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Immunogenicity and Safety of NBP608 Compared to Varivax in Healthy Children 12 Months to 12 Years of Age

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ClinicalTrials.gov Identifier: NCT03114943
Recruitment Status : Unknown
Verified April 2017 by SK Chemicals Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
SK Chemicals Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Varicella Biological: NBP608 Biological: Varivax Phase 3

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 516 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multi-national, Multi-center, Randomized, Double Blinded, Parallel-group Study to Assess the Immunogenicity and Safety of NBP608 Compared to Varivax in Healthy Children 12 Months to 12 Years of Age
Actual Study Start Date : July 2016
Actual Primary Completion Date : February 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chickenpox Shingles

Arm Intervention/treatment
Experimental: NBP608
Single dose 0.5mL of NBP608 by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh
Biological: NBP608
Preparation of the Oka/SK strain of live, attenuated varicella virus

Active Comparator: Varivax
Single dose 0.5mL of Varivax by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh
Biological: Varivax
Preparation of the Oka/Merck strain of live, attenuated varicella virus




Primary Outcome Measures :
  1. seroconversion rate 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


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. seroconversion rate by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay) [ Time Frame: 6 weeks after IP(Investigational Product) vaccination ]
    *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


Other Outcome Measures:
  1. Consistency Assessment between Countries [ Time Frame: 6 weeks after IP(Investigational Product) vaccination ]
    Comparison of seroconversion rate of NBP608 and Comparator in each country by FAMA(Fluorescent Antibody to Membrane Antigen) assay



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Ages Eligible for Study:   12 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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) vaccination 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114943


Locations
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Philippines
De La Salle Health Sciences Institute
Dasmariñas, Cavite, Philippines, 4114
Sponsors and Collaborators
SK Chemicals Co., Ltd.
Investigators
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Principal Investigator: DELIA C. YU, Dr De La Salle Health Sciences Institute

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Responsible Party: SK Chemicals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03114943     History of Changes
Other Study ID Numbers: NBP608_VZ_III_2015
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by SK Chemicals Co., Ltd.:
prevention of varicella
Varicella-zoster vaccine

Additional relevant MeSH terms:
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Chickenpox
Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases