CASE STUDY Vaccine and Regional Knowledge Critical to Rescue of Hepatitis B Vaccine StudyRegions Western Europe South Korea STUDY DESCRIPTION Phase I, randomized, double-blind, placebo-controlled, multicenter, ascending-dose trial to evaluate the safety, tolerability, and immunogenicity of the study vaccine in hepatitis B e-antigen (HBeAg)-negative hepatitis B patients as a supplemental treatment to entecavir or tenofovir. Vaccine and Regional Knowledge Critical to Rescue of Hepatitis B Vaccine Study Business Segments Product Registration Services Scientific and Medical Affairs Primary Endpoint: • Solicited adverse events (AEs) related to injection site tolerability during the week following each vaccine administration • Unsolicited AEs through day 85 • Serious adverse even

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