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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 Twinrix Adult in the primary study, HAB-032 (208127/022). The subjects will be invited for blood sampling 16, 17, 18, 19 and 20 years after the primary 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 | Subjects who received 2 doses of Twinrix (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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point. |
|
| 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 |
|---|---|---|
| Anti-HBs Concentrations After the Challenge Dose of Engerix-B | Concentration was given in mIU/mL. Only 1 subject was eligible for the challenge dose of Engerix-B at the Year 16 time point. Therefore the values for this subject are given without a measure of dispersion. | Before, 14 days and one month (30 days) after the challenge dose of Engerix-B. |
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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 | Ghent | 9000 | 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 |
|---|---|---|---|
| 112266 | 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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1 subject who was not able to come at Year (Y) 16 entered the study at Y17. At Y16, 1 subject was administered a challenge dose of Engerix-B vaccine and at Y18 and Y20, 2 subjects were administered a challenge dose of Havrix vaccine. None of the subjects received a challenge dose at Y17 and Y19.
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| ID | Title | Description |
|---|---|---|
| FG000 | Twinrix Group | Subjects who received 3 doses of Twinrix (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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year 16 |
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| Year 17 |
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| Year 18 |
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| Year 19 |
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| Year 20 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Twinrix Group | Subjects who received 3 doses of Twinrix (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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point. |
| 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 according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at a particular blood sampling time point, who were included in the ATP analysis for the primary study and who did not receive hepatitis A or B vaccination that was not specified in the protocol. | 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 17 and 19 time points, SAEs and other adverse events were not assessed. At Year 16, 1 subject was administered a challenge dose of Engerix-B vaccine and at Years 18 and 20, 2 subjects were administered a challenge dose of Havrix vaccine, 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 | Subjects who received 3 doses of Twinrix (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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
A decrease in specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody(10-100 mIU/mL).The tables show updated results following complete retesting/reanalysis for Y16-18.Y19 & 20 results were only analyzed by CLIA.
| 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. |
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| Havrix | Biological | Havrix will be administered to subjects who are seronegative for anti-HAV antibodies. |
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| Anti-HAV Concentrations After the Challenge Dose of Havrix | Concentration was given in mIU/mL. Only 2 subjects were eligible for the challenge dose of Havrix, one at Year 18 and another at Year 20 time point. Therefore the values for these subject are given without a measure of dispersion. | Before, 14 days and one month (30 days) after the challenge dose of Havrix. |
| Number of Subjects With Anamnestic Response to the Challenge Dose of Engerix-B | At Year 16 only 1 subject was eligible for the challenge dose of Engerix-B. Anti-HBs anamnestic response to the challenge dose was defined as:
| 30 days after the challenge dose of Engerix-B. |
| Number of Subjects With Anamnestic Response to the Challenge Dose of Havrix | Anti-HAV anamnestic response to the challenge dose was defined as:
| 30 days after the challenge dose of Havrix. |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | At Year 16, 1 subject was administered a challenge dose of Engerix-B and at Y18 and Y20, 2 subjects were administered a challenge dose of Havrix. 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. | 31 days (Days 0-30) after the challenge dose of Engerix-B and Havrix. |
| Number of Subjects With Serious Adverse Events (SAEs) | Only 1 subject received a challenge dose at Year 16 of Engerix-B. 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. | During the 31-day (Days 0-30) follow-up period after the Engerix-B challenge dose. |
| Number of Subjects With Serious Adverse Events (SAEs) | One subject received a challenge dose of Havrix at Year 18 and another at Year 20. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | During the 31-day (Days 0-30) follow-up period after the Havrix challenge dose. |
| Number of Subjects Reporting SAEs Related to Study Participation or a Concurrent GSK Medication | 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. | Up to Year 20. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 112266 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112266 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112266 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112266 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112266 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112266 | 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 |
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| 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 |
|
Subjects who received 3 doses of Twinrix (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 first long-term follow-up NCT00289718 and this long-term follow-up.
