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An Open-label, Bridging Study of BARYCELA Inj. in Healthy Vietnamese Children Aged Between 12 Months to 12 Years

Primary Purpose

Varicella Zoster Virus Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MG1111
Sponsored by
GC Biopharma Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Varicella Zoster Virus Infection focused on measuring MG1111, Varicella

Eligibility Criteria

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

Inclusion Criteria: Healthy children aged 12 months to 12 years (inclusive) Subject parent/legal representative willing to provide written informed consent and able to comply with the requirements for the study - Subject able to attend all scheduled visits and to comply with all study procedures Negative history of Varicella and varicella vaccine Subject in good health, based on medical history and physical examination Having a readily identifiable place of residence in the study area, being available for the duration of trial participation, with means of telephone contact. Exclusion Criteria: Subjects who have a history of Varicella or administration of varicella vaccine Subjects who have hypersensitivity reactions to the component of this Investigational Product, such as gelatin Subjects with untreated active tuberculosis Subjects with a history of Guillain-Barre syndrome Subjects who had received salicylates (aspirin, bismuth subsalicylates) within 4 weeks before administration of investigational product or those who are planning to receive salicylates within 42 days after administration of investigational drug. Subjects who administered anti-viral drug within 4 weeks before administration of investigational product or those who are planning to receive anti-viral drug within 42 days after administration of investigational drug. Subjects who have had an acute febrile episode (at least 38.00C) at some time during the 72 hours before administration of investigational product or those who had any symptom suspected to be allergy including systemic rash. Currently receiving or received any investigational intervention within 30 days prior to the vaccination of study vaccine. Subjects who have completed vaccinations within 4 weeks before enrolment or who are planning to administer other vaccines within 42 days after administration of investigational product. Administered any blood product or intravenous immunoglobulin administration within 44 weeks prior to the vaccination of study intervention Currently receiving or anticipate to receive concomitant immunosuppressive or immune-modifying therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or < 2 weeks of daily receipt of prednisone less than 20 mg for subjects who weight more than 10kg and less than 2mg/kg/day for subjects who weight less than 10kg, or equivalent) within 12 weeks prior to the vaccination of study vaccine. Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia. Subject with a history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the study vaccine. Subjects with a severe chronic disease or other clinically significant medical or psychological condition who are considered by the Investigator to be ineligible for the study. Subjects who are pregnant or lactating at the day of screening. Subjects who are planned to participate in another clinical trial during the present trial period.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    MG1111

    Arm Description

    Participants will be administered subcutaneously with a single dose(0.5 mL dose) of the BARYCELA inj.(MG1111) on the upper arm (brachia lateral).

    Outcomes

    Primary Outcome Measures

    Safety of BARYCELA inj.: Solicited local and systemic reactogenicity
    The incidence and severity of immediate solicited local and systemic reactogenicity
    Safety of BARYCELA inj.: The incidence and severity of solicited local and systemic AEs
    The incidence and severity of solicited local and systemic AEs
    Safety of BARYCELA inj.: Incidence and severity of unsolicited AEs
    The incidence and severity of unsolicited AEs
    Safety of BARYCELA inj.: Incidence of adverse event of special interest
    The incidence of AE of Special Interest (AESI): varicella-like rash.
    Safety of BARYCELA inj.: Vital signs
    Vital signs
    Safety of BARYCELA inj.: Body temperature
    Body temperature; measured according to standard of care and thermometer instructions.
    Safety of BARYCELA inj.: Complete physical examination
    Complete physical examination; performed at Screening/Enrollment (Day 0) and Final Visit(Day 42).
    Safety of BARYCELA inj.: Symptom-directed physical examination
    Symptom-directed physical examination (if any symptoms); performed at other timepoints as indicated to assess changes from Screening

    Secondary Outcome Measures

    Immunogenicity of BARYCELA inj.: Geometric Mean Titer (GMT)
    Geometric Mean Titer (GMT) of antibody titer measured with gpELISA
    Immunogenicity of BARYCELA inj.: Geometric Mean Fold Rise (GMFR)
    Geometric Mean Fold Rise (GMFR)

    Full Information

    First Posted
    December 2, 2022
    Last Updated
    December 16, 2022
    Sponsor
    GC Biopharma Corp
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05664152
    Brief Title
    An Open-label, Bridging Study of BARYCELA Inj. in Healthy Vietnamese Children Aged Between 12 Months to 12 Years
    Official Title
    An Open-label, Bridging Study to Assess the Safety and Immunogenicity of BARYCELA Inj. (Live Attenuated Varicella Vaccine for Injection) in Healthy Vietnamese Children Aged Between 12 Months to 12 Years
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2023 (Anticipated)
    Primary Completion Date
    April 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GC Biopharma Corp

    4. Oversight

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

    5. Study Description

    Brief Summary
    The goal of this bridging study is to assess the safety and immunogenicity of BARYCELA inj. in healthy Vietnamese children aged between 12 months to 12 years. The main questions it aims to answer are: Safety of BARYCELA inj. (Live attenuated varicella vaccine for injection) Immunogenicity of BARYCELA inj. (Live attenuated varicella vaccine for injection) Participants will be administered subcutaneously with a single dose(0.5 mL dose) of the BARYCELA inj.(MG1111) on the upper arm (brachia lateral).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Varicella Zoster Virus Infection
    Keywords
    MG1111, Varicella

