Since measles-mumps-rubella (MMR) and varicella vaccinations are established as routine childhood practice and often co-administered during the second year of life, a combined measles-mumps-rubella-varicella (MeMuRu-OKA) vaccine is fully justified. Such a combined vaccine was developed and extensively studied in susceptible children. In countries where varicella mass-vaccination is already implemented, a transition period is necessary as children who started with separate first-dose vaccinations of MMR and varicella will receive a single shot of the combined vaccine as the second dose. To account for those situations, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of separate MMR and varicella vaccines as a second dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
400
GSK Investigational Site
Edmonton, Alberta, Canada
GSK Investigational Site
Vancouver, British Columbia, Canada
GSK Investigational Site
Halifax, Nova Scotia, Canada
GSK Investigational Site
Enna, Sicily, Italy
GSK Investigational Site
Ragusa, Sicily, Italy
GSK Investigational Site
San Gregorio Di Catania (CT), Sicily, Italy
Varicella, MMR titres at 42-56 days after first vaccination
Seropositivity rates. Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study)
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