Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 100557 (Y12) | Other Identifier | GSK | |
| 100558 (Y13) | Other Identifier | GSK | |
| 100559 (Y14) | Other Identifier | GSK | |
| 100560 (Y15) | Other Identifier | GSK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 years after subjects received their first dose of a 3 dose vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
This protocol posting deals with objectives & outcome measures of the extension phase at year 11 to 15.
This is a long-term follow-up study at Years 11, 12, 13, 14 and 15 after primary vaccination with GSK Biologicals' hepatitis A/hepatitis B vaccine (three-dose schedule, 3 different lots). To evaluate the long-term antibody persistence, volunteers will be bled at Years 11, 12, 13, 14 and 15 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.
No additional subjects will be recruited during the course of this long-term study.
If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 11, 12, 13, 14 or 15), he/ she will be offered an additional vaccine dose.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Twinrix Group | Experimental | Subjects who received 2 doses of Twinrixâ„¢ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Twinrixâ„¢ adult | Biological | Intramuscular administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration | Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL). | At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Solicited local symptoms assessed include pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. >100mm. | During the 4-day (Day 0-3) follow-up period after additional HBV vaccination |
| Number of Subjects Seropositive for Anti-HAV Antibodies | A seropositive subject was defined as a vaccinated subject who had a anti-HAV antibody titres ≥ 33 mIU/ml. | At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination |
| Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration | Concentrations given as GMC expressed as mIU/mL. NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA). From Year 11 to Year 14, anti-HBs antibody concentrations were tested with ELISA with cut-off of 3.3 mIU/mL while, Year 14* onwards, anti-HBs antibody concentrations were tested with the CLIA with cut-off of 6.2 mIU/mL. | At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination |
| Number of Subjects Seropositive for Anti-HB Antibodies | A seropositive subject was defined as a vaccinated subject who had anti-HB antibody titres ≥ 1 mIU/mL. NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA) |
Not provided
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11505437 | Background | Van Damme P, Leroux-Roels G, Law B, Diaz-Mitoma F, Desombere I, Collard F, Tornieporth N, Van Herck K. Long-term persistence of antibodies induced by vaccination and safety follow-up, with the first combined vaccine against hepatitis A and B in children and adults. J Med Virol. 2001 Sep;65(1):6-13. | |
| 22052690 | Background |
| 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 |
|---|---|---|---|
| 100556 (Y11) | 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Twinrix Group | Subjects who received 2 doses of Twinrixâ„¢ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Twinrix Group | Subjects who received 2 doses of Twinrixâ„¢ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 A Virus (Anti-HAV) Antibody Concentration | Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL). | Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination |
|
Serious Adverse Events (SAEs):Up to Year 15 and after additional HBV vaccination;Solicited local and general symptoms:During the 4-day follow-up period post additional dose;Unsolicited AEs:During the 30-day follow-up period post additional dose.
Safety results were reported for subjects who received an additional vaccine dose. Only one subject received an additional dose
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Twinrix Group | Subjects who received 2 doses of Twinrixâ„¢ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hallux valgus | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | 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 |
Not provided
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D006506 | Hepatitis A |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination |
| Number of Subjects Seroprotected for Anti-HBs Antibodies. | A seroprotected subject was defined as a subjects with the anti-HBs titres ≥ 10 mIU/mL. NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA) | At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination |
| Number of Subjects Reporting Serious Adverse Events (SAE) | A SAE was defined as any untoward medical occurrence that: resulted in death, was 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. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. | During the follow-up period after additional vaccination (minimum 30 days) |
| Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration | Concentrations given as GMC expressed as mIU/mL. If a subject became seronegative (< 10 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose. | Before the additional dose and 1 month after the additional dose |
| Number of Subjects Reporting Any Solicited General Symptoms. | Solicited general symptoms assessed included fatigue, headache, malaise, nausea, vomiting and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. | During the 4-day (Day 0-3) follow-up period after additional HBV vaccination |
| Number of Subjects Reporting Unsolicited Adverse Events (AE) | An AE is 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. | During the 30-day follow-up period after additional vaccination |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | A SAE was defined as any untoward medical occurrence that: resulted in death, was 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. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. | At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination |
