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To evaluate the immunological memory against pneumococcal vaccine serotypes in children primed with conjugate vaccines by administering a booster dose of plain polysaccharide vaccine.
2 groups (60 per group), booster of Pneumovax 23 after priming with Prevnar or GSK Biologicals' pneumococcal vaccine.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal vaccine | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody concentrations against pneumococcal serotypes 1 month post-booster |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity pre and post-booster and safety (follow up of SAEs) |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mannheim | Baden-Wurttemberg | 68167 | Germany | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21909049 | Background | Knuf M, Pankow-Culot H, Grunert D, Rapp M, Panzer F, Kollges R, Fanic A, Habib A, Borys D, Dieussaert I, Schuerman L. Induction of immunologic memory following primary vaccination with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in infants. Pediatr Infect Dis J. 2012 Jan;31(1):e31-6. doi: 10.1097/INF.0b013e3182323ac2. |
| Label | URL |
|---|---|
| Primary Study | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 106623 | Statistical Analysis Plan | 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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| Marbach |
| Baden-Wurttemberg |
| 71672 |
| Germany |
| GSK Investigational Site | Nördlingen | Bavaria | 86720 | Germany |
| GSK Investigational Site | Tutzing | Bavaria | 82327 | Germany |
| GSK Investigational Site | Wiesbaden | Hesse | 65205 | Germany |
| GSK Investigational Site | Rostock | Mecklenburg-Vorpommern | 18146 | Germany |
| GSK Investigational Site | Waren | Mecklenburg-Vorpommern | 17192 | Germany |
| GSK Investigational Site | Bad Oeynhausen | North Rhine-Westphalia | 32549 | Germany |
| GSK Investigational Site | Erkrath | North Rhine-Westphalia | 40699 | Germany |
| GSK Investigational Site | Goch | North Rhine-Westphalia | 47574 | Germany |
| GSK Investigational Site | Heiligenhaus | North Rhine-Westphalia | 42579 | Germany |
| GSK Investigational Site | Minden | North Rhine-Westphalia | 32427 | Germany |
| GSK Investigational Site | Mönchengladbach | North Rhine-Westphalia | 41061 | Germany |
| GSK Investigational Site | Mönchengladbach | North Rhine-Westphalia | 41236 | Germany |
| GSK Investigational Site | Münster | North Rhine-Westphalia | 48159 | Germany |
| GSK Investigational Site | Oberhausen | North Rhine-Westphalia | 46145 | Germany |
| GSK Investigational Site | Willich | North Rhine-Westphalia | 47877 | 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 | Leipzig | Saxony | 04178 | Germany |
| GSK Investigational Site | Stollberg | Saxony | 09366 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10315 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 12627 | 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 | 14197 | Germany |
| GSK Investigational Site | Bad Lobenstein | Thuringia | 07356 | Germany |
| GSK Investigational Site | Neuhaus am Rennweg | Thuringia | 98724 | Germany |
| GSK Investigational Site | Weimar | Thuringia | 99425 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 106623 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106623 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106623 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106623 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106623 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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