Hepatitis B
Conditions
Keywords
Hepatitis B immunoglobulin, Hepatitis B antibody persistence
Brief summary
To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.
Detailed description
The primary study was to evaluate the reactogenicity, immunogenicity and protective efficacy of a hepatitis B vaccine in healthy neonates of HBeAg positive mothers if administered with or without a dose of HBIg at birth. The current study describes the long term follow up of these subjects between Y16 and 20 after primary vaccination.
Interventions
BIOLOGICALEngerix™ -B
3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study
BIOLOGICALHepatitis B immunoglobulin (HBIg)
1 intramuscular injections at birth (primary study)
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 20 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who had received at least one dose of the study vaccine in the primary study * Written informed consent obtained from each subject before each blood sampling visit
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | At Years 15, 16, 17, 18, 19 and 20 | Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL). Note: At Year 15 and 16, a commercial ELISA was used. From Year 17 to Year 20, anti-HBs antibody concentrations were tested with a validated in-house assay with cut-off 3.3mIU/mL. |
| Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA). | At Years 19 and 20 | Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL). Note: There was a change of assay kit at Year 19 time-point, thus for the sake of bridging, blood samples corresponding to Year 19 were re-tested with new CLIA. At Year 19 and 20, anti-HBs antibody concentrations tested with the CLIA with cut-off 6.2 mIU/mL. |
| Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | At Years 15, 16, 17, 18, 19 and 20 | Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL. |
| Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA) | At Years 19 and 20 | Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL. Note: Missing CLIA anti-HBs concentrations, for subjects with ELISA results available, are estimated by multiple imputations and GMCs and number of subjects were adjusted for these imputations. |
| Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | At Years 15, 16, 17, 18, 19 and 20 | Serological markers for hepatitis B infection assessed are hepatitis B surface antigen (HBsAg), antibodies to hepatitis B core antigen (anti-HBc), hepatitis B e antigen (HBeAg) and antibodies to hepatitis B e antigen (anti-HBe). |
| Number of Subjects With Different Hepatitis B Infection Statuses | Over the entire follow up period (Final assessment of clinical significance was analyzed after the Year 20 time point) | Categories hepatitis B (HB) infection: 1. Chronic infection: HBsAg and anti-HBc pos (pos) in more than two consecutive samples 2. False positive: single HB marker (HBsAg, HBeAg, anti-HBc) pos + all other markers negative (neg) in one sample. Consecutive time points all neg. 3. Possible subclinical breakthrough infection: One or more HB markers pos in one or more consecutive samples. 4. Isolated natural booster: \>4-fold increase of anti-HBs concentrations if \<100 mIU/mL at previous sample OR \>2- fold increase of anti-HBs concentrations if \>=100 mIU/mL at previous sample + other markers neg |
Countries
Thailand
Participant flow
Pre-assignment details
The baseline characteristics are given for the Year 15 time point. Therefore the number of participants in the Engerix-3D Group is 21, as in the Year 15 participant flow data.
Participants by arm
| Arm | Count |
|---|---|
| Engerix 4D + HBIg Group Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm. | 19 |
| Engerix 3D + HBIg Group Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm. | 19 |
| Engerix 4D Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60. | 14 |
| Engerix 3D Group Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6 | 21 |
| Total | 73 |
Baseline characteristics
| Characteristic | Engerix 4D + HBIg Group | Engerix 3D + HBIg Group | Engerix 4D | Engerix 3D Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 14.5 years STANDARD_DEVIATION 0.51 | 14.7 years STANDARD_DEVIATION 0.45 | 14.6 years STANDARD_DEVIATION 0.5 | 14.5 years STANDARD_DEVIATION 0.51 | 14.6 years STANDARD_DEVIATION 0.49 |
| Sex: Female, Male Female | 12 Participants | 7 Participants | 6 Participants | 10 Participants | 35 Participants |
| Sex: Female, Male Male | 7 Participants | 12 Participants | 8 Participants | 11 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA)
Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL. Note: Missing CLIA anti-HBs concentrations, for subjects with ELISA results available, are estimated by multiple imputations and GMCs and number of subjects were adjusted for these imputations.
