NCT03121638

Safety Study of NBP608 in Healthy Adult Volunteers

An Open Label, Active Controlled, Parallel Group Phase I Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of NBP608 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: SK Chemicals Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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

Detailed description

This is a single-center, open label, active controlled, dose-escalation, parallel group study to assess the safety, tolerability and immunogenicity of NBP608 in healthy adult volunteers. Total of 150 healthy subjects aged 20 and over are enrolled, and each subject is administered with single dose of vaccine which is sequentially assigned to active group 1, 2 and study group 1\~3 in 1:1:1:1:1 ratio(30 subjects are enrolled at each groups) .

Conditions

• Varicella Zoster
• Immunization; Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-02-01
• Completion: 2013-03-01
• First posted: 2017-04-20
• Last updated: 2017-04-20

Locations

1 site across 1 country: South Korea