Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00697840 | Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B | PHASE3 | COMPLETED | 150 | — | — | Jun 1, 1995 | Jan 1, 1996 | Jun 16, 2008 | 1 | Austria |
| NCT00697242 | Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults | PHASE3 | COMPLETED | 362 | — | — | Jan 1, 1994 | Nov 1, 1995 | Jun 13, 2008 | 4 | Austria, Belgium +2 |
| NCT00697970 | Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine | PHASE3 | COMPLETED | 321 | — | — | Nov 1, 1993 | Apr 1, 1995 | Jun 16, 2008 | 1 | Austria |
| NCT00805389 | Study to Compare the Efficacy of GSK Biologicals' Adjuvants in Combination With the Antigen of the Hepatitis B Vaccine | PHASE2 | COMPLETED | 713 | — | — | Dec 15, 2008 | Jul 14, 2011 | Aug 20, 2018 | 14 | Belgium, Germany |
| NCT00697853 | Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults | PHASE2 | COMPLETED | 200 | — | — | Nov 1, 1998 | - | Jun 16, 2008 | 1 | Belgium |
| NCT00697125 | Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants | PHASE2 | COMPLETED | 60 | — | — | Jun 1, 1993 | Jul 1, 1994 | Jun 13, 2008 | 1 | Belgium |
| NCT00697229 | Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules | PHASE2 | COMPLETED | 99 | — | — | Sep 1, 1992 | Dec 1, 1998 | Jun 13, 2008 | 1 | Belgium |
The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). Results for the Day 44 time point are the primary results among the outcome measure results presented.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | - |
| Group B | ACTIVE_COMPARATOR | - |
| Group C | EXPERIMENTAL | - |
| Group D | ACTIVE_COMPARATOR | - |
| Group E | EXPERIMENTAL | - |
| Group F | ACTIVE_COMPARATOR | - |
| GSK223192A 1 Group | EXPERIMENTAL | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| GSK223192A 2 Group | EXPERIMENTAL | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| GSK223192A 3 Group | EXPERIMENTAL | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| Fendrix Group | EXPERIMENTAL | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| Engerix-B Group | ACTIVE_COMPARATOR | Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm. |
| Group G | EXPERIMENTAL | Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of HBV-MPL vaccine at 70 months |
| Group H | EXPERIMENTAL | Subjects will receive Engerix™-B vaccine in the primary schedule 0, 6 months and will receive a booster dose of Engerix™-B vaccine at 70 months |
| Name | Type | Description |
|---|---|---|
| Engerix™-B | BIOLOGICAL | Intramuscular injection, 2 doses |
| HBV-MPL 208129 | BIOLOGICAL | Intramuscular injection, 2 doses |
| Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation | BIOLOGICAL | Intramuscular injection, 2 doses; experimental formulation |
| Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL | BIOLOGICAL | Intramuscular injection, 3 doses |
| HBsAg formulated with different concentrations of MPL and Aluminium Salts | BIOLOGICAL | Intramuscular injection, 3 doses |
| Engerix-B™ | BIOLOGICAL | 2 doses intramuscular injections |
| Fendrix™ | BIOLOGICAL | 2 doses intramuscular injections |
| GSK Biologicals' Hepatitis B vaccines (GSK223192A) | BIOLOGICAL | 2 doses intramuscular injections 3 different formulations of (GSK223192A), each administered to 1 group |
| HBsAg (Booster injection) | BIOLOGICAL | Single dose intramuscular injection |
| HBV-MPL vaccine 208129 | BIOLOGICAL | 2-dose intramuscular injection |
| HBV-MPL vaccine (208129) | BIOLOGICAL | - |
| Hepatitis B vaccine, experimental formulation | BIOLOGICAL | Intramuscular injection, 3 doses |
| HBV-MPL vaccine | BIOLOGICAL | Intramuscular injection, 1 or 3 doses |
Inclusion Criteria: * Between 18 and 40 years old. * Written informed consent will have been obtained from the subjects. * Good physical condition as established by physical examination and history taking at the time of entry. * Female participants will avoid becoming pregnant during the study peri...