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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
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03121638
Enrollment
150
Registered
2017-04-20
Start date
2012-11-30
Completion date
2013-03-31
Last updated
2017-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicella Zoster, Immunization; Infection

Keywords

Varicella Vaccine, Herpes Zoster Vaccine

Brief 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) .

Interventions

BIOLOGICALVARIVAX

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

BIOLOGICALZOSTAVAX

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

BIOLOGICALNBP6081

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

BIOLOGICALNBP6082

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

BIOLOGICALNBP6083

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

Sponsors

SK Chemicals Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Healthy adults aged 20 and over * 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

* Patients with herpes zoster * 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.

Design outcomes

Primary

MeasureTime frame
Incidence Rate of Adverse Event42days after Investigation Product Vaccination

Secondary

MeasureTime frame
Varicella Zoster Virus Antibody Titer Measured by FAMA(Fluorescent Antibody to Membrane Antigen)42days after Investigation Product Vaccination
Varicella Zoster Virus Antibody Titer Measured by gpELISA(Glycoprotein Enzyme-Linked Immunosorbent Assay)42days after Investigation Product Vaccination

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026