Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Engerix | Experimental | Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engerix™-B Kinder | Biological | Intramuscular injection, 1 dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value | Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL) | One month after the challenge dose of HBV vaccine |
| 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 | Before challenge dose of HBV vaccine |
| Number of Participants Reporting Solicited Local Symptoms |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birkenfeld | Baden-Wurttemberg | 75217 | Germany | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22508412 | Derived | Behre U, Bleckmann G, Crasta PD, Leyssen M, Messier M, Jacquet JM, Hardt K. Long-term anti-HBs antibody persistence and immune memory in children and adolescents who received routine childhood hepatitis B vaccination. Hum Vaccin Immunother. 2012 Jun;8(6):813-8. doi: 10.4161/hv.19898. Epub 2012 Apr 17. |
| 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 |
|---|---|---|---|
| 110474 | Study Protocol | 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.
Not provided
Not provided
Not provided
Not provided
Not provided
One additional subject, enrolled but not vaccinated, was not included in the number of subjects under "STARTED"
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group Engerix | Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Solicited local symptoms assessed include pain, redness and swelling |
| During the 4-day follow-up period after the challenge dose of HBV vaccine. |
| 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 after the challenge dose of HBV vaccine. |
| Number of Participants 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 HBV vaccine. |
| 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. | After the challenge dose of HBV vaccine. |
| Ettenheim |
| Baden-Wurttemberg |
| 77955 |
| Germany |
| GSK Investigational Site | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| GSK Investigational Site | Karlsruhe | Baden-Wurttemberg | 76189 | Germany |
| GSK Investigational Site | Oberkirch | Baden-Wurttemberg | 77704 | Germany |
| GSK Investigational Site | Oberstenfeld | Baden-Wurttemberg | 71720 | Germany |
| GSK Investigational Site | Offenburg | Baden-Wurttemberg | 77654 | Germany |
| GSK Investigational Site | Pforzheim | Baden-Wurttemberg | 75172 | Germany |
| GSK Investigational Site | Stuttgart | Baden-Wurttemberg | 70469 | Germany |
| GSK Investigational Site | Tuttlingen | Baden-Wurttemberg | 78532 | Germany |
| GSK Investigational Site | Bindlach | Bavaria | 95463 | Germany |
| GSK Investigational Site | Kaufering | Bavaria | 86916 | Germany |
| GSK Investigational Site | Lohr | Bavaria | 97816 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81241 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81735 | Germany |
| GSK Investigational Site | Tegernsee | Bavaria | 83684 | Germany |
| GSK Investigational Site | Löhne | North Rhine-Westphalia | 32584 | Germany |
| GSK Investigational Site | Minden | North Rhine-Westphalia | 32427 | Germany |
| GSK Investigational Site | Münster | North Rhine-Westphalia | 48163 | Germany |
| GSK Investigational Site | Porta Westfalica | North Rhine-Westphalia | 32457 | Germany |
| GSK Investigational Site | Frankenthal | Rhineland-Palatinate | 67227 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55131 | Germany |
| GSK Investigational Site | Trier | Rhineland-Palatinate | 54294 | Germany |
| GSK Investigational Site | Worms | Rhineland-Palatinate | 67547 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04103 | Germany |
| GSK Investigational Site | Bredstedt | Schleswig-Holstein | 25821 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24937 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24943 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24944 | Germany |
| GSK Investigational Site | Husum | Schleswig-Holstein | 25813 | Germany |
| GSK Investigational Site | Kiel | Schleswig-Holstein | 24161 | Germany |
| GSK Investigational Site | Berlin | 10967 | Germany |
| GSK Investigational Site | Berlin | 12679 | Germany |
| GSK Investigational Site | Berlin | 13055 | Germany |
| GSK Investigational Site | Berlin | 13507 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 110474 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110474 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110474 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110474 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110474 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110474 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group Engerix | Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value | Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL) | 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 of HBV vaccine |
|
|
| ||||||||||||||||||||||||||
| 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 subjects from the According-to-Protocol cohort for analysis of antibody persistence for whom serological results were available at pre-HBV vaccine challenge blood sampling time point | Posted | Count of Participants | Participants | Before challenge dose of HBV vaccine |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling | Posted | Count of Participants | Participants | During the 4-day follow-up period after the challenge dose of HBV vaccine. |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Solicited General Symptoms | Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache | Posted | Count of Participants | Participants | During the 4-day follow-up period after the challenge dose of HBV vaccine. |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants 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 | Count of Participants | Participants | During the 31-day follow-up period after the challenge dose of HBV vaccine. |
|
| ||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | After the challenge dose of HBV vaccine. |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group Engerix | Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine) | 0 | 300 | 1 | 300 | 159 | 300 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Concussion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment |
| ||
| Redness | General disorders | Systematic Assessment |
| ||
| Swelling | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Gastrointestinal | 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.
| 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 |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Pain |
| |||||
| Redness |
| |||||
| Swelling |
|
| Title | Denominators | Categories |
|---|
| Fatigue |
| |||||
| Fever (Axillary) |
| |||||
| Gastrointestinal |
| |||||
| Headache |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|