drugset / Trial / NCT03114943

Immunogenicity and Safety of NBP608 Compared to Varivax in Healthy Children 12 Months to 12 Years of Age

NCT03114943

Phase 3 Completed 516 enrolled SK Bioscience Co., Ltd.
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study assesses non-inferiority by comparing seroconversion rate of NBP608 to Varivax which are indicated for active immunization for prevention of varicella. Total of 488 subjects (244 subjects per 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
2016-07-14
Primary completion
2017-06-28
Completion
2017-06-28

Drugs

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

Indications