- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03114982
The Evaluation of Immunogenicity and Safety of NBP608 in Healthy Children 12 Months to 12 Years of Age
Randomized, Double-blinded, Parallel-group, Exploratory Study to Assess The Immunogenicity and Safety of NBP608 and Varivax in Healthy Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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)
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Metro Manila
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Muntinlupa City, Metro Manila, Philippines, 1781
- Research Insitute for Torpical Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
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Preparation of the Oka/SK strain of live, attenuated varicella virus
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Experimental: 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
|
Preparation of the Oka/SK strain of live, attenuated varicella virus
|
Experimental: 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
|
Preparation of the Oka/SK strain of live, attenuated varicella virus
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Active Comparator: Varivax
Single dose 0.5mL of Varivax by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh
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Preparation of the Oka/Merck strain of live, attenuated varicella virus
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seroconversion rate measured by FAMA(Fluorescent Antibody to Membrane Antigen) assay
Time Frame: 6 weeks after IP(Investigational Product) vaccination
|
*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
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6 weeks after IP(Investigational Product) vaccination
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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
Time Frame: 6 weeks after IP(Investigational Product) vaccination
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6 weeks after IP(Investigational Product) vaccination
|
|
VZV (Varicella Zoster Virus) antibody GMT (Geometric Mean Titer) measured by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay)
Time Frame: 6 weeks after IP(Investigational Product) vaccination
|
6 weeks after IP(Investigational Product) vaccination
|
|
Seroconversion rate measured by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay)
Time Frame: 6 weeks after IP(Investigational Product) vaccination
|
*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
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6 weeks after IP(Investigational Product) vaccination
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria Rosario Z. capeding, Dr, Research Institute for Tropical Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NBP608_VZ_II_2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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