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Clinical Trial Summary

This is a phase 3 study, experimental, randomized, double blind, four arm parallel group study, lot to lot consistency.


Clinical Trial Description

This is a phase 3 study, experimental, randomized, double blind, four arm parallel group study, lot to lot consistency. The objective of the study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization, to assess the safety of In-House Recombinant Hepatitis B vaccine, to evaluate immunogenicity and safety in three consecutive batches of In-House Recombinant Hepatitis B vaccine and also evaluate immunogenicity and safety after primary series of investigational product compare to control. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05482295
Study type Interventional
Source PT Bio Farma
Contact Rini Mulia Sari, MD
Phone 0222033755
Email rini.mulia@biofarma.co.id
Status Not yet recruiting
Phase Phase 3
Start date October 2022
Completion date December 2022

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