Vaccine Reaction Clinical Trial
Official title:
Immunogenicity and Safety Following In-House Recombinant Hepatitis B (Bio Farma) Vaccine Compared to Hepatitis B (Bio Farma)® Vaccine in Indonesian Population
This is a phase 3 study, experimental, randomized, double blind, four arm parallel group study, lot to lot consistency. The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.
This is a phase 3 study, experimental, randomized, double blind, four arm parallel group study, lot to lot consistency. Total of 540 subjects aged 10-40 years old will be involved in this study. The subject will be divided into 4 groups, 3 groups are the investigational group and 1 group are the active comparator group. Each group consist of 135 subjects. 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. ;
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