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

SK chemicals

Status and phase

Completed

Phase 3

Conditions

Herpes Zoster

Treatments

Biological: Zostavax

Biological: NBP608

Study type

Interventional

Funder types

Industry

Identifiers

NCT03120364

NBP608_HZ_III_2015

Details and patient eligibility

About

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.

Full description

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)

Enrollment

824 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy adult over aged 50 years
Menopause females or females who are confirmed to be negative in a preganacy test on the day of screening and agree to practice birth control for 6 weeks after signing informed concent

Exclusion criteria

Those with hypersensitivity to any component of IP(Investigational Product), such as gelatin
Those with a history of hypersensitivity to vaccination, such as Guillain-Barre syndrome
Those who have received antiviral agents witin 1 month prior to IP vaccination (topical antiviral agent is allowed)
Those who have previously received herpes zoster vaccine
Those who have a history of herpes zoster
Those with congenital or acquired immunodeficiency
Those with active untreated tuberculosis
Those who have received blood products or immunoglobulin within 3 months prior to IP(Investigational Products) vaccination
Those who have received other IPs(Investigational Products) in another clinical study witin 4 weeks prior to IP vaccination in this study