Infections, Meningococcal Clinical Trial
Official title:
Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-Administered With GSK Biologicals' MMRV Vaccine (Priorix-Tetra™) in Healthy 12 to 23-Month-Old Children
The purpose of this study is to demonstrate, in 12-23 month old children, the non-inferiority
of the meningococcal vaccine 134612 given with Priorix-Tetra.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
Open multicentre study with 4 treatment groups. Two groups will receive the 134612 vaccine
with Priorix-Tetra either at the same or different visits followed by a second Priorix-Tetra
vaccination at 84 days.
Two control groups will receive Priorix-Tetra and Meningitec at different visits followed by
a second Priorix-Tetra vaccination at 84 days.
For all subjects, two blood samples will be taken: prior to and 42 days after the first
vaccination. In a subset (30% of subjects in Groups A en C) from selected study centres:
additional sample 42 days after second Priorix-Tetra dose.
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