The purpose of the study is to provide data on the safety and immunogenicity of Pediacel® to allow its use as a fourth dose administered to 11-18 months old toddlers at the same time as Prevenar®. Primary Objective: To evaluate the safety of Pediacel® booster dose co-administered with Prevenar® to toddlers at 11-18 months of age. Secondary Objectives: * To describe the incidence rate of severe fever within four days post-vaccination * To describe the antibody responses to all antigens in a subgroup of subjects at baseline and post-vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
847
0.5 mL, IM
0.5 mL, IM
Unnamed facility
Aalen, Germany
Unnamed facility
Aisch, Germany
Unnamed facility
Alsfeld, Germany
Unnamed facility
Augsburg, Germany
Unnamed facility
Bad Oeynhausen, Germany
Unnamed facility
Bad Säckingen, Germany
To provide information concerning the safety after administration of PEDIACEL® booster dose
Time frame: 0 to 3 Days post-vaccination
To provide information concerning the safety (as fever rate) after administration of PEDIACEL® Vaccine
Time frame: 4 days post-vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Berlin, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Berlin, Germany
...and 74 more locations