As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience and improved compliance to vaccination. To account for situations where children have received a first dose of MMR vaccine without varicella, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A second dose of the monovalent varicella vaccine will be given to all children participating to this trial since there is a current debate on the need of a second dose to induce a full protection against varicella.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
446
GSK Investigational Site
Ancenis, France
GSK Investigational Site
Boulogne, France
GSK Investigational Site
Dax, France
GSK Investigational Site
Draguignan, France
GSK Investigational Site
Essey-lès-Nancy, France
GSK Investigational Site
Varicella seroconversion and MMR titres at 42-56 days after first vaccination
Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study)
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Laon, France
GSK Investigational Site
Le Havre, France
GSK Investigational Site
Lingolsheim, France
GSK Investigational Site
Lyon, France
GSK Investigational Site
Nice, France
...and 29 more locations