Time frame: At Years 19 and 20
Population: Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Engerix 4D + HBIg Group | Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA) | Year 19 (≥ 1.0 mIU/mL) (N=14;12;6;11) | 13.0 Subjects |
| Engerix 4D + HBIg Group | Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA) | Year 19 (≥ 10 mIU/mL) (N=14;12;6;11) | 12.0 Subjects |
| Engerix 4D + HBIg Group | Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA) | Year 20 (≥ 1.0 mIU/mL) (N=16;13;7;13) | 13.1 Subjects |
| Engerix 4D + HBIg Group | Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA) | Year 20 (≥ 10 mIU/mL) (N=16;13;7;13) | 12.2 Subjects |
| Engerix 3D + HBIg Group | Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA) | Year 19 (≥ 10 mIU/mL) (N=14;12;6;11) | 3.9 Subjects |
| Engerix 3D + HBIg Group | Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA) | Year 20 (≥ 1.0 mIU/mL) (N=16;13;7;13) | 5.4 Subjects |
| Engerix 3D + HBIg Group | Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA) | Year 20 (≥ 10 mIU/mL) (N=16;13;7;13) | 2.1 Subjects |
| Engerix 3D + HBIg Group | Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA) | Year 19 (≥ 1.0 mIU/mL) (N=14;12;6;11) | 4.2 Subjects |
| Engerix 4D | Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA) | Year 20 (≥ 1.0 mIU/mL) (N=16;13;7;13) | 6.0 Subjects |
| Engerix 4D | Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA) | Year 19 (≥ 10 mIU/mL) (N=14;12;6;11) | 5.0 Subjects |
| Engerix 4D | Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA) | Year 20 (≥ 10 mIU/mL) (N=16;13;7;13) | 5.0 Subjects |
| Engerix 4D | Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA) | Year 19 (≥ 1.0 mIU/mL) (N=14;12;6;11) | 6.0 Subjects |
| Engerix 3D Group | Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA) | Year 20 (≥ 10 mIU/mL) (N=16;13;7;13) | 5.8 Subjects |
| Engerix 3D Group | Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA) | Year 19 (≥ 10 mIU/mL) (N=14;12;6;11) | 4.0 Subjects |
| Engerix 3D Group | Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA) | Year 19 (≥ 1.0 mIU/mL) (N=14;12;6;11) | 7.0 Subjects |
| Engerix 3D Group | Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA) | Year 20 (≥ 1.0 mIU/mL) (N=16;13;7;13) | 6.3 Subjects |
Primary
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA).
Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL). Note: There was a change of assay kit at Year 19 time-point, thus for the sake of bridging, blood samples corresponding to Year 19 were re-tested with new CLIA. At Year 19 and 20, anti-HBs antibody concentrations tested with the CLIA with cut-off 6.2 mIU/mL.
Time frame: At Years 19 and 20
Population: Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Engerix 4D + HBIg Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA). | YEAR 19 (N=14;12;6;11) | 60.1 mIU/mL |
| Engerix 4D + HBIg Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA). | YEAR 20 (N=16;13;7;13) | 44.0 mIU/mL |
| Engerix 3D + HBIg Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA). | YEAR 20 (N=16;13;7;13) | 5.1 mIU/mL |
| Engerix 3D + HBIg Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA). | YEAR 19 (N=14;12;6;11) | 5.8 mIU/mL |
| Engerix 4D | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA). | YEAR 20 (N=16;13;7;13) | 83.5 mIU/mL |
| Engerix 4D | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA). | YEAR 19 (N=14;12;6;11) | 159.0 mIU/mL |
| Engerix 3D Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA). | YEAR 20 (N=16;13;7;13) | 9.5 mIU/mL |
| Engerix 3D Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA). | YEAR 19 (N=14;12;6;11) | 11.7 mIU/mL |
Primary
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL). Note: At Year 15 and 16, a commercial ELISA was used. From Year 17 to Year 20, anti-HBs antibody concentrations were tested with a validated in-house assay with cut-off 3.3mIU/mL.
