NCT04185545

Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates

Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates, Lot to Lot Consistency and Antigen Interference With Co-Administered EPI Vaccines (Phase III)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,400 (actual)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 1 Minute – 5 Days
• Healthy volunteers: Accepted

Summary

This phase III trial aims to assess the efficacy, safety and immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in neonates, lot-to-lot consistency, and antigen interference with co-administered EPI vaccines

Detailed description

This study is a randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and immunogenicity following three doses of rotavirus RV3 vaccine (Bio Farma) administered as a neonatal schedule

Conditions

• Rotavirus Gastroenteritis

Interventions

Type	Name	Description
BIOLOGICAL	Rotavirus RV3 Vaccine (Bio Farma)	Each 1 mL dose of the final product of oral liquid rotavirus vaccine contains \> 5x10\^6 fcfu/mL rotavirus vaccine strain RV3
OTHER	Placebo	Each 1 mL dose of placebo contains 30% of sucrose in DMEM

Timeline

• Start date: 2020-10-30
• Primary completion: 2022-04-30
• Completion: 2023-05-30
• First posted: 2019-12-04
• Last updated: 2023-11-29

Locations

21 sites across 1 country: Indonesia