
• Completion: 2020-01-27
• First posted: 2018-03-30
• Last updated: 2023-07-10
• Results posted: 2023-07-10

Locations

1 site across 1 country: Malawi

Regulatory

• FDA-regulated drug study