The Evaluation of Immunogenicity and Safety of NBP608 in Healthy Children 12 Months to 12 Years of Age

Study Overview
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Brief Summary
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This study evaluates the immunogenicity and safety of three different potencies of NBP608 and Varivax which are indicated for active immunization for the prevention of varicella. Total of 152 subjects (38 subjects per each 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.

Detailed Description
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This is a multi-center, randomized, double blinded, active controlled, parallel-group study to evaluate the immunogenicity and safety of three different potencies of NBP608(low, middle, high potency) and Varivax which are indicated for active immunization for the prevention of varicella. Total of 152 subjects (38 subjects per each 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 in 1:1:1:1 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)

Official Title
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Randomized, Double-blinded, Parallel-group, Exploratory Study to Assess The Immunogenicity and Safety of NBP608 and Varivax in Healthy Children

Conditions
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Varicella

Intervention / Treatment
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* Biological: NBP608
* Biological: Varivax


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children aged between 12 months and 12 years old who are available for the follow-up during the study period After menarche females who are confirmed to be negative in a pregnancy test on the day of vaccination and agree to practice birth control for 3 months after the vaccination Exclusion Criteria: Those with hypersensitivity to any component of the IPs(Investigational Products), such as gelatin or neomycin Those who have received a varicella vaccine previously Those with a history of hypersensitivity to vaccination, such as Guillain-Barre syndrome Those with congenital or acquired immunodeficiency Those with active untreated tuberculosis Those who have received or are expected to receive salicylates from 14 days prior to IP(Investigational Product) vaccination to Visit 3 Those who have received or are expected to receive other vaccines from 1 month prior to IP(Investigational Product) to Visit 3 Those who have received or are expected to receive other IPs(Investigational Products) in another clinical study from 1 month prior to IP(Investigational Product) vaccination to Visit 3

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low potency of NBP608<br>Single dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh | Biological: NBP608<br>* Preparation of the Oka/SK strain of live, attenuated varicella virus<br>|
| Experimental: Middle potency of NBP608<br>Single dose 0.5mL of middle potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh | Biological: NBP608<br>* Preparation of the Oka/SK strain of live, attenuated varicella virus<br>|
| Experimental: High potency of NBP608<br>Single dose 0.5mL of high potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh | Biological: NBP608<br>* Preparation of the Oka/SK strain of live, attenuated varicella virus<br>|
| Active Comparator: Varivax<br>Single dose 0.5mL of Varivax by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh | Biological: Varivax<br>* Preparation of the Oka/Merck strain of live, attenuated varicella virus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate measured 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 6 weeks after IP(Investigational Product) vaccination | 
| Seroconversion rate measured by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay) | *gpELISA Seroconversion Rate : the rate of subjects who are converted from seronegative with < 50mIU/mL before IP vaccination to seropositive with ≥ 50mIU/mL at 6 weeks post-vaccination | 6 weeks after IP(Investigational Product) vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention of varicella, Varicella-zoster vaccine