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Persistence of seroprotective antibody concentrations & immunological memory shown by the ability to mount a response to a challenge dose of HBV vaccine
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hepatitis B vaccine | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs antibody concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Persistence of antibodies to the other DTPa-HBV-IPV/Hib vaccine antigens. | ||
| Sol & unsol symptoms after HBV vaccination, SAEs |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ettenheim | Baden-Wurttemberg | 77955 | Germany | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20009522 | Derived | Zinke M, Disselhoff J; DTP a-HBV-IPV-110 and -111 study groups; Gartner B, Jacquet JM. Immunological persistence in 4-6 and 7-9 year olds previously vaccinated in infancy with hexavalent DTPa-HBV-IPV/Hib. Hum Vaccin. 2010 Feb;6(2):189-93. doi: 10.4161/hv.6.2.10117. |
| 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 |
|---|---|---|---|
| 106744 | 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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| Kehl |
| Baden-Wurttemberg |
| 77694 |
| Germany |
| GSK Investigational Site | Oberkirch | Baden-Wurttemberg | 77704 | Germany |
| GSK Investigational Site | Offenburg | Baden-Wurttemberg | 77654 | Germany |
| GSK Investigational Site | Aichach | Bavaria | 86551 | Germany |
| GSK Investigational Site | Bobingen | Bavaria | 86399 | Germany |
| GSK Investigational Site | Erding | Bavaria | 85435 | Germany |
| GSK Investigational Site | Kaufering | Bavaria | 86916 | Germany |
| GSK Investigational Site | Kempten (Allgäu) | Bavaria | 87435 | Germany |
| GSK Investigational Site | Landsberg am Lech | Bavaria | 86899 | Germany |
| GSK Investigational Site | Lohr | Bavaria | 97816 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81241 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81243 | Germany |
| GSK Investigational Site | Nördlingen | Bavaria | 86720 | Germany |
| GSK Investigational Site | Pegnitz | Bavaria | 91257 | Germany |
| GSK Investigational Site | Tutzing | Bavaria | 82327 | Germany |
| GSK Investigational Site | Weilheim | Bavaria | 82362 | Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 22415 | Germany |
| GSK Investigational Site | Marburg/Lahn | Hesse | 35039 | Germany |
| GSK Investigational Site | Salzgitter | Lower Saxony | 38226 | Germany |
| GSK Investigational Site | Erkrath | North Rhine-Westphalia | 40699 | Germany |
| GSK Investigational Site | Krefeld | North Rhine-Westphalia | 47798 | Germany |
| GSK Investigational Site | Willich | North Rhine-Westphalia | 47877 | Germany |
| GSK Investigational Site | Bad Sobernheim | Rhineland-Palatinate | 55566 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55131 | Germany |
| GSK Investigational Site | Schoeneberg - Kuebelberg | Rhineland-Palatinate | 66901 | Germany |
| GSK Investigational Site | Trier | Rhineland-Palatinate | 54290 | Germany |
| GSK Investigational Site | Bischofswerda | Saxony | 01877 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01307 | Germany |
| GSK Investigational Site | Altenholz | Schleswig-Holstein | 24161 | Germany |
| GSK Investigational Site | Bredstedt | Schleswig-Holstein | 25821 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24937 | 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 | Niebüll | Schleswig-Holstein | 25899 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10249 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10999 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13355 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13507 | Germany |
| GSK Investigational Site | Bad Lobenstein | Thuringia | 07356 | Germany |
| GSK Investigational Site | Rudolstadt | Thuringia | 07407 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 106744 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106744 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106744 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106744 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106744 | Dataset Specification | 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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| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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