Herpes Zoster Clinical Trial
Official title:
A Multi-center, Randomized, Double Blinded, Parallel-group Study to Assess the Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over
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.
This is a multi-center, randomized, double blinded, parallel-group study to assess the
Immunogenicity and safety of NBP608 compared to Zostavax which are indicated for the
prevention of herpes zoster. 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 to
low, high potency of NBP608 group and Zostavax group in 1:1:2 ratio. Stratified
randomization for age group is used to achieve the balance of treatment assignment within
age strata.
Total of six visits are scheduled including two visits via telephone contact. Blood sampling
is conducted for immunogenicity assessment before and 6 weeks, 52 weeks after vaccination at
Visit 2, Visit 4, Visit 6 respectively. Safety is monitored 1 week, 6 weeks, 26 weeks and 52
weeks after vaccination through Visit 3*, Visit 4, Visit 5*, Visit 6. (* telephone contact)
;
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