A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point.
|
|
| 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 according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at a particular blood sampling time point, who were included in the ATP analysis for the primary study and who did not receive hepatitis A or B vaccination that was not specified in the protocol. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Years 16, 17, 18, 19 and 20. |
|
|
|
| Secondary | Anti-HBs Concentrations After the Challenge Dose of Engerix-B | Concentration was given in mIU/mL. Only 1 subject was eligible for the challenge dose of Engerix-B at the Year 16 time point. Therefore the values for this subject are given without a measure of dispersion. | The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine because their anti-HBs antibody concentrations were < 10 mIU/mL. | Posted | Number | mIU/mL | Before, 14 days and one month (30 days) after the challenge dose of Engerix-B. |
|
|
|
| Secondary | Anti-HAV Concentrations After the Challenge Dose of Havrix | Concentration was given in mIU/mL. Only 2 subjects were eligible for the challenge dose of Havrix, one at Year 18 and another at Year 20 time point. Therefore the values for these subject are given without a measure of dispersion. | The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Havrix vaccine because their anti-HAV antibody concentrations were < 15 mIU/mL. | Posted | Number | mIU/mL | Before, 14 days and one month (30 days) after the challenge dose of Havrix. |
|
|
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| Secondary | Number of Subjects With Anamnestic Response to the Challenge Dose of Engerix-B | At Year 16 only 1 subject was eligible for the challenge dose of Engerix-B. Anti-HBs anamnestic response to the challenge dose was defined as:
| The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine because their anti-HBs antibody concentrations were < 10 mIU/mL. | Posted | Number | Subjects | 30 days after the challenge dose of Engerix-B. |
|
|
|
| Secondary | Number of Subjects With Anamnestic Response to the Challenge Dose of Havrix | Anti-HAV anamnestic response to the challenge dose was defined as:
| The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Havrix vaccine because their anti-HAV antibody concentrations were < 15 mIU/mL. | Posted | Number | subjects | 30 days after the challenge dose of Havrix. |
|
|
|
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | At Year 16, 1 subject was administered a challenge dose of Engerix-B and at Y18 and Y20, 2 subjects were administered a challenge dose of Havrix. 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. | The analysis was performed on the long-term total cohort which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine or Havrix. | Posted | Number | Subjects | 31 days (Days 0-30) after the challenge dose of Engerix-B and Havrix. |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Only 1 subject received a challenge dose at Year 16 of Engerix-B. 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. | The analysis was performed on the long-term total cohort which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine because their anti-HBs antibody concentrations were < 10 mIU/mL. | Posted | Number | Subjects | During the 31-day (Days 0-30) follow-up period after the Engerix-B challenge dose. |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | One subject received a challenge dose of Havrix at Year 18 and another at Year 20. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the long-term total cohort which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Havrix vaccine because their anti-HAV antibody concentrations were < 15 mIU/mL. | Posted | Number | subjects | During the 31-day (Days 0-30) follow-up period after the Havrix challenge dose. |
|
|
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| Secondary | Number of Subjects Reporting SAEs Related to Study Participation or a Concurrent GSK Medication | 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. | The LT Total cohort included all subjects who returned at each annual time point and who belonged to the Total cohort in the primary study. | Posted | Number | Subjects | Up to Year 20. |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 1 |
| 3 |
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=27) |
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| anti-HAV [at Year 18] (N=25) |
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| anti-HBs [at Year 18] (N=25) |
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| anti-HAV [at Year 19] (N=25) |
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| anti-HBs [at Year 19] (N=25) |
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| anti-HAV [at Year 20] (N=25) |
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| anti-HBs [at Year 20] (N=25) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| before challenge dose at Year 20 |
|
| 14 days after challenge dose at Year 20 |
|
| 1 month (Day 30) after challenge dose at Year 20 |
|