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| ID | Type | Description | Link |
|---|---|---|---|
| 110700 | Other Identifier | GSK | |
| 110701 | Other Identifier | GSK | |
| 110702 | Other Identifier | GSK | |
| 110703 | Other Identifier | GSK | |
| 110704 | Other Identifier | GSK |
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This study will evaluate the immune response against Hepatitis-A (HAV) and Hepatitis B surface (HBs) antigen in healthy subjects aged 12 to 15 years (at the time of primary vaccination), who received vaccination course with GSK Biologicals' Twinrix Adult and Twinrix Junior vaccine, approximately 10 years ago in the primary study. The subjects will be invited for blood sampling at 11, 12, 13, 14 and 15 years after primary vaccination to evaluate the persistence of immune response. For subjects detected with decreased immunity, the presence of immune memory against hepatitis A & B antigens will be investigated by the administration of a challenge dose of the appropriate vaccine 6 to 12 months after the Year 15 follow-up time-point.
No new subjects will be recruited during this booster phase of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Twinrix Adult Group | Experimental | Subjects received 2 doses of Twinrixâ„¢ Adult intramuscularly according to a 0, 6 month schedule in the primary study |
|
| Twinrix Junior Group | Experimental | Subjects received 3 doses of Twinrixâ„¢ Junior (= half dose Twinrixâ„¢ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Procedure | Blood sampling at Years 11, 12, 13, 14, 15 and at the time of challenge dose administration and one month after challenge dose administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HAV Antibody Concentrations | Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HAV seropositive subjects. Seropositive subjects are subjects with anti-HAV antibody concentrations >= 15 mIU/mL. | At Year 11, 12, 13, 14 and 15 after the first vaccine dose of two-dose or three-dose primary vaccination in study HAB-084 |
| Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-Off Values | Anti-HBs antibody cut-off values assessed were >= 6.2 mIU/mL and >= 10 mIU/mL. Note: 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 for years 11 to 13. Results of year 14 and year 15 were only analysed by ChemiLuminescence ImmunoAssay (CLIA). | At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084 |
| Anti-HBs Antibody Concentrations | Antibodys concentrations are expressed as Geometric Mean concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HBs seropositive subjects. Seropositive subjects are subjects with anti-HBs antibody concentrations >= 6.2 mIU/mL. Note: 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 for years 11 to 13. Results of year 14 and year 15 were only analysed by CLIA. | At Year 11, 12, 13, 14 and 15 after the first vaccine dose of a two-dose or a three-dose primary vaccination in study HAB-084. |
| Anti-HBs Anamnestic Response. | Anamnestic response was defined as: Anti-HBs antibody concentrations ≥ 10 mIU/mL at one month post-challenge dose in subjects seronegative at the pre-challenge time-points. At least a 4-fold increase in anti-HBs antibody concentrations, at one month post-challenge dose in subjects seropositive at the pre-challenge time-points. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection. | 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. |
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Inclusion Criteria:
All subjects must satisfy the following criteria at entry into the challenge dose phase:
Exclusion Criteria:
The following criteria should be checked at each follow-up visit. If any apply at study entry, the subject must not be included at that long-term follow-up visit.
The following criteria should be checked before the challenge dose phase. If any apply, the subject must not be included in the challenge dose phase:
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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 |
|---|---|---|---|
| 32710245 | Derived | Agrawal A, Kolhapure S, Andani A, Ota MOC, Badur S, Karkada N, Mitra M. Long-Term Persistence of Antibody Response with Two Doses of Inactivated Hepatitis A Vaccine in Children. Infect Dis Ther. 2020 Dec;9(4):785-796. doi: 10.1007/s40121-020-00311-8. Epub 2020 Jul 24. | |
| 27105563 | Derived | Beran J, Van Der Meeren O, Leyssen M, D'silva P. Immunity to hepatitis A and B persists for at least 15 years after immunisation of adolescents with a combined hepatitis A and B vaccine. Vaccine. 2016 May 23;34(24):2686-91. doi: 10.1016/j.vaccine.2016.04.033. Epub 2016 Apr 20. |
| 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 |
|---|---|---|---|
| 110699 | 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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In this study, a total of 210 subjects were enrolled who participated at Year 11 (Y11) and Y12. There were a total of 8 additional subjects at Y13 and Y14 who came back from the primary study but did not participate in Y11 and Y12 as allowed by the protocol. One subject from the 210 subjects who participated in Y11 and Y12 did not return at Y15.
