Study Results
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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COMPLETED
PHASE1
150 participants
INTERVENTIONAL
2012-11-30
2013-03-31
Brief Summary
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* Study Objectives
* Primary: Safety and tolerability assessment after single dose administration of NBP608
* Secondary: immunogenicity assessment after single dose administration of NBP608
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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VARIVAX
Single dose 0.5mL of Varivax by subcutaneous injection into the outer aspect of the upper arm
VARIVAX
Preparation of Oka/Merck strain of live, attenuated varicella zoster virus
ZOSTAVAX
Single dose 0.65mL of Zostavax by subcutaneous injection into the outer aspect of the upper arm
ZOSTAVAX
Preparation of Oka/Merck strain of live, attenuated varicella zoster virus
NBP6081
Single dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm
NBP6081
Preparation of Oka/SK strain of live, attenuated varicella zoster virus
NBP6082
Single dose 0.5mL of middle potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm
NBP6082
Preparation of Oka/SK strain of live, attenuated varicella zoster virus
NBP6083
Single dose 0.5mL of high potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm
NBP6083
Preparation of Oka/SK strain of live, attenuated varicella zoster virus
Interventions
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VARIVAX
Preparation of Oka/Merck strain of live, attenuated varicella zoster virus
ZOSTAVAX
Preparation of Oka/Merck strain of live, attenuated varicella zoster virus
NBP6081
Preparation of Oka/SK strain of live, attenuated varicella zoster virus
NBP6082
Preparation of Oka/SK strain of live, attenuated varicella zoster virus
NBP6083
Preparation of Oka/SK strain of live, attenuated varicella zoster virus
Eligibility Criteria
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Inclusion Criteria
* Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements
* Female subjects of post-menopausal (amenorrhea for 24 months) whose pregnancy tests was found negative at screening visit
* Subjects of seropositive for Varicella-Zoster virus at screening visit
Exclusion Criteria
* Subjects with a history of vaccination for herpes zoster
* Pregnant or lactating women
* Participants in another clinical study within 4 weeks before vaccination in this study, etc.
20 Years
ALL
Yes
Sponsors
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SK Chemicals Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Hee-jin Cheong
Role: PRINCIPAL_INVESTIGATOR
Korea University Guro Hospital
Locations
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Korea University Guro Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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NBP608_VZ_I_2012
Identifier Type: -
Identifier Source: org_study_id
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