Herpes Zoster Clinical Trial
Official title:
A Randomized, Double Blinded, Multi-center Phase III Confirmatory 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 824 healthy subjects (412 subjects per treatment arm) 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 824 healthy subjects aged 50 and over are enrolled,
and each subject is administered with single dose of vaccine which is randomly assigned in
1:1 ratio. Stratified randomization for age group is used to achieve the balance of
treatment assignment within age strata.
Total of five visits are scheduled including two visits via telephone contact. Blood
sampling is conducted for immunogenicity assessment before and 6 weeks after vaccination at
Visit 2 and Visit 4 respectively. Safety is monitored 1 week, 6 weeks and 26 weeks after
vaccination through Visit 3*, Visit 4 and Visit 5* (* telephone contact)
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