Time frame: At Years 15, 16, 17, 18, 19 and 20
Population: Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Engerix 4D + HBIg Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 15 (N=17;15;12;17) | 118.6 mIU/mL |
| Engerix 4D + HBIg Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 16 (N=15;13;12;16) | 119.3 mIU/mL |
| Engerix 4D + HBIg Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 17 (N=17;13;11;13) | 140.0 mIU/mL |
| Engerix 4D + HBIg Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 18 (N=14;14;10;13) | 82.3 mIU/mL |
| Engerix 4D + HBIg Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 19 (N=13;12;8;11) | 103.3 mIU/mL |
| Engerix 4D + HBIg Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 20 (N=13;13;6;12) | 73.9 mIU/mL |
| Engerix 3D + HBIg Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 20 (N=13;13;6;12) | 14.3 mIU/mL |
| Engerix 3D + HBIg Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 18 (N=14;14;10;13) | 10.8 mIU/mL |
| Engerix 3D + HBIg Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 15 (N=17;15;12;17) | 14.8 mIU/mL |
| Engerix 3D + HBIg Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 17 (N=17;13;11;13) | 8.2 mIU/mL |
| Engerix 3D + HBIg Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 16 (N=15;13;12;16) | 14.1 mIU/mL |
| Engerix 3D + HBIg Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 19 (N=13;12;8;11) | 9.5 mIU/mL |
| Engerix 4D | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 16 (N=15;13;12;16) | 134.3 mIU/mL |
| Engerix 4D | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 17 (N=17;13;11;13) | 70.2 mIU/mL |
| Engerix 4D | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 18 (N=14;14;10;13) | 56.5 mIU/mL |
| Engerix 4D | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 20 (N=13;13;6;12) | 297.1 mIU/mL |
| Engerix 4D | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 19 (N=13;12;8;11) | 84.9 mIU/mL |
| Engerix 4D | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 15 (N=17;15;12;17) | 142.8 mIU/mL |
| Engerix 3D Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 19 (N=13;12;8;11) | 19.9 mIU/mL |
| Engerix 3D Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 20 (N=13;13;6;12) | 16.3 mIU/mL |
| Engerix 3D Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 16 (N=15;13;12;16) | 22.9 mIU/mL |
| Engerix 3D Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 18 (N=14;14;10;13) | 26.1 mIU/mL |
| Engerix 3D Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 15 (N=17;15;12;17) | 24.2 mIU/mL |
| Engerix 3D Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Year 17 (N=17;13;11;13) | 17.0 mIU/mL |
Primary
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).
Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL.
Time frame: At Years 15, 16, 17, 18, 19 and 20
Population: Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Engerix 4D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 19 (≥ 10 mIU/mL) (N=14;12;8;11) | 12 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 20 (≥ 10 mIU/mL) (N=13;13;6;12) | 11 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 18 (≥ 10 mIU/mL) (N=14;14;10;13) | 13 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 15 (≥ 1.0 mIU/mL) (N=17;15;12;17) | 17 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 19 (≥ 1.0 mIU/mL) (N=14;12;8;11) | 13 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 16 (≥ 1.0 mIU/mL) (N=15;13;12;16) | 15 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 16 (≥ 10 mIU/mL) (N=15;13;12;16) | 14 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 15 (≥ 10 mIU/mL) (N=17;15;12;17) | 16 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 20 (≥ 1.0 mIU/mL) (N=13;13;6;12) | 13 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 17 (≥ 1.0 mIU/mL) (N=17;13;11;13) | 15 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 17 (≥ 10 mIU/mL) (N=17;13;11;13) | 15 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 18 (≥ 1.0 mIU/mL) (N=14;14;10;13) | 14 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 15 (≥ 10 mIU/mL) (N=17;15;12;17) | 4 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 18 (≥ 1.0 mIU/mL) (N=14;14;10;13) | 7 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 16 (≥ 10 mIU/mL) (N=15;13;12;16) | 6 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 19 (≥ 1.0 mIU/mL) (N=14;12;8;11) | 7 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 19 (≥ 10 mIU/mL) (N=14;12;8;11) | 3 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 18 (≥ 10 mIU/mL) (N=14;14;10;13) | 3 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 15 (≥ 1.0 mIU/mL) (N=17;15;12;17) | 7 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 17 (≥ 10 mIU/mL) (N=17;13;11;13) | 2 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 17 (≥ 1.0 mIU/mL) (N=17;13;11;13) | 7 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 16 (≥ 1.0 mIU/mL) (N=15;13;12;16) | 9 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 20 (≥ 10 mIU/mL) (N=13;13;6;12) | 5 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 20 (≥ 1.0 mIU/mL) (N=13;13;6;12) | 9 subjects |
