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This phase IV open study will evaluate the persistence of humoral antibodies against hepatitis B as well as the immune response to a challenge dose of hepatitis B vaccine in adolescents aged 12-13 years, who received three consecutive doses of GSK Biologicals' recombinant hepatitis B vaccine (Engerixâ„¢-B) in infancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Engerix-B Group | Experimental | Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engerixâ„¢-B Kinder | Biological | Intramuscular, one dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value | The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL). | One month after the challenge dose (Month 1) |
| Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ChemiLuminescence ImmunoAssay (CLIA) Equal to or Above Cut-off Value. | The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL). | One month after the challenge dose (Month 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values | The cut-off values were defined as 3.3 mIU/mL, 10 mIU/mL and 100 mIU/mL. Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure. | Before (Day 0) and one month (Month 1) after the challenge dose |
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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 | Ettenheim | Baden-Wurttemberg | 77955 | Germany | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22508412 | Derived | Behre U, Bleckmann G, Crasta PD, Leyssen M, Messier M, Jacquet JM, Hardt K. Long-term anti-HBs antibody persistence and immune memory in children and adolescents who received routine childhood hepatitis B vaccination. Hum Vaccin Immunother. 2012 Jun;8(6):813-8. doi: 10.4161/hv.19898. Epub 2012 Apr 17. |
| 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 |
|---|---|---|---|
| 112682 | Study Protocol | 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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| ID | Title | Description |
|---|---|---|
| FG000 | Engerix-B Group | Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values | The cut-off values were defined as 6.2 mIU/mL, 10 mIU/mL and 100 mIU/mL. Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure. | Before (Day 0) and one month (Month 1) after the challenge dose |
| Number of Subjects With Solicited Local and General Symptoms | Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever. Fever was defined as axillary temperature greater than or equal to 37.5 degrees Celsius. | During the 4-day (Day 0-3) follow-up period following the challenge dose vaccination |
| Number of Subjects With Unsolicited Adverse Events (AEs) | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | During the 31-day (Day 0-30) follow-up period following the challenge dose vaccination |
| Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | After the challenge dose of the vaccine (Day 0) up to the study end (Month 1) |
| Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by ELISA. | Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration equal to or greater than 3.3 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations less than 3.3 mIU/mL) at the pre-challenge dose time point. | One month after the challenge dose (Month 1) |
| Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by CLIA. | Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration ≥ 6.2 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations < 6.2 mIU/mL) at the pre-challenge dose time point. | One month after the challenge dose (Month 1) |
| Kehl |
| Baden-Wurttemberg |
| 77694 |
| Germany |
| GSK Investigational Site | Mannheim | Baden-Wurttemberg | 68163 | Germany |
| GSK Investigational Site | Pforzheim | Baden-Wurttemberg | 75172 | Germany |
| GSK Investigational Site | Schwäbisch Hall | Baden-Wurttemberg | 74523 | Germany |
| GSK Investigational Site | Stuttgart | Baden-Wurttemberg | 70469 | Germany |
| GSK Investigational Site | Tuttlingen | Baden-Wurttemberg | 78532 | Germany |
| GSK Investigational Site | Bindlach | Bavaria | 95463 | Germany |
| GSK Investigational Site | Cham | Bavaria | 93413 | Germany |
| GSK Investigational Site | Gilching | Bavaria | 82205 | Germany |
| GSK Investigational Site | Kempten (Allgäu) | Bavaria | 87435 | Germany |
| GSK Investigational Site | Kirchheim | Bavaria | 85551 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81375 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81735 | Germany |
| GSK Investigational Site | Nördlingen | Bavaria | 86720 | Germany |
| GSK Investigational Site | Braunatal | Hesse | 34225 | Germany |
| GSK Investigational Site | Duisburg | North Rhine-Westphalia | 47137 | Germany |
| GSK Investigational Site | Münster | North Rhine-Westphalia | 48163 | Germany |
| GSK Investigational Site | Frankenthal | Rhineland-Palatinate | 67227 | Germany |
| GSK Investigational Site | Worms | Rhineland-Palatinate | 67547 | Germany |
| GSK Investigational Site | Weimar | Thuringia | 99425 | Germany |
| GSK Investigational Site | Berlin | 10315 | Germany |
| GSK Investigational Site | Berlin | 10967 | Germany |
| GSK Investigational Site | Berlin | 13055 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 112682 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112682 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112682 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112682 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112682 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112682 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Engerix-B Group | Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value | The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL). | The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose. | Posted | Count of Participants | Participants | One month after the challenge dose (Month 1) |
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| Primary | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ChemiLuminescence ImmunoAssay (CLIA) Equal to or Above Cut-off Value. | The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL). | The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose. | Posted | Count of Participants | Participants | One month after the challenge dose (Month 1) |
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| Secondary | Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values | The cut-off values were defined as 3.3 mIU/mL, 10 mIU/mL and 100 mIU/mL. Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure. | The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose. | Posted | Count of Participants | Participants | Before (Day 0) and one month (Month 1) after the challenge dose |
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| Secondary | Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values | The cut-off values were defined as 6.2 mIU/mL, 10 mIU/mL and 100 mIU/mL. Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure. | The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose. | Posted | Count of Participants | Participants | Before (Day 0) and one month (Month 1) after the challenge dose |
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| Secondary | Number of Subjects With Solicited Local and General Symptoms | Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever. Fever was defined as axillary temperature greater than or equal to 37.5 degrees Celsius. | The analysis was performed on the Total Vaccinated cohort. | Posted | Count of Participants | Participants | During the 4-day (Day 0-3) follow-up period following the challenge dose vaccination |
|
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| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | The analysis was performed on the Total Vaccinated cohort. | Posted | Count of Participants | Participants | During the 31-day (Day 0-30) follow-up period following the challenge dose vaccination |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | The analysis was performed on the Total Vaccinated cohort. | Posted | Count of Participants | Participants | After the challenge dose of the vaccine (Day 0) up to the study end (Month 1) |
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| Secondary | Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by ELISA. | Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration equal to or greater than 3.3 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations less than 3.3 mIU/mL) at the pre-challenge dose time point. | The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose. | Posted | Count of Participants | Participants | One month after the challenge dose (Month 1) |
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| Secondary | Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by CLIA. | Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration ≥ 6.2 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations < 6.2 mIU/mL) at the pre-challenge dose time point. | The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose. | Posted | Count of Participants | Participants | One month after the challenge dose (Month 1) |
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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-B Group | Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0). | 0 | 306 | 170 | 306 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment |
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| Redness | General disorders | Systematic Assessment |
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| Swelling | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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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). The table shows updated results following complete retesting and reanalysis.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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