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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

675 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-03

Study Completion Date

2015-03-07

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Herpes Zoster

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Low potency of NBP608

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

Group Type EXPERIMENTAL

NBP608

Intervention Type BIOLOGICAL

Preparation of Oka/SK strain of live, attenuated zoster virus

High potency of NBP608

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

Group Type EXPERIMENTAL

NBP608

Intervention Type BIOLOGICAL

Preparation of Oka/SK strain of live, attenuated zoster virus

Zostavax

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

Group Type ACTIVE_COMPARATOR

Zostavax

Intervention Type BIOLOGICAL

Preparation of Oka/Merck strain of live, attenuated zoster virus

Interventions

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NBP608

Preparation of Oka/SK strain of live, attenuated zoster virus

Intervention Type BIOLOGICAL

Zostavax

Preparation of Oka/Merck strain of live, attenuated zoster virus

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes