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A Phase IIb, double-blind, randomised, placebo-controlled parallel group study of the efficacy, safety and immunogenicity of oral RV3-BB Rotavirus Vaccine, administered as a neonatal schedule with birth (age 0-5 days) dose, 8-10 and 14-16 week doses or an infant schedule of 8-10 ,14-16 and 18-20 week doses.

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Trial Profile

A Phase IIb, double-blind, randomised, placebo-controlled parallel group study of the efficacy, safety and immunogenicity of oral RV3-BB Rotavirus Vaccine, administered as a neonatal schedule with birth (age 0-5 days) dose, 8-10 and 14-16 week doses or an infant schedule of 8-10 ,14-16 and 18-20 week doses.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 23 Aug 2023

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At a glance

  • Drugs Rotavirus vaccine Bio Farma/Murdoch Childrens Research Institute (Primary)
  • Indications Rotavirus infections
  • Focus Therapeutic Use
  • Sponsors Biofarma

    • Most Recent Events

    • 18 Aug 2023 Results of (n=164) observational study of RV3-BB vaccine in Indonesian infants regardless of HBGA status, published in the Journal of Infectious Diseases
    • 09 Mar 2020 Results (n=233) of observational study conducted in immunogenicity sub-study of the Phase IIb RV3-BB vaccine clinical trial were published in the Vaccine
    • 24 Apr 2018 Results presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases

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