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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
330
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
PCV7 (0.5 ml) to be administered in the right thigh muscle
MenC-TT vaccine (0.5 ml) to be administered in the left thigh muscle
Werderstrasse 3
Bad Saulgau, Baden-Wurttemberg, Germany
Hauptstrasse 9
Bietigheim-Bissingen, Baden-Wurttemberg, Germany
Kirchstrasse 2
Bönnigheim, Baden-Wurttemberg, Germany
Winckelhoferstrasse 3
Ehingen, Baden-Wurttemberg, Germany
Rheinstrasse 13
Ettenheim, Baden-Wurttemberg, Germany
Hauptstrasse 240
Kehl, Baden-Wurttemberg, Germany
Schwarzwaldstrasse 20
Kirchzarten, Baden-Wurttemberg, Germany
Bismarkstrasse 3
Ludwigsburg, Baden-Wurttemberg, Germany
Flattichstrasse 29
Ludwigsburg, Baden-Wurttemberg, Germany
Wilhelmstrasse 25
Metzingen, Baden-Wurttemberg, Germany
...and 17 more locations
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
Time frame: 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
Time frame: 1 month after administration of MenC-TT vaccine
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