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| ID | Type | Description | Link |
|---|---|---|---|
| 100567 | Other Identifier | GSK | |
| 100568 | Other Identifier | GSK | |
| 100569 | Other Identifier | GSK | |
| 100570 | Other Identifier | GSK |
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To evaluate the persistence of anti-hepatitis A virus (anti-HAV) and anti-hepatitis B surface antigen (anti-HBs) antibodies up to 6, 7, 8, 9 and 10 years after administration of the first dose of the study vaccine.
Open, randomized, long-term antibody persistence studies. Immune persistence was compared between subjects who received one of the two formulations of GlaxoSmithKline Biologicals' combined hepatitis A and hepatitis B vaccine according to a two-dose or three-dose schedule. These long-term follow-up studies involved taking blood samples at approximately 6, 7, 8, 9 and 10 years after the primary vaccination of combined hepatitis A and B vaccine, to assess antibody persistence and a retrospective safety follow-up.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Twinrix Adult | Active Comparator | Subjects received Twinrixâ„¢ Adult (720/20) in a 0, 6 month schedule in the primary study. |
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| Group Twinrix Junior | Active Comparator | Subjects received Twinrixâ„¢ Junior (360/10) in a 0, 1, 6 month schedule in the primary study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Twinrixâ„¢ Adult | Biological | Intramuscular administration in the deltoid region (2 doses). |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value | Anti-HAV antibody concentration cut-off value assessed was ≥ 15 milli-International Units per milliliter (mIU/mL). | Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination |
| Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value | Anti-HBs antibody concentration cut-off value assessed was ≥ 3.3 mIU/mL. | Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination |
| Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling) | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. | From Year 6 through to Year 10 |
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Inclusion Criteria:
Exclusion Criteria:
• none
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Brussels | 1200 | Belgium | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20637766 | Background | Beran J, Kervyn D, Wertzova V, Hobzova L, Tichy P, Kuriyakose S, Leyssen M, Jacquet JM. Comparison of long-term (10 years) immunogenicity of two- and three-dose regimens of a combined hepatitis A and B vaccine in adolescents. Vaccine. 2010 Aug 23;28(37):5993-7. doi: 10.1016/j.vaccine.2010.06.104. Epub 2010 Jul 15. |
| 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 |
|---|---|---|---|
| 100566 | Individual Participant Data Set | 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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At the time of initiation of the long-term follow-up study, the investigators contacted the subjects who had consented to participate in the long-term follow-up studies. At each subsequent visit, subjects who were present at the previous long-term blood sampling time points were contacted again.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group Twinrix Junior | Subjects received Twinrixâ„¢ Junior (360/10) in a 0, 1, 6 month schedule in the primary study. |
| FG001 | Group Twinrix Adult | Subjects received Twinrixâ„¢ Adult (720/20) in a 0, 6 month schedule in the primary study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Year 6 |
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| Twinrixâ„¢ Junior | Biological | Intramuscular administration in the deltoid region (3 doses). |
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| Hradec Králové |
| 500 03 |
| Czechia |
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 100566 are summarised with studies 100567, 100568, 100569, and 100570 on the GSK Clinical Study Register. |
| 100566 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100566 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100566 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100566 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100566 | Statistical Analysis Plan | 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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| Year 7 |
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| Year 8 |
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| Year 9 |
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| Year 10 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group Twinrix Junior | Subjects received Twinrixâ„¢ Junior (360/10) in a 0, 1, 6 month schedule in the primary study. |
| BG001 | Group Twinrix Adult | Subjects received Twinrixâ„¢ Adult (720/20) in a 0, 6 month schedule in the primary study. |
| BG002 | Total | Total of all reporting groups |
| 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 | Subjects' mean age at Year 6, the time of first enrollment into the long-term follow-up phase of the study. | Mean | Standard Deviation | years |
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| 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 A Virus (HAV) Antibody Concentrations Above the Cut-off Value | Anti-HAV antibody concentration cut-off value assessed was ≥ 15 milli-International Units per milliliter (mIU/mL). | Analysis was performed on the Long Term According To Protocol (ATP) cohort for immunogenicity, which included all subjects for whom serology results were available for a particular blood sampling visit. | Posted | Number | subjects | Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination |
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| Primary | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value | Anti-HBs antibody concentration cut-off value assessed was ≥ 3.3 mIU/mL. | Analysis was performed on the ATP cohort for immunogenicity, which included all subjects for whom serology results were available for a particular blood sampling visit. | Posted | Number | subjects | Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination |
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| Primary | Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling) | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. | Posted | Number | subjects | From Year 6 through to Year 10 |
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From Year 6 through to Year 10.
Other (non-serious) adverse event data was not collected during this long-term follow-up phase of the study.
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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 | Group Twinrix Junior | Subjects received Twinrixâ„¢ Junior (360/10) in a 0, 1, 6 month schedule in the primary study. | 0 | 126 | 0 | 126 | ||
| EG001 | Group Twinrix Adult | Subjects received Twinrixâ„¢ Adult (720/20) in a 0, 6 month schedule in the primary study. | 0 | 118 | 0 | 118 |
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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 |
| D006506 | Hepatitis A |
| 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 |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| Male |
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| Year 8 (n= 104, 93) |
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| Year 9 (n= 103, 90) |
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| Year 10 (n= 100, 77) |
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