| Engerix 4D | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 18 (≥ 10 mIU/mL) (N=14;14;10;13) | 7 subjects |
| Engerix 4D | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 15 (≥ 1.0 mIU/mL) (N=17;15;12;17) | 10 subjects |
| Engerix 4D | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 15 (≥ 10 mIU/mL) (N=17;15;12;17) | 9 subjects |
| Engerix 4D | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 16 (≥ 1.0 mIU/mL) (N=15;13;12;16) | 12 subjects |
| Engerix 4D | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 16 (≥ 10 mIU/mL) (N=15;13;12;16) | 10 subjects |
| Engerix 4D | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 17 (≥ 1.0 mIU/mL) (N=17;13;11;13) | 11 subjects |
| Engerix 4D | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 17 (≥ 10 mIU/mL) (N=17;13;11;13) | 9 subjects |
| Engerix 4D | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 18 (≥ 1.0 mIU/mL) (N=14;14;10;13) | 10 subjects |
| Engerix 4D | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 19 (≥ 1.0 mIU/mL) (N=14;12;8;11) | 8 subjects |
| Engerix 4D | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 19 (≥ 10 mIU/mL) (N=14;12;8;11) | 6 subjects |
| Engerix 4D | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 20 (≥ 1.0 mIU/mL) (N=13;13;6;12) | 5 subjects |
| Engerix 4D | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 20 (≥ 10 mIU/mL) (N=13;13;6;12) | 5 subjects |
| Engerix 3D Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 17 (≥ 10 mIU/mL) (N=17;13;11;13) | 5 subjects |
| Engerix 3D Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 17 (≥ 1.0 mIU/mL) (N=17;13;11;13) | 10 subjects |
| Engerix 3D Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 15 (≥ 1.0 mIU/mL) (N=17;15;12;17) | 11 subjects |
| Engerix 3D Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 19 (≥ 10 mIU/mL) (N=14;12;8;11) | 6 subjects |
| Engerix 3D Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 16 (≥ 10 mIU/mL) (N=15;13;12;16) | 8 subjects |
| Engerix 3D Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 16 (≥ 1.0 mIU/mL) (N=15;13;12;16) | 11 subjects |
| Engerix 3D Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 20 (≥ 10 mIU/mL) (N=13;13;6;12) | 6 subjects |
| Engerix 3D Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 20 (≥ 1.0 mIU/mL) (N=13;13;6;12) | 10 subjects |
| Engerix 3D Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 18 (≥ 10 mIU/mL) (N=14;14;10;13) | 7 subjects |
| Engerix 3D Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 18 (≥ 1.0 mIU/mL) (N=14;14;10;13) | 8 subjects |
| Engerix 3D Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 15 (≥ 10 mIU/mL) (N=17;15;12;17) | 7 subjects |
| Engerix 3D Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). | Year 19 (≥ 1.0 mIU/mL) (N=14;12;8;11) | 8 subjects |
Primary
Number of Subjects With Different Hepatitis B Infection Statuses
Categories hepatitis B (HB) infection: 1. Chronic infection: HBsAg and anti-HBc pos (pos) in more than two consecutive samples 2. False positive: single HB marker (HBsAg, HBeAg, anti-HBc) pos + all other markers negative (neg) in one sample. Consecutive time points all neg. 3. Possible subclinical breakthrough infection: One or more HB markers pos in one or more consecutive samples. 4. Isolated natural booster: \>4-fold increase of anti-HBs concentrations if \<100 mIU/mL at previous sample OR \>2- fold increase of anti-HBs concentrations if \>=100 mIU/mL at previous sample + other markers neg
Time frame: Over the entire follow up period (Final assessment of clinical significance was analyzed after the Year 20 time point)
Population: Analysis was performed on the Long Term Total Cohort (LT total cohort). The maximum amount of subjects who have participated in any of the time points in this study has been given as number of participants analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Engerix 4D + HBIg Group | Number of Subjects With Different Hepatitis B Infection Statuses | Isolated natural booster | 8 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Different Hepatitis B Infection Statuses | False positive | 5 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Different Hepatitis B Infection Statuses | Chronic HB infection | 0 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Different Hepatitis B Infection Statuses | Possible subclinical breakthrough HB infection | 9 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Different Hepatitis B Infection Statuses | False positive | 5 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Different Hepatitis B Infection Statuses | Possible subclinical breakthrough HB infection | 12 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Different Hepatitis B Infection Statuses | Chronic HB infection | 0 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Different Hepatitis B Infection Statuses | Isolated natural booster | 8 subjects |
