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

NCT03120364 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 824

Last updated 2017-04-19

No results posted yet for this study

Summary

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.

Conditions

  • Herpes Zoster

Interventions

BIOLOGICAL

NBP608

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

BIOLOGICAL

Zostavax

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

Sponsors & Collaborators

  • SK Chemicals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hee-Jin Cheong, Ph.D · Korea University Guro Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-09
Primary Completion
2015-12-16
Completion
2016-04-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03120364 on ClinicalTrials.gov