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Only subjects who participated in the primary study will be invited to participate in the extension phase and the challenge dose phase of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Twinrix Group | Experimental | Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix). |
|
| Engerix + Havrix Group | Active Comparator | Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix). |
|
| HB VAX PRO + Vaqta Group | Active Comparator | Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Twinrix | Biological | Intramuscular injection, single dose in left deltoid. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis A (Anti-HAV) Antibodies | Anamnestic response was defined as:
| One month after the challenge dose. |
| Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies | Anamnestic response was defined as :
| One month after the challenge dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations | Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL. | Prior to administration of challenge dose |
| Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations |
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Inclusion Criteria:
Exclusion Criteria:
The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
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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 | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21366801 | Derived | Chlibek R, von Sonnenburg F, Van Damme P, Smetana J, Tichy P, Gunapalaiah B, Leyssen M, Jacquet JM. Antibody persistence and immune memory 4 years post-vaccination with combined hepatitis A and B vaccine in adults aged over 40 years. J Travel Med. 2011 Mar-Apr;18(2):145-8. doi: 10.1111/j.1708-8305.2010.00499.x. Epub 2011 Feb 7. |
| 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 |
|---|---|---|---|
| 111572 | Dataset Specification | 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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| ID | Title | Description |
|---|---|---|
| FG000 | Twinrix Group | Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix). |
| FG001 | Engerix + Havrix Group | Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix). |
| FG002 | HB VAX PRO + Vaqta Group | Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Twinrix Group | Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix). |
| BG001 | Engerix + Havrix Group | Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix). |
| 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 | Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis A (Anti-HAV) Antibodies | Anamnestic response was defined as:
| Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. | Posted | Count of Participants | Participants | One month after the challenge dose. |
|
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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 received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arterial occlusive disease | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| 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 |
|---|---|
| C433226 | twinrix |
| C075654 | Engerix-B |
| D022362 | Hepatitis A Vaccines |
| D017325 | Hepatitis B Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Engerix-B |
| Biological |
Intramuscular injection, single dose in left deltoid. |
|
| Havrix | Biological | Intramuscular injection, single dose in right deltoid. |
|
| HBVAXPRO | Biological | Intramuscular injection, single dose in the left deltoid. |
|
| Vaqta | Biological | Intramuscular injection, single dose in right deltoid. |
|
Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL. |
| Two weeks and one month after the challenge dose |
| Number of Subjects Reporting Solicited Symptoms | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache and temperature (above 37 degree Celsius). | During the 4-day follow-up period after the challenge dose. |
| Number of Subjects Reporting Unsolicited Symptoms | Unsolicited symptoms = any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. | During the 31-day follow-up period after the challenge dose. |
| Number of Subjects With Serious Adverse Events (SAEs) Since the Last Study Visit of the HAB-160 (NCT00603252) Long-term Follow-up Study Considered by the Investigator to Have a Causal Relationship to Primary Vaccination | A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or is a sign of suspected or confirmed hepatitis A or hepatitis B. | Since the last study visit of the primary study long-term follow-up study up to challenge dose administration (1 year) |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or is a sign of suspected or confirmed hepatitis A or hepatitis B. | During one month following the administration of the challenge dose |
| Hradec Králové |
| 500 01 |
| Czechia |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111572 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111572 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111572 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111572 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111572 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Alcoholic dependance |
|
| BG002 | HB VAX PRO + Vaqta Group | Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Engerix + Havrix Group | Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix). |
| OG002 | HB VAX PRO + Vaqta Group | Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta). |
|
|
| Primary | Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies | Anamnestic response was defined as :
| Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. | Posted | Count of Participants | Participants | One month after the challenge dose. |
|
|
|
| Secondary | Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations | Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL. | Analysis was performed on the Long-Term According-to-Protocol (LT ATP) cohort for analysis of immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Prior to administration of challenge dose |
|
|
|
| Secondary | Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations | Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL. | Analysis was performed on the Log-Term According-to-Protocol (LT ATP) cohort for analysis of immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Two weeks and one month after the challenge dose |
|
|
|
| Secondary | Number of Subjects Reporting Solicited Symptoms | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache and temperature (above 37 degree Celsius). | Posted | Count of Participants | Participants | During the 4-day follow-up period after the challenge dose. |
|
|
|
| Secondary | Number of Subjects Reporting Unsolicited Symptoms | Unsolicited symptoms = any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. | Posted | Count of Participants | Participants | During the 31-day follow-up period after the challenge dose. |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) Since the Last Study Visit of the HAB-160 (NCT00603252) Long-term Follow-up Study Considered by the Investigator to Have a Causal Relationship to Primary Vaccination | A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or is a sign of suspected or confirmed hepatitis A or hepatitis B. | Posted | Count of Participants | Participants | Since the last study visit of the primary study long-term follow-up study up to challenge dose administration (1 year) |
|
|
|
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) | A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or is a sign of suspected or confirmed hepatitis A or hepatitis B. | Posted | Count of Participants | Participants | During one month following the administration of the challenge dose |
|
|
|
| 1 |
| 172 |
| 76 |
| 172 |
| EG001 | Engerix + Havrix Group | Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix). | 2 | 170 | 57 | 170 |
| EG002 | HB VAX PRO + Vaqta Group | Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta). | 0 | 164 | 75 | 164 |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nephritis interstitial | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Redness | General disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | General disorders | 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 |
| D045424 |
| Complex Mixtures |
|
| Anti-HAV (at Day 30) |
|
| Anti-HBs (at Day 14) |
|
| Anti-HBs (at Day 30) |
|
| Title | Measurements |
|---|---|
|
| Swelling |
|
| Fatigue |
|
| Gastrointestinal symptoms |
|
| Headache |
|
| Temperature |
|