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    250 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MG1111
    Arm Type
    Experimental
    Arm Description
    Participants will be administered subcutaneously with a single dose(0.5 mL dose) of the BARYCELA inj.(MG1111) on the upper arm (brachia lateral).
    Intervention Type
    Biological
    Intervention Name(s)
    MG1111
    Intervention Description
    BARYCELA inj.
    Primary Outcome Measure Information:
    Title
    Safety of BARYCELA inj.: Solicited local and systemic reactogenicity
    Description
    The incidence and severity of immediate solicited local and systemic reactogenicity
    Time Frame
    within 30-minute post vaccination
    Title
    Safety of BARYCELA inj.: The incidence and severity of solicited local and systemic AEs
    Description
    The incidence and severity of solicited local and systemic AEs
    Time Frame
    during 7 days post vaccination
    Title
    Safety of BARYCELA inj.: Incidence and severity of unsolicited AEs
    Description
    The incidence and severity of unsolicited AEs
    Time Frame
    during 42 days post vaccination
    Title
    Safety of BARYCELA inj.: Incidence of adverse event of special interest
    Description
    The incidence of AE of Special Interest (AESI): varicella-like rash.
    Time Frame
    during 42 days post vaccination
    Title
    Safety of BARYCELA inj.: Vital signs
    Description
    Vital signs
    Time Frame
    Day0(Pre vaccination), 42 days post vaccination
    Title
    Safety of BARYCELA inj.: Body temperature
    Description
    Body temperature; measured according to standard of care and thermometer instructions.
    Time Frame
    Day0(Pre vaccination), 42 days post vaccination
    Title
    Safety of BARYCELA inj.: Complete physical examination
    Description
    Complete physical examination; performed at Screening/Enrollment (Day 0) and Final Visit(Day 42).
    Time Frame
    Day0(Pre vaccination), 42 days post vaccination
    Title
    Safety of BARYCELA inj.: Symptom-directed physical examination
    Description
    Symptom-directed physical examination (if any symptoms); performed at other timepoints as indicated to assess changes from Screening
    Time Frame
    Day0(Pre vaccination), during 42 days post vaccination
    Secondary Outcome Measure Information:
    Title
    Immunogenicity of BARYCELA inj.: Geometric Mean Titer (GMT)
    Description
    Geometric Mean Titer (GMT) of antibody titer measured with gpELISA
    Time Frame
    Prior to IP administration and 42 days post vaccination
    Title
    Immunogenicity of BARYCELA inj.: Geometric Mean Fold Rise (GMFR)
    Description
    Geometric Mean Fold Rise (GMFR)
    Time Frame
    Prior to IP administration and 42 days post 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 12 months to 12 years (inclusive) Subject parent/legal representative willing to provide written informed consent and able to comply with the requirements for the study - Subject able to attend all scheduled visits and to comply with all study procedures Negative history of Varicella and varicella vaccine Subject in good health, based on medical history and physical examination Having a readily identifiable place of residence in the study area, being available for the duration of trial participation, with means of telephone contact. Exclusion Criteria: Subjects who have a history of Varicella or administration of varicella vaccine Subjects who have hypersensitivity reactions to the component of this Investigational Product, such as gelatin Subjects with untreated active tuberculosis Subjects with a history of Guillain-Barre syndrome Subjects who had received salicylates (aspirin, bismuth subsalicylates) within 4 weeks before administration of investigational product or those who are planning to receive salicylates within 42 days after administration of investigational drug. Subjects who administered anti-viral drug within 4 weeks before administration of investigational product or those who are planning to receive anti-viral drug within 42 days after administration of investigational drug. Subjects who have had an acute febrile episode (at least 38.00C) at some time during the 72 hours before administration of investigational product or those who had any symptom suspected to be allergy including systemic rash. Currently receiving or received any investigational intervention within 30 days prior to the vaccination of study vaccine. Subjects who have completed vaccinations within 4 weeks before enrolment or who are planning to administer other vaccines within 42 days after administration of investigational product. Administered any blood product or intravenous immunoglobulin administration within 44 weeks prior to the vaccination of study intervention Currently receiving or anticipate to receive concomitant immunosuppressive or immune-modifying therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or < 2 weeks of daily receipt of prednisone less than 20 mg for subjects who weight more than 10kg and less than 2mg/kg/day for subjects who weight less than 10kg, or equivalent) within 12 weeks prior to the vaccination of study vaccine. Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia. Subject with a history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the study vaccine. Subjects with a severe chronic disease or other clinically significant medical or psychological condition who are considered by the Investigator to be ineligible for the study. Subjects who are pregnant or lactating at the day of screening. Subjects who are planned to participate in another clinical trial during the present trial period.

    12. IPD Sharing Statement

    Learn more about this trial

    An Open-label, Bridging Study of BARYCELA Inj. in Healthy Vietnamese Children Aged Between 12 Months to 12 Years

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