Immunogenicity and Safety 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

824 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-09

Study Completion Date

2016-04-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03116594

Herpes Zoster

COMPLETED PHASE2/PHASE3

Safety Study of NBP608 in Healthy Adult Volunteers

NCT03121638

Varicella Zoster Immunization; Infection

COMPLETED PHASE1

Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years

NCT00802464

Herpes Zoster

COMPLETED PHASE2

Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older

NCT01165177

Herpes Zoster

COMPLETED PHASE3

ZOSTAVAX™ Safety and Immunogenicity in Korean Adults (V211-034)

NCT01556451

Herpes Zoster Shingles

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Herpes Zoster

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NBP608

Single dose 0.5mL 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 of 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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes