The aims of this study are to evaluate the safety and immunogenicity of a booster dose of GSK Biological's candidate Tdap vaccine containing 0.3 mg Al when administered to healthy school children and adolescents (9-13 years of age) previously vaccinated with five consecutive doses of Pa-containing vaccine. The inclusion of hepatitis A vaccine (Havrix®) as a control vaccine enables this study to be conducted in a double-blinded in terms of immunogenicity and safety assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
321
GSK Investigational Site
Kehl, Baden-Wurttemberg, Germany
GSK Investigational Site
Oberkirch, Baden-Wurttemberg, Germany
GSK Investigational Site
Limburg an der Lahn, Hesse, Germany
GSK Investigational Site
Erkrath, North Rhine-Westphalia, Germany
GSK Investigational Site
Krefeld, North Rhine-Westphalia, Germany
GSK Investigational Site
Willich, North Rhine-Westphalia, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, Germany
GSK Investigational Site
Trier, Rhineland-Palatinate, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany
...and 3 more locations
Safety after vaccination.
Immunogenicity and safety after vaccination
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