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Three dose primary vaccination with 11-valent pneumococcal conjugate vaccine administered concomitantly with Infanrix™ hexa to healthy infants between 8 to 16 weeks of age at the time of first vaccination.
Test groups: 9 groups receiving different formulations of 11PN-PD-DiT vaccine + DTPa-HBV-IPV/Hib (Infanrix™ hexa) Comparator: 11Pn-PD + Infanrix™ hexa Control: Prevenar® + Infanrix™ hexa
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal (vaccine) | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| 1 month after d3, antibody concentrations to pneumo. serotypes 1,3,4,5,6B,7F,9V,14,18C,19Fand23F.Occurrence of: solicited local and general symptoms within 8 days after each vaccination; unsolicited adverse events within 31 days after each vaccination | 1 Month after dose 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 1 month post d3: For pneumo.serotypes 1,3,4,5,6B,7F, 9V,14,18C,19F,23F:Opsono titres;antibody concentrations (AbC) >= 0.20 µg/mL;AbC to protein D and seropositivity (S+)status; S+/seroprotection status to antigens in Infanrix hexa. | 1 Month after dose 3 |
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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 |
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| 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 |
|---|---|---|---|
| 103488 | Study Protocol | 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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| Bretten |
| Baden-Wurttemberg |
| 75015 |
| Germany |
| GSK Investigational Site | Eppelheim | Baden-Wurttemberg | 69214 | Germany |
| GSK Investigational Site | Ettenheim | Baden-Wurttemberg | 77955 | Germany |
| GSK Investigational Site | Kehl | Baden-Wurttemberg | 77694 | Germany |
| GSK Investigational Site | Oberkirch | Baden-Wurttemberg | 77704 | Germany |
| GSK Investigational Site | Offenburg | Baden-Wurttemberg | 77654 | Germany |
| GSK Investigational Site | Schwäbisch Hall | Baden-Wurttemberg | 74523 | Germany |
| GSK Investigational Site | Stuttgart | Baden-Wurttemberg | 70469 | Germany |
| GSK Investigational Site | Tauberbischofsheim | Baden-Wurttemberg | 97941 | Germany |
| GSK Investigational Site | Cham | Bavaria | 93413 | Germany |
| GSK Investigational Site | Herzogenaurach | Bavaria | 91074 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80939 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81241 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81675 | Germany |
| GSK Investigational Site | Nördlingen | Bavaria | 86720 | Germany |
| GSK Investigational Site | Olching | Bavaria | 82140 | Germany |
| GSK Investigational Site | Weilheim | Bavaria | 82362 | Germany |
| GSK Investigational Site | Zwiesel | Bavaria | 94227 | Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 22307 | Germany |
| GSK Investigational Site | Koenigstein | Hesse | 61462 | Germany |
| GSK Investigational Site | Marburg/Lahn | Hesse | 35039 | Germany |
| GSK Investigational Site | Wiesbaden | Hesse | 65205 | Germany |
| GSK Investigational Site | Salzgitter | Lower Saxony | 38226 | Germany |
| GSK Investigational Site | Wolfenbüttel | Lower Saxony | 38302 | Germany |
| GSK Investigational Site | Rostock | Mecklenburg-Vorpommern | 18059 | Germany |
| GSK Investigational Site | Waren | Mecklenburg-Vorpommern | 17192 | Germany |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44791 | Germany |
| GSK Investigational Site | Detmold | North Rhine-Westphalia | 32756 | Germany |
| GSK Investigational Site | Dortmund | North Rhine-Westphalia | 44329 | Germany |
| GSK Investigational Site | Erkrath | North Rhine-Westphalia | 40699 | Germany |
| GSK Investigational Site | Heiligenhaus | North Rhine-Westphalia | 42579 | Germany |
| GSK Investigational Site | Kleve-Materborn | North Rhine-Westphalia | 47533 | Germany |
| GSK Investigational Site | Krefeld | North Rhine-Westphalia | 47798 | Germany |
| GSK Investigational Site | Löhne | North Rhine-Westphalia | 32584 | Germany |
| GSK Investigational Site | Münster | North Rhine-Westphalia | 48159 | Germany |
| GSK Investigational Site | Bodenheim | Rhineland-Palatinate | 55294 | Germany |
| GSK Investigational Site | Frankenthal | Rhineland-Palatinate | 67227 | Germany |
| GSK Investigational Site | Ludwigshafen am Rhein | Rhineland-Palatinate | 67059 | 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 | Trier | Rhineland-Palatinate | 54294 | Germany |
| GSK Investigational Site | Worms | Rhineland-Palatinate | 67547 | Germany |
| GSK Investigational Site | Bredstedt | Schleswig-Holstein | 25821 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24937 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24939 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24943 | Germany |
| GSK Investigational Site | Flensburg | Schleswig-Holstein | 24944 | Germany |
| GSK Investigational Site | Husum | Schleswig-Holstein | 25813 | Germany |
| GSK Investigational Site | Neumünster | Schleswig-Holstein | 24534 | 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 | 13355 | Germany |
| GSK Investigational Site | Bad Lobenstein | Thuringia | 07356 | Germany |
| GSK Investigational Site | Weimar | Thuringia | 99425 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| 103488 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103488 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103488 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103488 | 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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