drugset / Trial / NCT03114943
Immunogenicity and Safety of NBP608 Compared to Varivax in Healthy Children 12 Months to 12 Years of Age
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NBP608 | Vaccine | 0.5 ml | Subcutaneous |
| Comparator | Varivax | Vaccine | 0.5 ml | Subcutaneous |