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

SK chemicals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Herpes Zoster

Treatments: Biological: Zostavax; Biological: NBP608

Study type: Interventional

Funder types: Industry

Identifiers

NCT03116594

NBP608_HZ_III_2013

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 646 healthy subjects 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 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)

Enrollment: 675 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 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 screening visit
• Those who have received other IPs(Investigational Products) in another clinical study witin 4 weeks prior to IP vaccination in this study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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675 participants in 3 patient groups

Low potency of NBP608

Experimental group

Description:

Single dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm

Treatment:

Biological: NBP608

High potency of NBP608

Experimental group

Description:

Single dose 0.5mL of high potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm

Treatment:

Biological: NBP608

Zostavax

Active Comparator group

Description:

Single dose 0.65mL Zostavax by subcutaneous injection into the outer aspect of the upper arm

Treatment:

Biological: Zostavax