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The purpose of this study in healthy toddlers who have not previously been immunized against MenC infection and who completed their primary immunization series with PCV-7 (3 vaccinations) during infancy is to demonstrate that the concomitant administration of a single dose of MenC-TT vaccine and a PCV7 booster does not influence the immune response to the seven pneumococcal strains contained in PCV7 as compared to administration of PCV7 alone, and does not influence the immune response to the MenC-TT vaccine as compared to administration of MenC-TT vaccine alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Concomitant administration of MenC-TT vaccine and PCV7, 170 subjects |
|
| 2 | Active Comparator | PCV7 administration only, 85 subjects |
|
| 3 | Active Comparator | MenC-TT vaccine only, 85 subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7) | Biological | MenC-TT vaccine (0.5 ml) to be administered in the left thigh muscle, PCV7 (0.5 ml) to be administered in the right thigh muscle |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects achieving PCV7-specific (elicited by each vaccine pneumococcal serotype) antibody concentrations of at least 0.2 mg/mL 1 month after a booster vaccination with PCV7 | 1 month after booster vaccination with PCV7 | |
| Number of subjects achieving sero-protective levels of meningococcal serogroup C (MenC) specific serum bactericidal activity (SBA), defined as titer >=1:8, 1 month after administration of MenC-TT vaccine | 1 month after administration of MenC-TT vaccine |
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Inclusion Criteria:
Male and female subjects will be eligible for participation in this study if:
Exclusion Criteria:
Subjects will be excluded from participation in this study if:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Werderstrasse 3 | Bad Saulgau | Baden-Wurttemberg | 88348 | Germany | ||
| Hauptstrasse 9 |
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|
|
| 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7) | Biological | PCV7 (0.5 ml) to be administered in the right thigh muscle |
|
|
| Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) | Biological | MenC-TT vaccine (0.5 ml) to be administered in the left thigh muscle |
|
|
| Bietigheim-Bissingen |
| Baden-Wurttemberg |
| 74321 |
| Germany |
| Kirchstrasse 2 | Bönnigheim | Baden-Wurttemberg | 74357 | Germany |
| Winckelhoferstrasse 3 | Ehingen | Baden-Wurttemberg | 89584 | Germany |
| Rheinstrasse 13 | Ettenheim | Baden-Wurttemberg | 77955 | Germany |
| Hauptstrasse 240 | Kehl | Baden-Wurttemberg | 77694 | Germany |
| Schwarzwaldstrasse 20 | Kirchzarten | Baden-Wurttemberg | 79199 | Germany |
| Bismarkstrasse 3 | Ludwigsburg | Baden-Wurttemberg | 71634 | Germany |
| Flattichstrasse 29 | Ludwigsburg | Baden-Wurttemberg | 71642 | Germany |
| Wilhelmstrasse 25 | Metzingen | Baden-Wurttemberg | 72555 | Germany |
| Grossbottwarer Strasse 47 | Oberestenfeld | Baden-Wurttemberg | 71720 | Germany |
| Bergstrasse 27 | Rottweil | Baden-Wurttemberg | 78628 | Germany |
| Königstrasse 35 | Rottweil | Baden-Wurttemberg | 78628 | Germany |
| Crailsheimer Strasse 63 | Schwäbisch Hall | Baden-Wurttemberg | 74523 | Germany |
| Schillerstrasse 11 | Tuttlinger | Baden-Wurttemberg | 78532 | Germany |
| Broner Platz 6 | Weingarten | Baden-Wurttemberg | 88250 | Germany |
| Neuschwansteinstrasse 5 | Augsburg | Bayern (Bavaria) | 86163 | Germany |
| Lehenstrasse 12 | Bindlach | Bayern (Bavaria) | 95463 | Germany |
| Mohrenstrasse 8 | Coburg | Bayern (Bavaria) | 96450 | Germany |
| Bahnhofstrasse 13 | Ebersberg | Bayern (Bavaria) | 85560 | Germany |
| Löpsingerstrasse 8 | Nördlingen | Bayern (Bavaria) | 86720 | Germany |
| Falkensteiner Strasse 24 | Roding | Bayern (Bavaria) | 93426 | Germany |
| Langenbeckstrasse 1 | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Goethestrasse 30 | Arnstadt | Thuringia | 99310 | Germany |
| Schloß-Prunn-Str. 1 | Munich | 81375 | Germany |
| Schwarzwaldstr. 18 | Oberkirch | 77704 | Germany |
| Christofstr.13A | Schwieberdingen | 71701 | Germany |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| ID | Term |
|---|---|
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D017778 | Vaccines, Combined |
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