drugset / Trial / NCT03116594
Immunogenicity and Safety of Two Lots of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over
RandomizedParallel-groupDouble-blindPrevention
Summary
This study assesses non-inferiority by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax which are evaluated by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay). Total of 646 healthy subjects aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.
Timeline
- Start
- 2014-01-03
- Primary completion
- 2014-04-08
- Completion
- 2015-03-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NBP608 | Vaccine | 0.5 ml | Subcutaneous |
| Comparator | Varivax | Vaccine | 0.65 ml | Subcutaneous |