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To evaluate the response to an additional dose (challenge dose) of hepatitis B vaccine, when given to subjects who had received primary vaccination of Engerix™-B vaccine approximately 72-78 months ago.
This protocol posting deals with objectives & outcome measures of the challenge phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Engerix 2 Doses + Challenge Dose | Experimental | Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study. |
|
| Engerix 3 Doses + Challenge Dose | Experimental | Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engerix™-B | Biological | One dose (10µg Hepatitis B surface antigen (HBsAg)) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration | Immune response defined as:
| 30 days post-challenge dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL. | 30 days post-challenge dose |
| Concentration of Anti-HBs Antibodies |
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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 | Westmead | New South Wales | 2145 | Australia | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21171982 | Background | Van Damme P, Moiseeva A, Marichev I, Kervyn AD, Booy R, Kuriyakose S, Brockway A, Ng SP, Leyssen M, Jacquet JM. Five years follow-up following two or three doses of a hepatitis B vaccine in adolescents aged 11-15 years: a randomised controlled study. BMC Infect Dis. 2010 Dec 20;10:357. doi: 10.1186/1471-2334-10-357. |
| 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 |
|---|---|---|---|
| 108988 | Informed Consent Form | 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 | Engerix 2 Doses + Challenge Dose | Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study. |
| FG001 | Engerix 3 Doses + Challenge Dose | Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Engerix 2 Doses + Challenge Dose | Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study. |
| BG001 | Engerix 3 Doses + Challenge Dose |
| 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 Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration | Immune response defined as:
| Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data from the Australian center were not included following data quality issues detected at the investigator site. | Posted | Number | participants | 30 days post-challenge dose |
|
Solicited local and general symptoms: during the 4-day follow-up period (Day 0-3) after the challenge dose. Unsolicited AEs and serious AEs (SAEs): during the 31-day follow-up period (Day 0-30) after the challenge dose.
Data from the Australian center were not included following data quality issues detected at the investigator site.
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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 | Engerix 2 Doses + Challenge Dose | Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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Concentrations given as geometric mean concentration (GMC) and expressed in mIU/mL.
| 30 days post-challenge dose |
| Number of Participants Reporting Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling. | During the 4-day follow-up period (Day 0-3) after the challenge dose |
| Number of Participants Reporting Solicited General Symptoms | Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache. | During the 4-day follow-up period (Day 0-3) after the challenge dose |
| Number of Participants 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 31-day follow-up period (Day 0-30) after the challenge dose |
| Number of Participants Reporting Serious Adverse Events (SAE) | 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 follow-up period (Day 0-30) after the challenge dose |
| Brussels |
| 1200 |
| Belgium |
| GSK Investigational Site | Wilrijk | 2610 | Belgium |
For additional information about this study please refer to the GSK Clinical Study Register |
| 108988 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108988 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108988 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 108988 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Engerix 3 Doses + Challenge Dose | Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study. |
|
|
| Secondary | Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value | Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL. | Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data from the Australian center were not included following data quality issues detected at the investigator site. | Posted | Number | participants | 30 days post-challenge dose |
|
|
|
| Secondary | Concentration of Anti-HBs Antibodies | Concentrations given as geometric mean concentration (GMC) and expressed in mIU/mL. | Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data from the Australian center were not included following data quality issues detected at the investigator site. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | 30 days post-challenge dose |
|
|
|
| Secondary | Number of Participants Reporting Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling. | Analysis was performed on the Total Vaccinated Cohort. Data from the Australian center were not included following data quality issues detected at the investigator site. | Posted | Number | participants | During the 4-day follow-up period (Day 0-3) after the challenge dose |
|
|
|
| Secondary | Number of Participants Reporting Solicited General Symptoms | Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache. | Analysis was performed on the Total Vaccinated Cohort. Data from the Australian center were not included following data quality issues detected at the investigator site. | Posted | Number | participants | During the 4-day follow-up period (Day 0-3) after the challenge dose |
|
|
|
| Secondary | Number of Participants 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 Total Vaccinated Cohort. Data from the Australian center were not included following data quality issues detected at the investigator site. | Posted | Number | participants | During the 31-day follow-up period (Day 0-30) after the challenge dose |
|
|
|
| Secondary | Number of Participants Reporting Serious Adverse Events (SAE) | 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. | Analysis was performed on the Total Vaccinated Cohort. This table describes SAEs reported by all subjects except for those enrolled in the Australian center. | Posted | Number | participants | During the 31-day follow-up period (Day 0-30) after the challenge dose |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 39 |
| 55 |
| EG001 | Engerix 3 Doses + Challenge Dose | Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study. | 0 | 22 | 0 | 22 | 14 | 22 |
| Pain | General disorders | Systematic Assessment |
|
| Redness | General disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Gastrointestinal disorder | 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.
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D045424 |
| Complex Mixtures |
| ≥ 100 mIU/mL |
|
| Swelling |
|
| Gastrointestinal disorder |
|
| Headache |
|