Herpes Zoster Clinical Trial
Official title:
A Randomized, Double Blinded, Multi-center Phase III Confirmatory Study to Assess the Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over
Verified date | April 2017 |
Source | SK Chemicals Co.,Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 824 |
Est. completion date | April 28, 2016 |
Est. primary completion date | December 16, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Healthy adult over aged 50 years - Menopause females or females who are confirmed to be negative in a preganacy test on the day of screening and agree to practice birth control for 6 weeks after signing informed concent Exclusion Criteria: - Those with hypersensitivity to any component of IP(Investigational Product), such as gelatin - Those with a history of hypersensitivity to vaccination, such as Guillain-Barre syndrome - Those who have received antiviral agents witin 1 month prior to IP vaccination (topical antiviral agent is allowed) - Those who have previously received herpes zoster vaccine - Those who have a history of herpes zoster - Those with congenital or acquired immunodeficiency - Those with active untreated tuberculosis - Those who have received blood products or immunoglobulin within 3 months prior to IP(Investigational Products) vaccination - Those who have received other IPs(Investigational Products) in another clinical study witin 4 weeks prior to IP vaccination in this study |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea University Guro Hospital | Seoul | Guro-gu |
Lead Sponsor | Collaborator |
---|---|
SK Chemicals Co.,Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | GMR(Geometric Mean Ratio) of VZV(Varicella-Zoster Virus) antibody titer measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay) | The geometric mean fold rise of subjects' VZV(Varicella zoster virus) antibody titers of NBP608 from prevaccination to 6weeks postvaccination | 6 weeks after IP(Investigational Product) vaccination | |
Primary | GMR(Geometric Mean Ratio) ratio of NBP608 to Zostavax measured by gpELISA | Non-inferiority assessment by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax | 6 weeks after IP(Investigational Product) vaccination | |
Secondary | VZV-CMI(Varicella Zoster Virus-Cell Mediated Immnogenicity) response measured by IFN-?(Interferon-gamma) ELISPOT (Enzyme-Linked Immunospot) | 6 weeks after IP(Investigational Product) vaccination | ||
Secondary | VZV-CMI(Varicella Zoster Virus-Cell Mediated Immnogenicity) response measured by IL-2(Interleukin-2) ELISPOT (Enzyme-Linked Immunospot) | 6 weeks after IP(Investigational Product) vaccination |
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