| Van Damme P, Leroux-Roels G, Crasta P, Messier M, Jacquet JM, Van Herck K. Antibody persistence and immune memory in adults, 15 years after a three-dose schedule of a combined hepatitis A and B vaccine. J Med Virol. 2012 Jan;84(1):11-7. doi: 10.1002/jmv.22264. Epub 2011 Nov 3. |
| 17448944 | Background | Van Herck K, Leroux-Roels G, Van Damme P, Srinivasa K, Hoet B. Ten-year antibody persistence induced by hepatitis A and B vaccine (Twinrix) in adults. Travel Med Infect Dis. 2007 May;5(3):171-5. doi: 10.1016/j.tmaid.2006.07.003. Epub 2006 Sep 20. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 100556 (Y11) | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100556 (Y11) | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 100556 (Y11) | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 100556 are summarised with studies 100557, 100558, 100559, and 100560 on the GSK Clinical Study Register. |
| 100556 (Y11) | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Solicited local symptoms assessed include pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. >100mm. | Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose. Only 1 subject received an additional dose. | Posted | Number | subjects | During the 4-day (Day 0-3) follow-up period after additional HBV vaccination |
|
|
|
| Primary | Number of Subjects Seropositive for Anti-HAV Antibodies | A seropositive subject was defined as a vaccinated subject who had a anti-HAV antibody titres ≥ 33 mIU/ml. | Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint | Posted | Number | Subjects | At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination |
|
|
|
| Primary | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration | Concentrations given as GMC expressed as mIU/mL. NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA). From Year 11 to Year 14, anti-HBs antibody concentrations were tested with ELISA with cut-off of 3.3 mIU/mL while, Year 14* onwards, anti-HBs antibody concentrations were tested with the CLIA with cut-off of 6.2 mIU/mL. | Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination |
|
|
|
| Primary | Number of Subjects Seropositive for Anti-HB Antibodies | A seropositive subject was defined as a vaccinated subject who had anti-HB antibody titres ≥ 1 mIU/mL. NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA) | Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint | Posted | Number | Subjects | At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination |
|
|
|
| Primary | Number of Subjects Seroprotected for Anti-HBs Antibodies. | A seroprotected subject was defined as a subjects with the anti-HBs titres ≥ 10 mIU/mL. NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA) | Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint | Posted | Number | Subjects | At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination |
|
|
|
| Primary | Number of Subjects Reporting Serious Adverse Events (SAE) | A SAE was defined as any untoward medical occurrence that: resulted in death, was 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. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. | Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose. Only 1 subject received an additional dose. | Posted | Number | subjects | During the follow-up period after additional vaccination (minimum 30 days) |
|
|
|
| Primary | Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration | Concentrations given as GMC expressed as mIU/mL. If a subject became seronegative (< 10 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose. | Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose. Only 1 subject received an additional dose. | Posted | Number | mIU/mL | Before the additional dose and 1 month after the additional dose |
|
|
|
| Primary | Number of Subjects Reporting Any Solicited General Symptoms. | Solicited general symptoms assessed included fatigue, headache, malaise, nausea, vomiting and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. | Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose. Only 1 subject received an additional dose. | Posted | Number | Subjects | During the 4-day (Day 0-3) follow-up period after additional HBV vaccination |
|
|
|
| Primary | Number of Subjects Reporting Unsolicited Adverse Events (AE) | An AE is 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. | Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose. Only 1 subject received an additional dose. | Posted | Number | subjects | During the 30-day follow-up period after additional vaccination |
|
|
|
| Primary | Number of Subjects Reporting Serious Adverse Events (SAEs) | A SAE was defined as any untoward medical occurrence that: resulted in death, was 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. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. | Analysis was performed on the LT Total Cohort that included all subjects who returned at a specified follow-up study and who belonged to the Total Cohort of the primary vaccination course. | Posted | Number | Subjects | At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination |
|
|
|
| 0 |
| 1 |
| 1 |
| 1 |
| 1 |
| 1 |
| Nasopharyngitis | Infections and infestations | 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 |
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| Year 14 (N=30) |
|
| Year 15 (N=29) |
|
| Title | Measurements |
|---|---|
|
| Year 14 (N=30) |
|
| Year 14* (N=28) |
|
| Year 15 (N=29) |
|
| Title | Measurements |
|---|---|
|
| YEAR 14 (N=30) |
|
| Year 14* (N=28) |
|
| YEAR 15 (N=29) |
|
| Title | Measurements |
|---|---|
|
| YEAR 14 (N=30) |
|
| Year 14* (N=28) |
|
| YEAR 15 (N=29) |
|
| before additional dose at Year 13 |
|
| 1 month after additional dose at Year 13 |
|
| Title | Measurements |
|---|---|
|
| Any Nausea |
|
| Any Vomiting |
|
| Any Fever |
|