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| ID | Title | Description |
|---|---|---|
| FG000 | Twinrix Adult Group | Subjects received 2 doses of Twinrixâ„¢ Adult intramuscularly according to a 0, 6 month schedule in the primary study |
| FG001 | Twinrix Junior Group | Subjects received 3 doses of Twinrixâ„¢ Junior (= half dose Twinrixâ„¢ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year 11 |
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| Year 12 |
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| Year 13 |
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| Year 14 |
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| Year 15 |
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| Challenge Dose Epoch |
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| ID | Title | Description |
|---|---|---|
| BG000 | Twinrix Adult Group | Subjects received 2 doses of Twinrixâ„¢ Adult intramuscularly according to a 0, 6 month schedule in the primary study |
| BG001 | Twinrix Junior Group | Subjects received 3 doses of Twinrixâ„¢ Junior (= half dose Twinrixâ„¢ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The baseline measure data here corresponds to Year 11. |
| 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-HAV Antibody Concentrations | Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HAV seropositive subjects. Seropositive subjects are subjects with anti-HAV antibody concentrations >= 15 mIU/mL. | Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on anti-HAV seropositive subjects with available data at the specified time-points. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Year 11, 12, 13, 14 and 15 after the first vaccine dose of two-dose or three-dose primary vaccination in study HAB-084 |
|
SAEs: one month post challenge dose and up to Year 15 of the long-term follow-up, solicted symptoms: during the 4-day (Days 0-3) post challenge dose and unsolicited AEs: within the 31-day (Days 0-30) post challenge dose.
No Serious Adverse Events (SAEs) related to primary vaccination or to lack of vaccine efficacy were reported during this long-term follow-up study up to Year 15. Other (non-serious) adverse events were not assessed for the long-term follow-up phase (up to Year 15) as per protocol.
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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 | Twinrix Adult Group | Subjects received 2 doses of Twinrixâ„¢ Adult intramuscularly according to a 0, 6 month schedule in the primary study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment | One month after the administration of the challenge dose (Month 0 to Month 1) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D006506 | Hepatitis A |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Additional challenge dose | Biological | If a subject became seronegative for anti-HAV antibodies (< 15 mIU/mL) or if anti-HBs antibody concentrations decreased below 10 mIU/mL during the long-term follow-up, immune memory against the antigen was evaluated by administering a challenge dose of the appropriate antigen (vaccine) 6 to 12 months after the Year 15 follow-up time-point. |
|
| One month after the challenge dose. |
| Number of Subjects With Anti-Hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-Off Value. | Anti-HAV antibody cut-off value assessed was >= 15 milli-International Units per milliliter (mIU/mL). | At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084. |
| Since the last long-term follow-up visit up to Year 11. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection. | 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. | Since the last long-term follow-up visit up to Year 12. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection. | 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. | Since the last long-term follow-up visit up to Year 13. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection. | 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. | Since the last long-term follow-up visit up to Year 14. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection. | 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. | Since the last long-term follow-up visit up to Year 15. |
| Number of Subjects With Anti-hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-off Value. | Anti-HAV antibody cut-off value assessed was >= 15 milli-International Units per milliliter (mIU/mL). Note: Since none of the subjects were seronegative for anti-HAV antibody concentration at the pre-challenge time point, subjects received only the HBV vaccine as the challenge dose. | Before (PRE) the challenge dose |
| Anti-HAV Antibody Concentrations | Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HAV seropositive subjects. Seropositive subjects are subjects with anti-HAV antibody concentrations >= 15 mIU/mL. | Before (PRE) the challenge dose |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events. | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. | During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose |
| Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-off Values | Anti-HBs antibody cut-off values assessed were >= 6.2 mIU/mL and >= 10 mIU/mL | Before (PRE) and one month after (POST) the challenge dose |
| Anti-HBs Antibody Concentrations | Antibody concentrations are expressed as Geometric Mean concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HBs seropositive subjects. Seropositive subjects are subjects with anti-HBs antibody concentrations >= 6.2 mIU/mL. | Before (PRE) and one month after (POST) the challenge dose |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (axillary temperature). Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature > 39.5°C. Related = general symptoms which were assessed by the investigator as causally related to vaccination. | During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose. |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms. | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 = AE that prevented normal activity. Related = AE assessed by the investigator as causally related to the study vaccination. | During the 31-day (Day 0 to 30) follow-up period after the challenge dose. |
| Number of Subjects With Serious Adverse Events (SAEs). | Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. | One month after the administration of the challenge dose (Month 0 to Month 1) |
| Hradec Králové |
| 500 03 |
| Czechia |
For additional information about this study please refer to the GSK Clinical Study Register |
| 110699 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110699 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110699 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110699 | Informed Consent Form | 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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| BG002 | Total | Total of all reporting groups |
The analysis Population includes all subjects that returned for the Year 11 follow up time point.
