drugset / Trial / NCT03116594

Immunogenicity and Safety of Two Lots of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over

NCT03116594

Phase 2/3 Completed 675 enrolled SK Chemicals Co., Ltd.
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

EvaluationDrugModalityDoseRoute
Subject NBP608 Vaccine 0.5 ml Subcutaneous
Comparator Varivax Vaccine 0.65 ml Subcutaneous

Indications