| Engerix 4D | Number of Subjects With Different Hepatitis B Infection Statuses | Chronic HB infection | 0 subjects |
| Engerix 4D | Number of Subjects With Different Hepatitis B Infection Statuses | False positive | 9 subjects |
| Engerix 4D | Number of Subjects With Different Hepatitis B Infection Statuses | Possible subclinical breakthrough HB infection | 4 subjects |
| Engerix 4D | Number of Subjects With Different Hepatitis B Infection Statuses | Isolated natural booster | 9 subjects |
| Engerix 3D Group | Number of Subjects With Different Hepatitis B Infection Statuses | False positive | 10 subjects |
| Engerix 3D Group | Number of Subjects With Different Hepatitis B Infection Statuses | Chronic HB infection | 4 subjects |
| Engerix 3D Group | Number of Subjects With Different Hepatitis B Infection Statuses | Isolated natural booster | 7 subjects |
| Engerix 3D Group | Number of Subjects With Different Hepatitis B Infection Statuses | Possible subclinical breakthrough HB infection | 10 subjects |
Primary
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection
Serological markers for hepatitis B infection assessed are hepatitis B surface antigen (HBsAg), antibodies to hepatitis B core antigen (anti-HBc), hepatitis B e antigen (HBeAg) and antibodies to hepatitis B e antigen (anti-HBe).
Time frame: At Years 15, 16, 17, 18, 19 and 20
Population: Analysis was performed on the Long Term Total Cohort (LT total cohort) on subjects with available data for the specified marker.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 19 HBsAg (N=17;16;12;18) | 4 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 16 HBeAg (N=6;5;3;11) | 1 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 18 Anti-HBe (N=8;7;4;10) | 1 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 15 Anti-HBc (N=19;19;14;21) | 4 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 20 HBsAg (N=19;17;12;20) | 6 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 16 Anti-HBe (N=6;5;3;11) | 0 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 15 Anti-HBe (N=4;7;1;8) | 1 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 19 Anti-HBc (N=17;16;12;18) | 4 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 18 HBeAg (N=8;7;4;10) | 0 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 17 HBsAg (N=19;17;13;19) | 6 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 20 Anti-HBc (N=19;17;12;20) | 5 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 16 HBsAg (N=16;17;16;22) | 2 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 19 Anti-HBe (N=8;7;5;10) | 1 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 17 Anti-HBc (N=19;17;13;20) | 5 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 18 Anti-HBc (N=16;17;14;20) | 5 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 20 Anti-HBe (N=10;9;6;15) | 1 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 16 Anti-HBc (N=16;17;16;22) | 4 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 17 HBeAg (N=9;5;4;10) | 0 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 18 HBsAg (N=16;17;14;20) | 3 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 20 HBeAg (N=8;7;6;14) | 1 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 19 HBeAg (N=8;7;5;10) | 0 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 17 Anti-HBe (N=9;5;4;10) | 1 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 15 HBsAg (N=19;19;14;21) | 0 subjects |
| Engerix 4D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 15 HBeAg (N=4;7;1;8) | 0 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 16 Anti-HBe (N=6;5;3;11) | 1 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 18 HBsAg (N=16;17;14;20) | 1 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 15 HBeAg (N=4;7;1;8) | 1 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 18 Anti-HBc (N=16;17;14;20) | 6 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 19 HBsAg (N=17;16;12;18) | 3 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 18 HBeAg (N=8;7;4;10) | 0 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 20 Anti-HBc (N=19;17;12;20) | 7 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 18 Anti-HBe (N=8;7;4;10) | 1 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 15 Anti-HBe (N=4;7;1;8) | 1 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 15 Anti-HBc (N=19;19;14;21) | 7 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 16 HBsAg (N=16;17;16;22) | 0 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 16 Anti-HBc (N=16;17;16;22) | 5 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 20 HBsAg (N=19;17;12;20) | 5 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 16 HBeAg (N=6;5;3;11) | 1 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 15 HBsAg (N=19;19;14;21) | 1 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 19 Anti-HBc (N=17;16;12;18) | 5 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 20 Anti-HBe (N=10;9;6;15) | 0 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 19 Anti-HBe (N=8;7;5;10) | 1 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 17 HBsAg (N=19;17;13;19) | 0 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 20 HBeAg (N=8;7;6;14) | 0 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 17 Anti-HBc (N=19;17;13;20) | 5 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 19 HBeAg (N=8;7;5;10) | 0 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 17 HBeAg (N=9;5;4;10) | 0 subjects |
