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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-11-30

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.

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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)

Conditions

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Varicella

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low potency of NBP608

Single dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh

Group Type EXPERIMENTAL

NBP608

Intervention Type BIOLOGICAL

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

Middle potency of NBP608

Single dose 0.5mL of middle potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh

Group Type EXPERIMENTAL

NBP608

Intervention Type BIOLOGICAL

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

High potency of NBP608

Single dose 0.5mL of high potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh

Group Type EXPERIMENTAL

NBP608

Intervention Type BIOLOGICAL

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

Varivax

Single dose 0.5mL of Varivax by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh

Group Type ACTIVE_COMPARATOR

Varivax

Intervention Type BIOLOGICAL

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

Interventions

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NBP608

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

Intervention Type BIOLOGICAL

Varivax

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

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

12 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes