| Outcome Measures: |
Primary: Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest, Proportion of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations., Week 0 (Visit 1) until Week 68 or early termination|Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response, SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit \[mIU\]/mL) after HEPLISAV-B, Week 20 | Secondary: Percentage of Subjects With Anti-HBs Concentration ≥100 mIU/mL, Percentage of subjects with anti-HBs concentration ≥100 mIU/mL., Weeks 4, 8, 16, 20|Serum Anti-HBsAg Geometric Mean Concentration (GMC), Serum Anti-HBsAg Geometric Mean Concentration (GMC)., Weeks 4, 8, 16, 20|Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response, SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit \[mIU\]/mL) after HEPLISAV-B, Weeks 4, 8, 16, 20
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| Locations: |
DaVita Clinical Research or Affiliate, Bloomfield, Connecticut, 06002, United States|DaVita Clinical Research or Affiliate, Middlebury, Connecticut, 06762, United States|DaVita Clinical Research or Affiliate, Hollywood, Florida, 33021, United States|DaVita Clinical Research or Affiliate, Ocala, Florida, 34471, United States|DaVita Clinical Research or Affiliate, Tampa, Florida, 33614, United States|DaVita Clinical Research or Affiliate, Winter Park, Florida, 32789, United States|DaVita Clinical Research or Affiliate, Jeffersonville, Indiana, 47130, United States|DaVita Clinical Research or Affiliate, Roseville, Michigan, 48066, United States|DaVita Clinical Research or Affiliate, Edina, Minnesota, 55435, United States|DaVita Clinical Research or Affiliate, Minneapolis, Minnesota, 55404, United States|DaVita Clinical Research or Affiliate, Kansas City, Missouri, 64111, United States|DaVita Clinical Research or Affiliate, Las Vegas, Nevada, 89106, United States|DaVita Clinical Research or Affiliate, Bronx, New York, 10461, United States|DaVita Clinical Research or Affiliate, Asheville, North Carolina, 28801, United States|DaVita Clinical Research or Affiliate, Canton, Ohio, 44718, United States|DaVita Clinical Research or Affiliate, Philadelphia, Pennsylvania, 19106, United States|DaVita Clinical Research or Affiliate, El Paso, Texas, 79902, United States|DaVita Clinical Research or Affiliate, San Antonio, Texas, 78229, United States|DaVita Clinical Research or Affiliate, Norfolk, Virginia, 23510, United States|DaVita Clinical Research or Affiliate, Milwaukee, Wisconsin, 53227, United States
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