drugset / Trial / NCT03114982

The Evaluation of Immunogenicity and Safety of NBP608 in Healthy Children 12 Months to 12 Years of Age

NCT03114982

Phase 2 Completed 152 enrolled SK Chemicals Co., Ltd.
RandomizedParallel-groupQuadruple-blindPrevention

Summary

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.

Timeline

Start
2016-05
Primary completion
2016-07
Completion
2016-11

Drugs

EvaluationDrugModalityDoseRoute
Subject NBP608 Vaccine 0.5 ml Subcutaneous
Comparator Varivax Vaccine 0.5 ml Subcutaneous

Indications