Phase 3 N=204 Hepatitis B Challenge Dose in Adults (V232-059-10)
Hepatitis B
Primary: Percentage of Seroresponders Before and After the Challenge Vaccination — 45.5; 58.8; 85.2; 88.3 Percentage of participants
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Phase 3 N=100 Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® Compared to Engerix-B®
Hepatitis B
Primary: Seroconversion Rate — 47; 46 Participants — p=1
Phase 3 N=1,478 Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)
Hepatitis B
Primary: Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy — 323; 305 Participants — p=<0.001
Phase 4 N=182 Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults
Hepatitis B Vaccine
Primary: Number and Percentage of Participants With Anti-HBs Seroconversion at Month 7 — 75; 69 Participants
Phase 2 N=123 Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths
Hepatitis B
Primary: Qualitative Seroresponsiveness to Hepatitis B Surface Antigen — 41; 52; 6; 3 Participants — p=0.2954
Phase 4 N=352 Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients
Hepatitis B Vaccine
Primary: Anti-HBs Seroconversion Rate at Month 7 — 118; 132 Participants
Phase 4 N=76 Immune Response to Hepatitis B Vaccine Challenge Dose in Subjects Who Received a Primary Neonatal Hepatitis B Vaccine.
Hepatitis B
Primary: Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-off Values — 72; 71; 64 participants
Phase 3 N=277 Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)
Hepatitis B Virus Infection
Primary: The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7 — 49; 64 Participants
Phase 3 N=2,428 Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine
Hepatitis B
Primary: Percentage of Subjects With Seroprotective Immune Response — 95.1; 81.3 Percentage of Participants
Phase 1 N=20 Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg
Chronic Hepatitis B
Primary: Change in HBsAg Levels From Baseline to 2 Years — -0.27 log IU/ml — p=<0.05
Phase 4 N=371 Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth
HIV Infection · Hepatitis B
Primary: Sero-response to Hepatitis B Surface Antigen — 60; 73.2; 75.4 percentage of participants who resonded — p=0.0440
Phase 3 N=1,718 A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)
Hepatitis B
Primary: The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 μg and 10 μg Dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and…
Phase 4 N=300 Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.
Hepatitis B Vaccine
Primary: Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value — 275 Participants
Phase 3 N=8,374 Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine
Healthy
Primary: Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of…
Phase 3 N=540 Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)
Hepatitis B
Primary: The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine) — 115; 100 Participants
Phase 4 N=480 Immunogenicity of Hepatitis B Vaccination Among Drug Users
Hepatitis B Vaccination
Primary: Number and Rate of Participants With Anti-HBs Seroconversion at Month 7 — 142; 138; 0 Participants
Phase 4 N=196 Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
Hepatitis B Vaccine
Primary: Number and Rate of Participants With Anti-HBs Seroconversion at Month 7 — 59; 62 Participants
Phase 4 N=350 Hepatitis B Booster Study in Adolescence
Hepatitis B
Primary: Serum Anti-HBs Concentration 12 IU/L or Greater — 30; 76 Participants
Phase 2 N=378 Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating Chronic Hepatitis B Patients
Chronic Hepatitis B
Primary: Percentage of Participants With HBeAg Seroconversion at Week 48 — 21; 23 Participants
Phase 4 N=306 Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B Vaccination
Hepatitis B
Primary: Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value — 266 Participants
N/A N=127 The Hepatitis B Vaccine Booster Response Among the Youth Who Had Completed Neonatal Hepatitis B Vaccines
Hepatitis B
Primary: Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL) — 26; 96…
Phase 4 N=109 Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers
Hepatitis B
Primary: Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations — 87.6; 43.8; 143.4; 34.4 mIU/mL
Phase 1 N=61 Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B
Hepatitis B
Primary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs) — 9; 3; 7; 7 Participants
Phase 2 N=16 Adefovir Plus Vaccination in Transplant Patients Without Hepatitis B That Receive a Core Antibody Positive Liver
Hepatitis B · Liver Transplantation
Primary: Development of de Novo Hepatitis B Infection After Transplant With a Core Antibody Positive Liver — 5 Participants
Phase 4 N=67 Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines
Hepatitis B · Hepatitis · Hepatitis, Viral, Human
Primary: Number of Participants With Protective Levels of Antibodies After Treatment — 63; 4 Participants
Phase 2 N=207 Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine
Hepatitis B
Primary: Percentage of Participants With Local and Systemic Post-injection Reaction Rates — 38.2; 37.9; 37.2; 33.0 percentage of subjects
Phase 3 N=2,452 Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
Healthy
Primary: Percentage of Subjects Who Have a Seroprotective Immune Response — 90.1; 70.5 Percentage of participants
Phase 4 N=297 Hepatitis B Antibody Persistence and Immune Response to Hepatitis B Vaccine Challenge in Previously Vaccinated Children
Hepatitis B
Primary: Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL) — 251 Participants
Phase 3 N=638 B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B
HIV Infection · Hepatitis B
Primary: Percentage of Participants With Primary Seroprotection Response — 93.1; 99.4; 80.6; 100 percentage of participants
Phase 4 N=36 Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)
Hepatitis B
Primary: Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies — 0; 22; 2; 21 subjects