Follow-up to evaluate the immunogenicity and safety of three production lots of GSK Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GSK Biologicals' measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine (Varilrix®) in Germany \& Austria. Blood samples were collected at three time points during the follow-up period (Year 1, 2 \& 3). No new subjects will be enrolled in these follow-up phases of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
398
GSK Investigational Site
Klagenfurt, Austria
GSK Investigational Site
Neufeld/Leitha, Austria
GSK Investigational Site
Salzburg, Austria
GSK Investigational Site
Villach, Austria
GSK Investigational Site
Bindlach, Bavaria, Germany
GSK Investigational Site
Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year
Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination
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Marktredwitz, Bavaria, Germany
GSK Investigational Site
Olching, Bavaria, Germany
GSK Investigational Site
Tegernsee, Bavaria, Germany
GSK Investigational Site
Tutzing, Bavaria, Germany
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, Germany
...and 31 more locations