| Mean |
| Standard Deviation |
| years |
|
| Age, Continuous | The baseline measure data here corresponds to Year 12 | The analysis Population includes all subjects that returned for the Year 12 follow up time point. | Mean | Standard Deviation | Years |
|
| Age, Continuous | The baseline measure data here corresponds to Year 13 | The analysis Population includes all subjects that returned for the Year 13 follow up time point. | Mean | Standard Deviation | Years |
|
| Age, Continuous | The baseline measure data here corresponds to Year 14 | The analysis Population includes all subjects that returned for the Year 14 follow up time point. | Mean | Standard Deviation | Years |
|
| Age, Continuous | The baseline measure data here corresponds to Year 15 | The analysis Population includes all subjects that returned for the Year 15 follow up time point. | Mean | Standard Deviation | Years |
|
| Age, Continuous | The baseline measure data here corresponds to the challenge dose epoch | The analysis Population includes all subjects that were administrated a challenge dose. | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | The baseline measure data here corresponds to Year 11. | The analysis Population includes all subjects that returned for the Year 11 follow up time point. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Year 12 | The analysis Population includes all subjects that returned for the Year 12 follow up time point. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Year 13 | The analysis Population includes all subjects that returned for the Year 13 follow up time point. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Year 14 | The analysis Population includes all subjects that returned for the Year 14 follow up time point. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Year 15 | The analysis Population includes all subjects that returned for the Year 15 follow up time point. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to the challenge dose epoch | The analysis Population includes all subjects that were administrated a challenge dose. | Count of Participants | Participants |
|
| OG001 |
| Twinrix Junior Group |
Subjects received 3 doses of Twinrixâ„¢ Junior (= half dose Twinrixâ„¢ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study |
|
|
| Primary | Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-Off Values | Anti-HBs antibody cut-off values assessed were >= 6.2 mIU/mL and >= 10 mIU/mL. Note: 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 for years 11 to 13. Results of year 14 and year 15 were only analysed by ChemiLuminescence ImmunoAssay (CLIA). | 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 Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084 |
|
|
|
| Primary | Anti-HBs Antibody Concentrations | Antibodys concentrations are expressed as Geometric Mean concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HBs seropositive subjects. Seropositive subjects are subjects with anti-HBs antibody concentrations >= 6.2 mIU/mL. Note: 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 for years 11 to 13. Results of year 14 and year 15 were only analysed by CLIA. | Analysis was performes on subjects from the Long Term According-to-Protocol (LT ATP) cohort forimmunogenicity on anti-HBs seropositive subjects with available data at the specified time-points. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Year 11, 12, 13, 14 and 15 after the first vaccine dose of a two-dose or a three-dose primary vaccination in study HAB-084. |
|
|
|
| Primary | Anti-HBs Anamnestic Response. | Anamnestic response was defined as: Anti-HBs antibody concentrations ≥ 10 mIU/mL at one month post-challenge dose in subjects seronegative at the pre-challenge time-points. At least a 4-fold increase in anti-HBs antibody concentrations, at one month post-challenge dose in subjects seropositive at the pre-challenge time-points. | Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available. | Posted | Number | Subjects | One month after the challenge dose. |
|
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|
| Primary | Number of Subjects With Anti-Hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-Off Value. | Anti-HAV antibody cut-off value assessed was >= 15 milli-International Units per milliliter (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 Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084. |
|
|
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection. | 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. | Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study. | Posted | Number | subjects | Since the last long-term follow-up visit up to Year 11. |
|
|
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection. | 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. | Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study. | Posted | Number | subjects | Since the last long-term follow-up visit up to Year 12. |
|
|
|
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection. | 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. | Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study. | Posted | Number | subjects | Since the last long-term follow-up visit up to Year 13. |
