Varicella Clinical Trial
Official title:
Randomized, Double-blinded, Parallel-group, Exploratory Study to Assess The Immunogenicity and Safety of NBP608 and Varivax in Healthy Children
This study evaluates the immunogenicity and safety of three different potencies of NBP608 and Varivax which are indicated for active immunization for the prevention of varicella. Total of 152 subjects (38 subjects per each treatment arm) of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.
This is a multi-center, randomized, double blinded, active controlled, parallel-group study
to evaluate the immunogenicity and safety of three different potencies of NBP608(low,
middle, high potency) and Varivax which are indicated for active immunization for the
prevention of varicella. Total of 152 subjects (38 subjects per each treatment arm) of 12
months to 12 years of age are enrolled, and each subject is administered with single dose of
vaccine which is randomly assigned in 1:1:1:1 ratio. Stratified randomization for age group
is used to achieve the balance of treatment assignment within age strata.
Total of four visits are scheduled including two visits via telephone contact. Blood
sampling is conducted for immunogenicity assessment before and 6 weeks after vaccination at
Visit 1 and Visit 3 respectively. Safety is monitored 1 week, 6 weeks and 26 weeks after
vaccination through Visit 2*, Visit 3 and Visit 4* (*telephone contact)
;
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