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

Primary Purpose

Varicella

Status
Completed
Phase
Phase 2
Locations
Philippines
Study Type
Interventional
Intervention
NBP608
Varivax
Sponsored by
SK Chemicals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Varicella focused on measuring Prevention of varicella, Varicella-zoster vaccine

Eligibility Criteria

12 Months - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Research Insitute for Torpical Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Low potency of NBP608

Middle potency of NBP608

High potency of NBP608

Varivax

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

VZV (Varicella Zoster Virus) antibody GMT (Geometric Mean Titer) measured by FAMA(Fluorescent Antibody to Membrane Antigen) assay
VZV (Varicella Zoster Virus) antibody GMT (Geometric Mean Titer) measured by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay)
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

Full Information

First Posted
April 11, 2017
Last Updated
April 11, 2017
Sponsor
SK Chemicals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03114982
Brief Title
The Evaluation of Immunogenicity and Safety of NBP608 in Healthy Children 12 Months to 12 Years of Age
Official Title
Randomized, Double-blinded, Parallel-group, Exploratory Study to Assess The Immunogenicity and Safety of NBP608 and Varivax in Healthy Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Chemicals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella
Keywords
Prevention of varicella, Varicella-zoster vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low potency of NBP608
Arm Type
Experimental
Arm Description
Single dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh
Arm Title
Middle potency of NBP608
Arm Type
Experimental
Arm Description
Single dose 0.5mL of middle potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh
Arm Title
High potency of NBP608
Arm Type
Experimental
Arm Description
Single dose 0.5mL of high potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh
Arm Title
Varivax
Arm Type
Active Comparator
Arm Description
Single dose 0.5mL of Varivax by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh
Intervention Type
Biological
Intervention Name(s)
NBP608
Intervention Description
Preparation of the Oka/SK strain of live, attenuated varicella virus
Intervention Type
Biological
Intervention Name(s)
Varivax
Intervention Description
Preparation of the Oka/Merck strain of live, attenuated varicella virus
Primary Outcome Measure Information:
Title
Seroconversion rate measured by FAMA(Fluorescent Antibody to Membrane Antigen) assay
Description
*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
Time Frame
6 weeks after IP(Investigational Product) vaccination
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Seroconversion rate measured by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay)
Description
*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
Time Frame
6 weeks after IP(Investigational Product) vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Rosario Z. capeding, Dr
Organizational Affiliation
Research Institute for Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Insitute for Torpical Medicine
City
Muntinlupa City
State/Province
Metro Manila
ZIP/Postal Code
1781
Country
Philippines

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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