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
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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 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 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 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 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
N/A N=743 Prevalence of HBV in Pregnant Women Attending Antenatal Care in Tanzania
Hepatitis B
Primary: HBsAG Prevalence — 22 Participants
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=21 Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection
Hepatitis B
Primary: Change of Serum Hepatitis B Surface Antigen (HBsAg as Measured in log10 IU/mL) Level as an Indicator of Antiviral Activity of Ledipasvir and/or Sofosbuvir in Subjects…
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
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 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=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 4 N=179 Arresting Vertical Transmission of Hepatitis B Virus
Hepatitis B · Vertical Transmission of Infectious Disease
Primary: Number of Participants With Lab Testing Acceptability Survey Scores >80% — 7; 41; 7; 40 Participants
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 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
Phase 4 N=39 A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B
Hepatitis B, Chronic
Primary: Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter…
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 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
N/A N=149 The Relationship Between Vitamin D and Hepatitis B Virus Replication
Vitamin D and Hepatitis B Virus
Primary: The Dynamic Change of HBV DNA — 3.15; 3.14 IU/mL
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=352 Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients
Hepatitis B Vaccine
Primary: Anti-HBs Seroconversion Rate at Month 7 — 118; 132 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 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=73 LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers
Hepatitis B
Primary: Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). — 118.6; 14.8; 142.8; 24.2 mIU/mL
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 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
N/A N=160 Study of Telbivudine in Chronic Hepatitis B
Chronic Hepatitis B
Primary: HBV-DNA < 300 Copies/mL in 48 Weeks — 79 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=654 Maternal Antiviral Prophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus in Thailand
Hepatitis B Chronic Infection · Pregnancy
Primary: Percentage of Infants With Hepatitis B Infection at 6 Months of Age — 0; 3 Participants