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The purpose of this study is to determine at 5 years of age the persistence of immunity to hepatitis B that was conferred by infant vaccination with Infanrix hexa™.
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 |
|---|---|---|---|
| Group A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engerix™-B Kinder | Biological | Intramuscular injection, 1 dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-hepatitis B surface antigen (HBs) antibody concentrations | One month after the challenge dose of HBV vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs antibody concentrations | Before and after challenge dose of HBV vaccine | |
| Occurrence of serious adverse events | During the entire study period. |
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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 | Bad Saulgau | Baden-Wurttemberg | 88348 | Germany | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20078876 | Background | Steiner M, Ramakrishnan G, Gartner B, Van Der Meeren O, Jacquet JM, Schuster V. Lasting immune memory against hepatitis B in children after primary immunization with 4 doses of DTPa-HBV-IPV/Hib in the first and 2nd year of life. BMC Infect Dis. 2010 Jan 15;10:9. doi: 10.1186/1471-2334-10-9. |
| 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 |
|---|---|---|---|
| 106789 | 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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| Bietigheim-Bissingen |
| Baden-Wurttemberg |
| 74321 |
| Germany |
| GSK Investigational Site | Bönnigheim | Baden-Wurttemberg | 74357 | Germany |
| GSK Investigational Site | Ehingen | Baden-Wurttemberg | 89584 | Germany |
| GSK Investigational Site | Ettenheim | Baden-Wurttemberg | 77955 | Germany |
| GSK Investigational Site | Herbolzheim | Baden-Wurttemberg | 79336 | Germany |
| GSK Investigational Site | Kehl | Baden-Wurttemberg | 77694 | Germany |
| GSK Investigational Site | Kirchzarten | Baden-Wurttemberg | 79199 | 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 | Tettnang | Baden-Wurttemberg | 88069 | Germany |
| GSK Investigational Site | Tuttlingen | Baden-Wurttemberg | 78532 | Germany |
| GSK Investigational Site | Aschaffenburg | Bavaria | 63739 | Germany |
| GSK Investigational Site | Cham | Bavaria | 93413 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81241 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81735 | Germany |
| GSK Investigational Site | Nördlingen | Bavaria | 86720 | Germany |
| GSK Investigational Site | Olching | Bavaria | 82140 | Germany |
| GSK Investigational Site | Tegernsee | Bavaria | 83684 | Germany |
| GSK Investigational Site | Dudenhofen | Rhineland-Palatinate | 67373 | Germany |
| GSK Investigational Site | Frankenthal | Rhineland-Palatinate | 67227 | Germany |
| GSK Investigational Site | Gau-Odernheim | Rhineland-Palatinate | 55239 | Germany |
| GSK Investigational Site | Gerolstein | Rhineland-Palatinate | 54568 | Germany |
| GSK Investigational Site | Schoeneberg - Kuebelberg | Rhineland-Palatinate | 66901 | Germany |
| GSK Investigational Site | Trier | Rhineland-Palatinate | 54290 | Germany |
| GSK Investigational Site | Trier | Rhineland-Palatinate | 54294 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04317 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10315 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10967 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 12679 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13055 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13355 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13507 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 14197 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 106789 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106789 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106789 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106789 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106789 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 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 |
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