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This study assesses non-inferiority by comparing seroconversion rate of NBP608 to Varivax which are indicated for active immunization for prevention of varicella. Total of 488 subjects (244 subjects per treatment arm) of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.
This is a multi-national, multi-center, randomized, double blinded, parallel-group study to assess the Immunogenicity and safety of NBP608 compared to varivax which are indicated for active immunization for the prevention of varicella. Total of 488 subjects of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned in 1:1 ratio. Stratified randomization for age group is used to achieve the balance of treatment assignment within age strata.
Total of four visits are scheduled including two visits via telephone contact. Blood sampling is conducted for immunogenicity assessment before and 6 weeks after vaccination at Visit 1 and Visit 3 respectively. Safety is monitored 1 week, 6 weeks and 26 weeks after vaccination through Visit 2*, Visit 3 and Visit 4* (* telephone contact)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBP608 | Experimental | Single dose 0.5mL of NBP608 by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh |
|
| Varivax | Active Comparator | Single dose 0.5mL of Varivax by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBP608 | Biological | Preparation of the Oka/SK strain of live, attenuated varicella virus |
| |
| Measure | Description | Time Frame |
|---|---|---|
| seroconversion rate by FAMA (Fluorescent Antibody to Membrane Antigen) assay | *FAMA(Fluorescent Antibody to Membrane Antigen) Seroconversion Rate: the rate of subjects who are converted from seronegative with FAMA(Fluorescent Antibody to Membrane Antigen) VZV(Varicella Zoster Virus) antibody titer < 1:4 before IP(Investigational Product) vaccination to seropositive with FAMA(Fluorescent Antibody to Membrane Antigen) VZV(Varicella Zoster Virus) antibody titer ≥ 1:4 at 6 weeks post-vaccination | 6 weeks after IP(Investigational Product) vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| VZV (Varicella Zoster Virus) antibody GMT(Geometric Mean Titer) measured by FAMA (Fluorescent Antibody to Membrane Antigen) assay | 6 weeks after IP(Investigational Product) vaccination | |
| VZV (Varicella Zoster Virus) antibody GMT(Geometric Mean Titer) measured by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay) |
| Measure | Description | Time Frame |
|---|---|---|
| Consistency Assessment between Countries | Comparison of seroconversion rate of NBP608 and Comparator in each country by FAMA(Fluorescent Antibody to Membrane Antigen) assay | 6 weeks after IP(Investigational Product) vaccination |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| DELIA C. YU, Dr | De La Salle Health Sciences Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| De La Salle Health Sciences Institute | Dasmariñas | Cavite | 4114 | Philippines |
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| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| ID | Term |
|---|---|
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Varivax |
| Biological |
Preparation of the Oka/Merck strain of live, attenuated varicella virus |
|
| 6 weeks after IP(Investigational Product) vaccination |
| seroconversion rate by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay) | *gpELISA(Glycoprotein Enzyme Linked Immunosorbent Assay) Seroconversion Rate : the rate of subjects who are converted from seronegative with < 50mIU/mL before IP(Investigational Product) vaccination to seropositive with ≥ 50mIU/mL at 6 weeks post-vaccination | 6 weeks after IP(Investigational Product) vaccination |
| D007239 | Infections |
| D045424 |
| Complex Mixtures |