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The purpose of this study is to evaluate the persistence of hepatitis A antibodies, approximately 8 years and 10 years post vaccination with the complete series of Havrix (2 doses) and the partial series completion (1 dose).
The study comprises of two independent cross-sectional surveys (Year 8 and Year 10). The first cross-sectional serosurvey will evaluate the long term persistence of immunity approximately 8 years post vaccine administration and the second cross-sectional study will evaluate long term persistence, approximately 10 years post vaccine administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Havrix 1 dose_Year 8 Group | Other | Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey. |
|
| Havrix 2 doses_Year 8 Group | Other | Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey. |
|
| Havrix 1 dose_Year 10 Group | Other | Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 10 years and less than (<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey. |
|
| Havrix 2 doses_Year 10 Group | Other | Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 10 years and less than (<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample collection | Other | A blood sample (~5mL) will be collected from all subjects at each cross-sectional survey (Year 8 and Year 10). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose | Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 milli-international unit/milliliter (mIU/mL). | At approximately 8 years after the last administered vaccine dose |
| Number of Subjects With Anti-HAV Seropositivity Status at Approximately 10 Years Following Last Administered Havrix Dose | Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL. | At approximately 10 years after the last administered vaccine dose |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HAV Antibody Concentrations at Approximately 8 Years Following Last Administered Havrix Dose | Anti-HAV antibody concentrations were measured by ELISA, expressed as GMCs, in mIU/mL. The cut-off of the assay was an anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL. | At approximately 8 years after the last administered vaccine dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Chiriquí | Panama | ||||
| GSK Investigational Site |
IPD for this study will be made available via the Clinical Study Data Request site
IPD will be made available within 6 months of publishing the results of the primary endpoints of the study
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months
The design of the study included 2 epochs: Epoch 001 - Persistence at Year 8 and Epoch 002 - Persistence at Year 10.
The study was conducted at 4 centers in Panama. Out of the 1201 subjects originally enrolled in the study, 2 subjects were eliminated from the ATP cohort for persistence, due to non-eligibility. Hence, 1199 subjects were included in the ATP cohort for persistence.
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| ID | Title | Description |
|---|---|---|
| FG000 | Havrix 1 dose_Year 8 Group | Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Epoch 001: Persistence at Year 8 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 29, 2018 | Aug 21, 2019 |
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| Anti-HAV Antibody Concentrations at Approximately 10 Years Following Last Administered Havrix Dose | Anti-HAV antibody concentrations were measured by ELISA, expressed as GMCs, in mIU/mL. The cut-off of the assay was an anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL. | At approximately 10 years after the last administered vaccine dose |
| Number of Subjects With Anti-HAV Antibody Concentration ≥ 15 mIU/mL at Approximately 8 Years Following Last Administered Havrix Dose - Exploration of Non-inferiority of the 1-dose Schedule Compared to the 2-dose Schedule of Havrix | Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL. | At approximately 8 years after the last administered vaccine dose |
| Number of Subjects With Anti-HAV Antibody Concentrations ≥ 15 mIU/mL at Approximately 10 Years Following Last Administered Havrix Dose - Exploration of Non-inferiority of the 1-dose Schedule Compared to the 2-dose Schedule of Havrix | Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL. | At approximately 10 years after the last administered vaccine dose |
| Juán Diaz |
| Panama |
| GSK Investigational Site | Panama City | Panama |
| Havrix 2 doses_Year 8 Group |
Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey. |
| FG002 | Havrix 1 dose_Year 10 Group | Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 10 years and less than (<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey. |
| FG003 | Havrix 2 doses_Year 10 Group | Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 10 years and less than (<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey. |
| COMPLETED |
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| NOT COMPLETED |
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| Epoch 002: Persistence at Year 10 |
|
The demographic characteristics are presented separately for each study epoch (Epoch 001: Persistence at Year 8 and Epoch 002: Persistence at Year 10).