| Engerix 3D + HBIg Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 17 Anti-HBe (N=9;5;4;10) | 0 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 16 HBsAg (N=16;17;16;22) | 2 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 15 HBsAg (N=19;19;14;21) | 0 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 15 Anti-HBc (N=19;19;14;21) | 1 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 15 HBeAg (N=4;7;1;8) | 0 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 15 Anti-HBe (N=4;7;1;8) | 0 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 16 Anti-HBc (N=16;17;16;22) | 1 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 16 HBeAg (N=6;5;3;11) | 0 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 16 Anti-HBe (N=6;5;3;11) | 0 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 17 HBsAg (N=19;17;13;19) | 3 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 17 Anti-HBc (N=19;17;13;20) | 1 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 17 HBeAg (N=9;5;4;10) | 0 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 17 Anti-HBe (N=9;5;4;10) | 0 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 18 HBsAg (N=16;17;14;20) | 3 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 18 Anti-HBc (N=16;17;14;20) | 1 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 18 HBeAg (N=8;7;4;10) | 0 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 18 Anti-HBe (N=8;7;4;10) | 0 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 19 HBsAg (N=17;16;12;18) | 3 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 19 Anti-HBc (N=17;16;12;18) | 2 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 19 HBeAg (N=8;7;5;10) | 0 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 19 Anti-HBe (N=8;7;5;10) | 0 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 20 HBsAg (N=19;17;12;20) | 4 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 20 Anti-HBc (N=19;17;12;20) | 2 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 20 HBeAg (N=8;7;6;14) | 0 subjects |
| Engerix 4D | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 20 Anti-HBe (N=10;9;6;15) | 0 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 19 Anti-HBc (N=17;16;12;18) | 9 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 17 HBeAg (N=9;5;4;10) | 1 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 17 Anti-HBc (N=19;17;13;20) | 8 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 15 HBsAg (N=19;19;14;21) | 3 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 19 HBeAg (N=8;7;5;10) | 2 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 17 HBsAg (N=19;17;13;19) | 6 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 16 Anti-HBe (N=6;5;3;11) | 2 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 16 HBsAg (N=16;17;16;22) | 5 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 19 Anti-HBe (N=8;7;5;10) | 3 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 16 HBeAg (N=6;5;3;11) | 3 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 16 Anti-HBc (N=16;17;16;22) | 9 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 20 HBeAg (N=8;7;6;14) | 1 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 20 HBsAg (N=19;17;12;20) | 12 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 15 Anti-HBe (N=4;7;1;8) | 3 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 15 HBeAg (N=4;7;1;8) | 1 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 20 Anti-HBe (N=10;9;6;15) | 3 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 18 Anti-HBe (N=8;7;4;10) | 2 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 18 HBeAg (N=8;7;4;10) | 1 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 18 Anti-HBc (N=16;17;14;20) | 8 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 20 Anti-HBc (N=19;17;12;20) | 8 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 19 HBsAg (N=17;16;12;18) | 5 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 18 HBsAg (N=16;17;14;20) | 5 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 17 Anti-HBe (N=9;5;4;10) | 3 subjects |
| Engerix 3D Group | Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection | Year 15 Anti-HBc (N=19;19;14;21) | 9 subjects |