Hepatitis B Clinical Trial
Official title:
Multicentre Study to Assess Persistence of Antibodies Against Hepatitis B and Immune Response to a Hepatitis B Challenge Dose in Healthy Children 7 to 9 Years Old Previously Vaccinated With 4 Doses of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine
| Verified date | October 2016 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Paul-Ehrlich-Institut |
| Study type | Interventional |
Persistence of seroprotective antibody concentrations & immunological memory shown by the ability to mount a response to a challenge dose of HBV vaccine
| Status | Completed |
| Enrollment | 350 |
| Est. completion date | December 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 7 Years to 9 Years |
| Eligibility |
Inclusion Criteria: - A male or female aged 7 to 9 years at the time of study entry . - Subjects who have received a total of 4 doses of DTPa-HBV-IPV/Hib vaccine or a total of 4 doses of HBV vaccine in previous vaccination studies. - Evidence of previous hepatitis B booster vaccination or disease since administration of the fourth dose of DTPa-HBV-IPV/Hib or HBV vaccine. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Germany | GSK Investigational Site | Aichach | Bayern |
| Germany | GSK Investigational Site | Altenholz | Schleswig-Holstein |
| Germany | GSK Investigational Site | Bad Sobernheim | Rheinland-Pfalz |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Bischofswerda | Sachsen |
| Germany | GSK Investigational Site | Bobingen | Bayern |
| Germany | GSK Investigational Site | Bredstedt | Schleswig-Holstein |
| Germany | GSK Investigational Site | Dresden | Sachsen |
| Germany | GSK Investigational Site | Erding | Bayern |
| Germany | GSK Investigational Site | Erkrath | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Ettenheim | Baden-Wuerttemberg |
| Germany | GSK Investigational Site | Flensburg | Schleswig-Holstein |
| Germany | GSK Investigational Site | Flensburg | Schleswig-Holstein |
| Germany | GSK Investigational Site | Hamburg | |
| Germany | GSK Investigational Site | Husum | Schleswig-Holstein |
| Germany | GSK Investigational Site | Kaufering | Bayern |
| Germany | GSK Investigational Site | Kehl | Baden-Wuerttemberg |
| Germany | GSK Investigational Site | Kempten | Bayern |
| Germany | GSK Investigational Site | Kiel | Schleswig-Holstein |
| Germany | GSK Investigational Site | Krefeld | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Landsberg | Bayern |
| Germany | GSK Investigational Site | Lobenstein | Thueringen |
| Germany | GSK Investigational Site | Lohr | Bayern |
| Germany | GSK Investigational Site | Mainz | Rheinland-Pfalz |
| Germany | GSK Investigational Site | Marburg/Lahn | Hessen |
| Germany | GSK Investigational Site | Muenchen | Bayern |
| Germany | GSK Investigational Site | Muenchen | Bayern |
| Germany | GSK Investigational Site | Niebuell | Schleswig-Holstein |
| Germany | GSK Investigational Site | Noerdlingen | Bayern |
| Germany | GSK Investigational Site | Oberkirch | Baden-Wuerttemberg |
| Germany | GSK Investigational Site | Offenburg | Baden-Wuerttemberg |
| Germany | GSK Investigational Site | Pegnitz | Bayern |
| Germany | GSK Investigational Site | Rudolstadt | Thueringen |
| Germany | GSK Investigational Site | Salzgitter | Niedersachsen |
| Germany | GSK Investigational Site | Schoeneberg - Kuebelberg | Rheinland-Pfalz |
| Germany | GSK Investigational Site | Trier | Rheinland-Pfalz |
| Germany | GSK Investigational Site | Tutzing | Bayern |
| Germany | GSK Investigational Site | Weilheim | Bayern |
| Germany | GSK Investigational Site | Willich | Nordrhein-Westfalen |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Anti-HBs antibody concentration | |||
| Secondary | Persistence of antibodies to the other DTPa-HBV-IPV/Hib vaccine antigens. | |||
| Secondary | Sol & unsol symptoms after HBV vaccination, SAEs |
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