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| ID | Title | Description |
|---|---|---|
| BG000 | Havrix 1 dose_Year 8 Group | Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey. |
| BG001 | Havrix 2 doses_Year 8 Group | Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey. |
| BG002 | Havrix 1 dose_Year 10 Group | Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 10 years and less than (<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey. |
| BG003 | Havrix 2 doses_Year 10 Group | Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 10 years and less than (<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age continuous data for Epoch 001: Persistence at Year 8 | The age continuous data in this baseline measure are reported for Havrix 1 dose_Year 8 and Havrix 2 doses_Year 8 Groups. | Mean | Standard Deviation | Years |
| ||||||||
| Age, Continuous | Age continuous data for Epoch 002: Persistence at Year 10 | The age continuous data in this baseline measure are reported for Havrix 1 dose_Year 10 and Havrix 2 doses_Year 10 Groups. | Mean | Standard Deviation | Years |
| ||||||||
| Sex: Female, Male | Sex: Female, Male data for Epoch 001: Persistence at Year 8 | The sex: female, male data in this baseline measure are reported for Havrix 1 dose_Year 8 and Havrix 2 doses_Year 8 Groups. | Count of Participants | Participants |
| |||||||||
| Sex: Female, Male | Sex: female, male data for Epoch 002: Persistence at Year 10 | The sex: female, male data in this baseline measure are reported for Havrix 1 dose_Year 10 and Havrix 2 doses_Year 10 Groups. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race/Ethnicity data for Epoch 001: Persistence at Year 8 | The race/ethnicity data in this baseline measure are reported for Havrix 1 dose_Year 8 and Havrix 2 doses_Year 8 Groups. | Count of Participants | Participants |
| |||||||||
| Race/Ethnicity, Customized | Race/ethnicity data for Epoch 002: Persistence at Year 10 | The race/ethnicity data in this baseline measure are reported for Havrix 1 dose_Year 10 and Havrix 2 doses_Year 10 Groups. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose | Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 milli-international unit/milliliter (mIU/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Year 8, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 8 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records. | Posted | Count of Participants | Participants | At approximately 8 years after the last administered vaccine dose |
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| Primary | Number of Subjects With Anti-HAV Seropositivity Status at Approximately 10 Years Following Last Administered Havrix Dose | Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL. | The analysis was performed on the ATP cohort for persistence at Year 10, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 10 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records. | Posted | Count of Participants | Participants | At approximately 10 years after the last administered vaccine dose |
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| Secondary | Anti-HAV Antibody Concentrations at Approximately 8 Years Following Last Administered Havrix Dose | Anti-HAV antibody concentrations were measured by ELISA, expressed as GMCs, in mIU/mL. The cut-off of the assay was an anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL. | The analysis was performed on the ATP cohort for persistence at Year 8, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 8 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At approximately 8 years after the last administered vaccine dose |
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| Secondary | Anti-HAV Antibody Concentrations at Approximately 10 Years Following Last Administered Havrix Dose | Anti-HAV antibody concentrations were measured by ELISA, expressed as GMCs, in mIU/mL. The cut-off of the assay was an anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL. | The analysis was performed on the ATP cohort for persistence at Year 10, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 10 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At approximately 10 years after the last administered vaccine dose |
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| Secondary | Number of Subjects With Anti-HAV Antibody Concentration ≥ 15 mIU/mL at Approximately 8 Years Following Last Administered Havrix Dose - Exploration of Non-inferiority of the 1-dose Schedule Compared to the 2-dose Schedule of Havrix | Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL. | The analysis was performed on the ATP cohort for persistence at Year 8, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 8 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records. | Posted | Count of Participants | Participants | At approximately 8 years after the last administered vaccine dose |
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| Secondary | Number of Subjects With Anti-HAV Antibody Concentrations ≥ 15 mIU/mL at Approximately 10 Years Following Last Administered Havrix Dose - Exploration of Non-inferiority of the 1-dose Schedule Compared to the 2-dose Schedule of Havrix | Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL. | The analysis was performed on the ATP cohort for persistence at Year 10, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 10 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records. | Posted | Count of Participants | Participants | At approximately 10 years after the last administered vaccine dose |
|
SAEs: Epoch 001: from Visit at Year 8 (the time of sample collection) up to study conclusion (i.e. during an approximate period of 15 months); Epoch 002: from Visit at Year 10 (the time of sample collection) up to study conclusion (i.e. during an approximate period of 8 months).
Only SAEs related to study procedures were collected during the entire study period.
There were no other adverse events (AEs) data collected during the entire study period.
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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 | Havrix 1 dose_Year 8 Group | Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 7 years and less than (<) 10 years between the administration of the vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey. | 0 | 300 | 0 | 300 | 0 | 0 |
| EG001 | Havrix 2 doses_Year 8 Group | Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 7 years and less than (<) 10 years between the administration of the last vaccine dose and the Persistence Visit at Year 8 and who participated in the Year 8 cross-sectional survey. | 0 | 300 | 0 | 300 | 0 | 0 |
| EG002 | Havrix 1 dose_Year 10 Group | Subjects who received one dose of Havrix vaccine and with more than or equal to (≥) 10 years and less than (<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey. | 0 | 299 | 0 | 299 | 0 | 0 |
| EG003 | Havrix 2 doses_Year 10 Group | Subjects who received two doses of Havrix vaccine and with more than or equal to (≥) 10 years and less than (<) 13 years between the administration of the vaccine dose and the Persistence Visit at Year 10 and who participated in the Year 10 cross-sectional survey. | 0 | 300 | 0 | 300 | 0 | 0 |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 24, 2017 | Aug 21, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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