A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2007
A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process. The primary hypotheses tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to HBsAg that are non-inferior or superior to those induced by the current process vaccine.
Epistemonikos ID: c351def49deaee1d9a7b40692f3ab3bcfd63d807
First added on: Nov 24, 2021