Phase 4 N=251 A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children
Hepatitis A
Primary: Seroprotection at Month 1 — 95.9; 96.6 percentage of participants
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=19 Hepatitis A Vaccine Dosing Regimens Among Pediatric Patients on Immunosuppressive Therapy
Autoimmune Rheumatologic Disease
Primary: Hepatitis A Antibodies Titre — 9.4; 9.0; 394.7; 810.6 IU/L
Phase 4 N=28 Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human)
Anti-Hepatitis A Antibody Levels in Heathy Subjects
Primary: Percentage of Subjects Maintaining Protective Anti- HAV Antibody Levels — 26 Participants
Phase 3 N=244 Long-Term Follow-Up Studies at Year 6, 7, 8, 9, 10: 2 Formulations of Combined Hepatitis A/B Vaccine Compared in Subjects Aged 12-15 Years
Hepatitis B · Hepatitis A
Primary: Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value — 113; 100; 105; 92 subjects
Phase 4 N=78 Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine, Injected According to 0, 6-month Schedule
Hepatitis A
Primary: Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration — 593.6; 297.4; 363.2; 287.7 mIU/mL
Phase 3 N=252 Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine
Meningococcal Disease · Meningococcal Meningitis · Hepatitis A
Primary: Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination — 48; 30; 786; 884 Concentrations (mIU/mL)
N/A N=600 This Study Will Evaluate the Persistence of Hepatitis A Antibodies, 8 Years and 10 Years Later, in Children Who Had Received Havrix at Selected Health Centres of Panama
Hepatitis A Vaccine
Primary: Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose — 223; 293; 77; 7 Participants
Phase 3 N=1,241 Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children
Hepatitis A
Primary: Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups. — 1390.4; 1895.2 mIU/mL
Phase 4 N=653 Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067)
Hepatitis A Virus
Primary: Antibody Response to Hepatitis A - Participants With a Serological Response — 182; 158 Participants — p=<0.001
Phase 4 N=107 Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule
Hepatitis A
Primary: Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration — 748.1; 378.6; 419.3; 342.2 mIU/mL
Phase 4 N=1,800 Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)
Hepatitis A · Measles · Mumps
Primary: Participants With 1 or More Serious Vaccine-Related Adverse Experiences — 0; 1 participants
Phase 1 N=25 Safety Study of Hepatitis E Vaccine (HEV239)
Hepatitis E · Immunisation
Primary: Number of Participants With Solicited Local Reactogenicity Events — 11; 3; 17; 1 Participants
Phase 3 N=276 Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared
Hepatitis B · Hepatitis A
Primary: Anti-hepatitis A (HAV) Antibody Concentrations — 1122.2; 1377.8; 998.6; 1347.1 mIU/mL
Phase 3 N=37 Long-term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Mth Schedule in Healthy Adults
Hepatitis B · Hepatitis A
Primary: Number of Subjects With Anti-hepatitis A (Anti-HAV) Antibody Concentrations Equal to or Above Cut-off Value — 25; 28; 23; 24 Participants
Phase 4 N=49 Long-term Persistence Study in Healthy Adults Previously Vaccinated With Twinrix Adult
Hepatitis A · Hepatitis B
Primary: Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody…
Phase 3 N=433 Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age
Hepatitis A
Primary: Number of Seropositive Subjects for Anti-HAV Antibodies — 106; 94 Participants
Phase 3 N=51 Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule
Hepatitis B · Hepatitis A
Primary: Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration — 369.1; 323.5; 293.7; 298.2 mIU/mL
Phase 2 N=2,000 A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal.
Hepatitis
Primary: Percent of Participants of Definite Hepatitis E by Category and Immunological Markers (Anti HEV) During the Follow-up Period — 0.0; 6.9; 0.3; 0.1 Percent of Participants
N/A N=366 Undiagnosed Hepatitis C Infection in an Urban Hospital
Hepatitis C
Primary: Point Prevalence of Hepatitis C Infection — 9 percentage of total subjects
Phase 3 N=178 Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule
Hepatitis B · Hepatitis A
Primary: Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration — 692.3; 753.6; 544.4; 479.5 milli-international units per milliliter
Phase 3 N=900 Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Co-administered With an Hepatitis A Virus Vaccine
Healthy Volunteers
Primary: Percentage of Participants HAV/Dengue Virus (DENV)-Naive at Baseline Who Are Seroprotected Against HAV at Day 30 — 97.1; 9.1; 98.7 percentage of participants
Phase 4 N=40 Antibody Persistence & Immune Memory in Healthy Adults Previously Vaccinated With Twinrix Adult
Hepatitis A · Hepatitis B
Primary: Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody…
Phase 3 N=394 Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months
Hepatitis A
Primary: Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix — 88; 84; 77 Participants
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=475 A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Chronic Hepatitis B Patients )
Hepatitis E
Primary: Number of Participants Whose Anti-HEV Antibody Seroconverted at One Month After The Third Dose — 188; 196 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 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 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 2 N=19 Herpes Simplex Type 1 Suppression in Hepatitis C
Chronic Hepatitis C Infection
Primary: Change in HCV RNA Viral Load — .24; .08 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