A Study of ProQuad™ in Healthy Children in Korea (V221-023)

A Multicenter, Randomized, Open-Label Study to Compare the Immunogenicity, Safety, and Tolerability of Measles, Mumps, Rubella, and Varicella of Combination Vaccine ProQuad With Concomitant Administration of M-M-R II and VARIVAX in Healthy Korean Children

This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™ with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after vaccination with ProQuad™ will be non-inferior to the antibody response rates after vaccination with concomitant M-M-R™ II and Varivax™.

Inclusion Criteria:

• Subject is in good health
• Subject has a negative clinical history for measles, mumps, rubella, varicella and zoster

Exclusion Criteria:

• Subject has previously received measles, mumps, rubella and/or varicella vaccine, either alone or in any combination
• Subject has any congenital or acquired immune deficiency, neoplastic disease or depressed immunity
• Subject has a history of seizure disorder
• Subject had exposure to measles, mumps, rubella, varicella and/or zoster in the last 4 weeks
• Subject has received an inactivated vaccine within the past 14 days
• Subject has received a live vaccine within the past 30 days
• Subject has received immune globulin within the past 5 months
• Subject has a recent history of fever (within the last 72 hours)