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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-003299-40 | EudraCT Number |
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Evaluate the immune response of GSK Biologicals' 10-valent pneumococcal conjugate vaccine one month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months of age
Test groups: 2 groups (60 subjects/group). 10Pn-PD-DiT group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib; Control group receiving Prevenar + DTPa-HBV-IPV/Hib
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal (vaccine) | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| 1 month post-dose 3: Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 µg/mL |
| Measure | Description | Time Frame |
|---|---|---|
| 1 month post dose 3: For all vaccine pneumococcal serotypes: Opsono titres | ||
| Antibody (Ab) concns >= 0.05 µg/mL | ||
| Ab concns to protein D and seropositivity (S+) status |
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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 | 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 |
|---|---|
| Booster Study | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 105554 | Study Protocol | View IPD |
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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| S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine |
| After each vaccination, occurrence of: solicited local, general symptoms within 4 days |
| Unsolicited adverse events within 31 days, SAEs (whole study period) |
| 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 | Gerolstein | Rhineland-Palatinate | 54568 | 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 | Bad Lobenstein | Thuringia | 07356 | Germany |
| GSK Investigational Site | Neuhaus am Rennweg | Thuringia | 98724 | Germany |
| GSK Investigational Site | Weimar | Thuringia | 99425 | Germany |
| GSK Investigational Site | Berlin | 10315 | Germany |
| GSK Investigational Site | Berlin | 12627 | Germany |
| GSK Investigational Site | Berlin | 12679 | Germany |
| GSK Investigational Site | Berlin | 13055 | Germany |
| GSK Investigational Site | Berlin | 13409 | Germany |
| GSK Investigational Site | Berlin | 14197 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 105554 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105554 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105554 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105554 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105554 | Individual Participant Data Set | 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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