Safety Study of NBP608 in Healthy Adult Volunteers
NCT03121638 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2017-04-20
Summary
* Indication: Protection against varicella and herpes zoster
* Study Objectives
* Primary: Safety and tolerability assessment after single dose administration of NBP608
* Secondary: immunogenicity assessment after single dose administration of NBP608
Conditions
- Varicella Zoster
- Immunization; Infection
Interventions
- BIOLOGICAL
-
VARIVAX
Preparation of Oka/Merck strain of live, attenuated varicella zoster virus
- BIOLOGICAL
-
ZOSTAVAX
Preparation of Oka/Merck strain of live, attenuated varicella zoster virus
- BIOLOGICAL
-
NBP6081
Preparation of Oka/SK strain of live, attenuated varicella zoster virus
- BIOLOGICAL
-
NBP6082
Preparation of Oka/SK strain of live, attenuated varicella zoster virus
- BIOLOGICAL
-
NBP6083
Preparation of Oka/SK strain of live, attenuated varicella zoster virus
Sponsors & Collaborators
-
SK Chemicals Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Hee-jin Cheong · Korea University Guro Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-11-30
- Primary Completion
- 2013-02-28
- Completion
- 2013-03-31
Countries
- South Korea
Study Locations
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