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This study will evaluate the persistence of the immune response to HAV (Hepatitis A Virus) antigens and HBs (Hepatitis B surface) antigens in healthy adults previously vaccinated with GlaxoSmithKline (GSK) Biologicals' Twinrix Adult. The subjects will be invited for blood sampling 16, 17, 18, 19 and 20 years after vaccination to evaluate the antibody persistence. For subjects in whom low circulating antibodies are detected, the presence of immune memory against hepatitis A & B antigens will be investigated by the administration of a challenge dose of the appropriate vaccine (Havrix and/or Engerix-B) at the next planned visit.
No new subjects will be recruited during this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Twinrix Group | Experimental | Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Procedure | Blood sampling at Year 16, 17, 18, 19 and 20 and at the time of challenge dose administration and 14 days and one month after challenge dose administration (if challenge dose needed). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody Concentrations >= 10 Milliinternational Units Per Milliliter (mIU/mL) | Seropositivity for anti-HAV antibodies is defined as antibody concentrations >= 15 milliinternational units per milliliter (mIU/mL). Seropositivity for anti-HBs antibodies is defined as antibody concentrations >= 6.2 mIU/mL. | At Years 16, 17, 18, 19 and 20. |
| Anti-HAV and Anti-HBs Geometric Mean Concentrations (GMCs) | Concentrations were expressed as GMCs in mIU/mL. | At Years 16, 17, 18, 19 and 20. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Immune Response to the Challenge Vaccine Antigen | None of the subjects received a challenge dose at Years 16, 17, 18 and 20 while, one subject received the challenge dose at Year 19. | Before, 14 days and one month after the challenge dose at Year 19. |
| Anti-hepatitis B Virus (Anti-HBs) Antibody Concentration |
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Inclusion Criteria:
All subjects must satisfy the following criteria at entry into each of the long-term follow-up visits:
All subjects must satisfy the following criteria at entry into the challenge dose phase:
Exclusion Criteria:
The following criteria should be checked before entry into each of the long-term follow-up visits. If any exclusion criterion applies, the subject must not be included in the study:
The following criteria should be checked before the challenge dose is administered. 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 | Wilrijk | 2610 | Belgium |
| 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. |
| 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 |
|---|---|---|---|
| 112267 | 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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Subjects who entered the study at Years 16, 17, 18, 19 and 20 time points were subjects who completed the primary study and who returned for blood sampling at the considered time point. At Year 19 time point, one subject was given a challenge dose of Engerix.
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| ID | Title | Description |
|---|---|---|
| FG000 | Twinrix Group | Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year 16 |
| |||||||||||||
| Year 17 |
| |||||||||||||
| Year 18 |
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| Year 19 |
| |||||||||||||
| Year 20 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Twinrix Group | Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule |
| 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 16 |
| 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 Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody Concentrations >= 10 Milliinternational Units Per Milliliter (mIU/mL) | Seropositivity for anti-HAV antibodies is defined as antibody concentrations >= 15 milliinternational units per milliliter (mIU/mL). Seropositivity for anti-HBs antibodies is defined as antibody concentrations >= 6.2 mIU/mL. | The analysis was performed on the Long-Term (LT) According-to-Protocol (ATP) cohort for analysis of immunogenicity. They were included in the ATP analysis for the primary study, did not receive hepatitis A or B (hep A/B) vaccination that was not specified in the protocol and were not eliminated for abnormal increase of antibody concentrations. | Posted | Number | Subjects | At Years 16, 17, 18, 19 and 20. |
|
SAEs: During the 31-day (Days 0 to 30) follow-up period after the challenge dose and from the beginning of the long term follow-up to Year 20; Unsolicited symptoms: During the 31-day (Days 0 to 30) follow-up period after the challenge dose.
As no challenge dose was administered during Years 16, 17, 18 and 20 time points, SAEs and other adverse events were not assessed. 1 subject received the challenge dose at Year 19 for whom the SAEs and other adverse events were assessed during the 31 day period post challenge dose. SAEs were also collected for the entire safety follow-up.
