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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Engerix 4D + HBIg Group | Experimental | Subjects received Engerixâ„¢ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm. |
|
| Engerix 3D + HBIg Group | Experimental | Subjects received Engerixâ„¢ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm. |
|
| Engerix 4D | Experimental | Subjects received Engerixâ„¢ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60. |
|
| Engerix 3D Group | Experimental | Subjects received Engerixâ„¢ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engerixâ„¢ -B | Biological | 3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Years 15, 16, 17, 18, 19 and 20 |
| 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. | At Years 19 and 20 |
| 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. | At Years 15, 16, 17, 18, 19 and 20 |
| 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. | At Years 19 and 20 |
| Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22777097 | Derived | Poovorawan Y, Chongsrisawat V, Theamboonlers A, Leroux-Roels G, Crasta PD, Hardt K. Persistence and immune memory to hepatitis B vaccine 20 years after primary vaccination of Thai infants, born to HBsAg and HBeAg positive mothers. Hum Vaccin Immunother. 2012 Jul;8(7):896-904. doi: 10.4161/hv.19989. Epub 2012 Jul 1. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 100450 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Engerix 4D + HBIg Group | Subjects received Engerixâ„¢ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm. |
| FG001 | Engerix 3D + HBIg Group | Subjects received Engerixâ„¢ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm. |
| FG002 | Engerix 4D | Subjects received Engerixâ„¢ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60. |
| FG003 | Engerix 3D Group | Subjects received Engerixâ„¢ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year 15 |
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| Year 16 |
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| Year 17 |
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| Year 18 |
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| Year 19 |
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| Year 20 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Engerix 4D + HBIg Group | Subjects received Engerixâ„¢ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm. |
| BG001 | Engerix 3D + HBIg Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data are given for the Year 15 time point. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Years 15, 16, 17, 18, 19 and 20 |
|
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As no adverse events data were collected during this study the number of participants at risk is 0 for all groups.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Engerix 4D + HBIg Group | Subjects received Engerixâ„¢ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm. |
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A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Additional tables have been generated following partial retesting and reanalysis of the results at Years 19 and 20.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| C045213 | hepatitis B hyperimmune globulin |
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| Hepatitis B immunoglobulin (HBIg) | Biological | 1 intramuscular injections at birth (primary study) |
|
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). |
| At Years 15, 16, 17, 18, 19 and 20 |
| Number of Subjects With Different Hepatitis B Infection Statuses | Categories hepatitis B (HB) infection:
| Over the entire follow up period (Final assessment of clinical significance was analyzed after the Year 20 time point) |
For additional information about this study please refer to the GSK Clinical Study Register |
| 100450 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100450 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100450 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100450 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100450 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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Subjects received Engerixâ„¢ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm. |
| BG002 | Engerix 4D | Subjects received Engerixâ„¢ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60. |
| BG003 | Engerix 3D Group | Subjects received Engerixâ„¢ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Engerix 3D + HBIg Group | Subjects received Engerixâ„¢ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm. |
| OG002 | Engerix 4D | Subjects received Engerixâ„¢ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60. |
| OG003 | Engerix 3D Group | Subjects received Engerixâ„¢ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 |
|
|
| 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. | 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 | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Years 19 and 20 |
|
|
|
| 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. | 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 | Posted | Number | subjects | At Years 15, 16, 17, 18, 19 and 20 |
|
|
|
| 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. | 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 | Posted | Number | Subjects | At Years 19 and 20 |
|
|
|
| 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). | Analysis was performed on the Long Term Total Cohort (LT total cohort) on subjects with available data for the specified marker. | Posted | Number | subjects | At Years 15, 16, 17, 18, 19 and 20 |
|
|
|
| Primary | Number of Subjects With Different Hepatitis B Infection Statuses | Categories hepatitis B (HB) infection:
| 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. | Posted | Number | subjects | Over the entire follow up period (Final assessment of clinical significance was analyzed after the Year 20 time point) |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Engerix 3D + HBIg Group | Subjects received Engerixâ„¢ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm. | 0 | 0 | 0 | 0 |
| EG002 | Engerix 4D | Subjects received Engerixâ„¢ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60. | 0 | 0 | 0 | 0 |
| EG003 | Engerix 3D Group | Subjects received Engerixâ„¢ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 | 0 | 0 | 0 | 0 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| YEAR 20 (N=16;13;7;13) |
|
| Year 15 (≥ 10 mIU/mL) (N=17;15;12;17) |
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| Year 16 (≥ 1.0 mIU/mL) (N=15;13;12;16) |
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| Year 16 (≥ 10 mIU/mL) (N=15;13;12;16) |
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| Year 17 (≥ 1.0 mIU/mL) (N=17;13;11;13) |
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| Year 17 (≥ 10 mIU/mL) (N=17;13;11;13) |
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| Year 18 (≥ 1.0 mIU/mL) (N=14;14;10;13) |
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| Year 18 (≥ 10 mIU/mL) (N=14;14;10;13) |
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| Year 19 (≥ 1.0 mIU/mL) (N=14;12;8;11) |
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| Year 19 (≥ 10 mIU/mL) (N=14;12;8;11) |
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| Year 20 (≥ 1.0 mIU/mL) (N=13;13;6;12) |
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| Year 20 (≥ 10 mIU/mL) (N=13;13;6;12) |
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| Year 19 (≥ 10 mIU/mL) (N=14;12;6;11) |
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| Year 20 (≥ 1.0 mIU/mL) (N=16;13;7;13) |
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| Year 20 (≥ 10 mIU/mL) (N=16;13;7;13) |
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| Year 15 Anti-HBc (N=19;19;14;21) |
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| Year 15 HBeAg (N=4;7;1;8) |
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| Year 15 Anti-HBe (N=4;7;1;8) |
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| Year 16 HBsAg (N=16;17;16;22) |
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| Year 16 Anti-HBc (N=16;17;16;22) |
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| Year 16 HBeAg (N=6;5;3;11) |
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| Year 16 Anti-HBe (N=6;5;3;11) |
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| Year 17 HBsAg (N=19;17;13;19) |
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| Year 17 Anti-HBc (N=19;17;13;20) |
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| Year 17 HBeAg (N=9;5;4;10) |
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| Year 17 Anti-HBe (N=9;5;4;10) |
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| Year 18 HBsAg (N=16;17;14;20) |
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| Year 18 Anti-HBc (N=16;17;14;20) |
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| Year 18 HBeAg (N=8;7;4;10) |
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| Year 18 Anti-HBe (N=8;7;4;10) |
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| Year 19 HBsAg (N=17;16;12;18) |
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| Year 19 Anti-HBc (N=17;16;12;18) |
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| Year 19 HBeAg (N=8;7;5;10) |
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| Year 19 Anti-HBe (N=8;7;5;10) |
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| Year 20 HBsAg (N=19;17;12;20) |
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| Year 20 Anti-HBc (N=19;17;12;20) |
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| Year 20 HBeAg (N=8;7;6;14) |
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| Year 20 Anti-HBe (N=10;9;6;15) |
|
| False positive |
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| Possible subclinical breakthrough HB infection |
|
| Isolated natural booster |
|