|
|
|
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection. | 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. | Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study. | Posted | Number | Subjects | Since the last long-term follow-up visit up to Year 14. |
|
|
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection. | 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. | Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study. | Posted | Number | Subjects | Since the last long-term follow-up visit up to Year 15. |
|
|
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| Secondary | Number of Subjects With Anti-hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-off Value. | Anti-HAV antibody cut-off value assessed was >= 15 milli-International Units per milliliter (mIU/mL). Note: Since none of the subjects were seronegative for anti-HAV antibody concentration at the pre-challenge time point, subjects received only the HBV vaccine as the challenge dose. | Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available. | Posted | Number | Subjects | Before (PRE) the challenge dose |
|
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| Secondary | Anti-HAV Antibody Concentrations | Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HAV seropositive subjects. Seropositive subjects are subjects with anti-HAV antibody concentrations >= 15 mIU/mL. | Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Before (PRE) the challenge dose |
|
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| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events. | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. | Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available. | Posted | Number | Subjects | During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose |
|
|
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| Secondary | Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-off Values | Anti-HBs antibody cut-off values assessed were >= 6.2 mIU/mL and >= 10 mIU/mL | Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available. | Posted | Number | Subjects | Before (PRE) and one month after (POST) the challenge dose |
|
|
|
| Secondary | Anti-HBs Antibody Concentrations | Antibody concentrations are expressed as Geometric Mean concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HBs seropositive subjects. Seropositive subjects are subjects with anti-HBs antibody concentrations >= 6.2 mIU/mL. | Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Before (PRE) and one month after (POST) the challenge dose |
|
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (axillary temperature). Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature > 39.5°C. Related = general symptoms which were assessed by the investigator as causally related to vaccination. | Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available. | Posted | Number | Subjects | During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose. |
|
|
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms. | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 = AE that prevented normal activity. Related = AE assessed by the investigator as causally related to the study vaccination. | Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available. | Posted | Number | Subjects | During the 31-day (Day 0 to 30) follow-up period after the challenge dose. |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs). | Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. | Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available. | Posted | Number | Subjects | One month after the administration of the challenge dose (Month 0 to Month 1) |
|
|
|
| 1 |
| 102 |
| 8 |
| 8 |
| EG001 | Twinrix Junior Group | Subjects received 3 doses of Twinrixâ„¢ Junior (= half dose Twinrixâ„¢ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study | 0 | 113 | 7 | 11 |
|
| Redness | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal symptoms | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
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 |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| Year 13 [6.2 mIU/mL] (N = 77;92) |
|
| Year 14 [6.2 mIU/mL] (N= 75;91) |
|
| Year 15 [6.2 mIU/mL] (N= 74;88) |
|
| Year 11 [10 mIU/mL] (N = 78;91) |
|
| Year 12 [10 mIU/mL] (N = 75;90) |
|
| Year 13 [10 mIU/mL] (N = 77;92) |
|
| Year 14 [10 mIU/mL] (N= 75;91) |
|
| Year 15 [10 mIU/mL] (N= 74;88) |
|
| Year 13 (N = 77;92) |
|
| Year 14 (N= 75;91) |
|
| Year 15 (N= 74;88) |
|
| Year 13 (N= 77; 92) |
|
| Year 14 (N= 75; 91) |
|
| Year 15 (N= 74; 88) |
|
| Any Redness |
|
| Grade 3 Redness |
|
| Any Swelling |
|
| Grade 3 Swelling |
|
| PRE [10 mIU/mL] (N = 8;11) |
|
| POST [10 mIU/mL] (N = 8;11) |
|
| Related Fatigue |
|
| Any Gastrointestinal symptoms |
|
| Grade 3 Gastrointestinal symptoms |
|
| Related Gastrointestinal symptoms |
|
| Any Headache |
|
| Grade 3 Headache |
|
| Related Headache |
|
| Any Temperature |
|
| Grade 3 Temperature |
|
| Related Temperature |
|
| Related AE(s) |
|