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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 Group | Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | 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 partial or complete retesting/reanalysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D006506 | Hepatitis A |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| C075654 | Engerix-B |
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Engerix-B | Biological | Engerix-B will be administered to subjects who are not seroprotected against hepatitis B |
|
| Havrix | Biological | Havrix will be administered to subjects who are seronegative for anti-HAV antibodies |
|
Concentrations are given as Geometric Mean Concentrations (GMCs) expressed as mIU/mL. |
| At Year 18, 14 days and 30 days post challenge dose (Year 19). |
| Number of Subjects Reporting Unsolicited Adverse Events (AE) | An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. | During the 31-day (Day 0 to 30) period after administration of the challenge dose at Year 19. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | A serious adverse event was 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 31-day (Day 0 to 30) period after administration of the challenge dose at Year 19. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | A serious adverse event is any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, or was a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. 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. | Up to Year 20. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 112267 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112267 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112267 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112267 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112267 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112267 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Number of participants at year 16 are equal to the overall number of participants analyzed, which represents the highest number of participants from year 16 to year 20.
| Mean |
| Standard Deviation |
| Years |
|
| Age, Continuous | The baseline measure data here corresponds to Year 17 | Number of participants analyzed represents all subjects who returned at the year 17 annual time point. | Mean | Standard Deviation | Years |
|
| Age, Continuous | The baseline measure data here corresponds to Year 18 | Number of participants analyzed represents all subjects who returned at the year 18 annual time point. | Mean | Standard Deviation | Years |
|
| Age, Continuous | The baseline measure data here corresponds to Year 19 | Number of participants analyzed represents all subjects who returned at the year 19 annual time point. | Mean | Standard Deviation | Years |
|
| Age, Continuous | The baseline measure data here corresponds to Year 20 | Number of participants analyzed represents all subjects who returned at the year 20 annual time point. | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | The baseline measure data here corresponds to Year 16 | Number of participants at year 16 are equal to the overall number of participants analyzed, which represents the highest number of participants from year 16 to year 20. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Year 17 | Number of participants analyzed represents all subjects who returned at the year 17 annual time point. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Year 18 | Number of participants analyzed represents all subjects who returned at the year 18 annual time point. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Year 19 | Number of participants analyzed represents all subjects who returned at the year 19 annual time point. | Count of Participants | Participants |
|
| Sex: Female, Male | The baseline measure data here corresponds to Year 20 | Number of participants analyzed represents all subjects who returned at the year 20 annual time point. | Count of Participants | Participants |
|
Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
|
|
| Primary | Anti-HAV and Anti-HBs Geometric Mean Concentrations (GMCs) | Concentrations were expressed as GMCs in mIU/mL. | The analysis was performed on the Long-Term (LT) According-to-Protocol (ATP) cohort for analysis of immunogenicity.They were included in the ATP analysis for the primary study, did not receive hepatitis A or B vaccination that was not specified in the protocol and were not eliminated for abnormal increase of antibody concentrations. | Posted | Geometric Mean | 95% Confidence Interval | milli-international units per milliliter | At Years 16, 17, 18, 19 and 20. |
|
|
|
| Secondary | Number of Subjects With Immune Response to the Challenge Vaccine Antigen | None of the subjects received a challenge dose at Years 16, 17, 18 and 20 while, one subject received the challenge dose at Year 19. | The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study. | Posted | Number | Subjects | Before, 14 days and one month after the challenge dose at Year 19. |
|
|
|
| Secondary | Anti-hepatitis B Virus (Anti-HBs) Antibody Concentration | Concentrations are given as Geometric Mean Concentrations (GMCs) expressed as mIU/mL. | The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study. | Posted | Geometric Mean | 95% Confidence Interval | milli-international units per milliliter | At Year 18, 14 days and 30 days post challenge dose (Year 19). |
|
|
|
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AE) | An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. | The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study | Posted | Number | Subjects | During the 31-day (Day 0 to 30) period after administration of the challenge dose at Year 19. |
|
|
|
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) | A serious adverse event was 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. | The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study. | Posted | Number | Subjects | During the 31-day (Day 0 to 30) period after administration of the challenge dose at Year 19. |
|
|
|
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) | A serious adverse event is any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, or was a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. 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. | The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study. | Posted | Number | Subjects | Up to Year 20. |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 1 |
| 1 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | 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.
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
|
| anti-HBs [at Year 17] (N=19) |
|
| anti-HAV [at Year 18] (N=10) |
|
| anti-HBs [at Year 18] (N=10) |
|
| anti-HAV [at Year 19] (N=17) |
|
| anti-HBs [at Year 19] (N=18) |
|
| anti-HAV [at Year 20] (N=18) |
|
| anti-HBs [at Year 20] (N=18) |
|
| [Subject 1; 30 days post challenge dose] |
|