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In this study, subjects who received primary neonatal vaccination with hepatitis B vaccine at 0, 1, 2, 12 months, 20 years ago in the 103860/272 primary study will be evaluated for immunological memory to hepatitis B vaccine via assessment of the response to a vaccine challenge dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Neonates from mother HBsAg (+) and HBeAg (+) had received HBV vaccine at Month 0, 1, 2, 12, 60 (5 doses) |
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| Group 2 | Experimental | Neonates from mother HBsAg (+) and HBeAg (+) had received HBV vaccine at Month 0, 1, 2, 12 (4 doses) |
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| Group 4 | Experimental | Neonates from mother HBsAg (+) and HBeAg (-) had received HBV vaccine at Month 0, 1, 2, 12 (4 doses) |
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| Group 6 | Experimental | Neonates from mother HBsAg (-) and HBeAg (-) had received HBV vaccine at Month 0, 1, 2, 12 (4 doses) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engerix™-B | Biological | A challenge dose of hepatitis B vaccine will be administered to all subjects as a deep intramuscular injection in the deltoid region of the non-dominant arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With an Immune Response to a Challenge Dose of Hepatitis B Vaccine | Immune response to a challenge dose of hepatitis B vaccine is defined as
| One month after the hepatitis B vaccine challenge dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anti-HBs Antibody Concentrations Above Pre-defined Cut-off Values | Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL. | One month after the hepatitis B vaccine 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 | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Poovorawan Y et al. Persistence of anti-HBs antibodies and immune memory 20-years after hepatitis B vaccination among children in Thailand. Abstract presented at the 9th International Congress of Tropical Pediatrics (ICTP). Bangkok, Thailand. 18-20 October 2011. | ||
| 23732904 | Derived | Poovorawan Y, Chongsrisawat V, Theamboonlers A, Crasta PD, Messier M, Hardt K. Long-term anti-HBs antibody persistence following infant vaccination against hepatitis B and evaluation of anamnestic response: a 20-year follow-up study in Thailand. Hum Vaccin Immunother. 2013 Aug;9(8):1679-84. doi: 10.4161/hv.24844. Epub 2013 May 31. |
| 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 |
|---|---|---|---|
| 110071 | 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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Subjects who received primary neonatal Engerix™-B vaccination 20 years ago in the 103860/272 primary study and who had anti-hepatitis B surface antigen (HBs) antibody concentrations < 100 milli-international units per milliliter (mIU/ml) at the previous available long-term time-point (NCT00240539), were invited to participate in the current study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Engerix Group | Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Engerix Group | Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B). |
| 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 an Immune Response to a Challenge Dose of Hepatitis B Vaccine | Immune response to a challenge dose of hepatitis B vaccine is defined as
| Posted | Number | subjects | One month after the hepatitis B vaccine 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 | Engerix Group | Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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Concentrations are given as Geometric Mean Concentrations (GMCs), calculated on subjects seropositive (subjects with anti-HBs antibody concentrations ≥ 3.3 mIU/mL) post-challenge dose. |
| One month after the hepatitis B vaccine challenge dose |
| Number of Subjects Reporting Unsolicited Adverse Events | An adverse event 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 after the challenge dose of hepatitis B vaccine |
| Number of Subjects Reporting Serious Adverse Events | A serious adverse event 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 after the challenge dose of hepatitis B vaccine |
For additional information about this study please refer to the GSK Clinical Study Register |
| 110071 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110071 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110071 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110071 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110071 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| years |
|
| Gender | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Number of Subjects With Anti-HBs Antibody Concentrations Above Pre-defined Cut-off Values | Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL. | Posted | Number | subjects | One month after the hepatitis B vaccine challenge dose |
|
|
|
| Secondary | Concentration of Anti-HBs Antibodies | Concentrations are given as Geometric Mean Concentrations (GMCs), calculated on subjects seropositive (subjects with anti-HBs antibody concentrations ≥ 3.3 mIU/mL) post-challenge dose. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | One month after the hepatitis B vaccine challenge dose |
|
|
|
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events | An adverse event 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. | Posted | Number | subjects | During the 31-day follow-up period after the challenge dose of hepatitis B vaccine |
|
|
|
| Secondary | Number of Subjects Reporting Serious Adverse Events | A serious adverse event 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. | Posted | Number | subjects | During the 31-day follow-up period after the challenge dose of hepatitis B vaccine |
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|
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| 0 |
| 29 |
| 0 |
| 29 |
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 |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |