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

December 16, 2022 updated by: GC Biopharma Corp

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy children aged 12 months to 12 years (inclusive)
  2. 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
  3. Negative history of Varicella and varicella vaccine
  4. Subject in good health, based on medical history and physical examination
  5. 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:

  1. Subjects who have a history of Varicella or administration of varicella vaccine
  2. Subjects who have hypersensitivity reactions to the component of this Investigational Product, such as gelatin
  3. Subjects with untreated active tuberculosis
  4. Subjects with a history of Guillain-Barre syndrome
  5. 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.
  6. 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.
  7. 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.
  8. Currently receiving or received any investigational intervention within 30 days prior to the vaccination of study vaccine.
  9. 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.
  10. Administered any blood product or intravenous immunoglobulin administration within 44 weeks prior to the vaccination of study intervention
  11. 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.
  12. Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia.
  13. 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.
  14. 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.
  15. Subjects who are pregnant or lactating at the day of screening.
  16. Subjects who are planned to participate in another clinical trial during the present trial period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MG1111
Participants will be administered subcutaneously with a single dose(0.5 mL dose) of the BARYCELA inj.(MG1111) on the upper arm (brachia lateral).
Biological: MG1111
BARYCELA inj.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety of BARYCELA inj.: Solicited local and systemic reactogenicity
Time Frame: within 30-minute post vaccination
The incidence and severity of immediate solicited local and systemic reactogenicity
within 30-minute post vaccination
Safety of BARYCELA inj.: The incidence and severity of solicited local and systemic AEs
Time Frame: during 7 days post vaccination
The incidence and severity of solicited local and systemic AEs
during 7 days post vaccination
Safety of BARYCELA inj.: Incidence and severity of unsolicited AEs
Time Frame: during 42 days post vaccination
The incidence and severity of unsolicited AEs
during 42 days post vaccination
Safety of BARYCELA inj.: Incidence of adverse event of special interest
Time Frame: during 42 days post vaccination
The incidence of AE of Special Interest (AESI): varicella-like rash.
during 42 days post vaccination
Safety of BARYCELA inj.: Vital signs
Time Frame: Day0(Pre vaccination), 42 days post vaccination
Vital signs
Day0(Pre vaccination), 42 days post vaccination
Safety of BARYCELA inj.: Body temperature
Time Frame: Day0(Pre vaccination), 42 days post vaccination
Body temperature; measured according to standard of care and thermometer instructions.
Day0(Pre vaccination), 42 days post vaccination
Safety of BARYCELA inj.: Complete physical examination
Time Frame: Day0(Pre vaccination), 42 days post vaccination
Complete physical examination; performed at Screening/Enrollment (Day 0) and Final Visit(Day 42).
Day0(Pre vaccination), 42 days post vaccination
Safety of BARYCELA inj.: Symptom-directed physical examination
Time Frame: Day0(Pre vaccination), during 42 days post vaccination
Symptom-directed physical examination (if any symptoms); performed at other timepoints as indicated to assess changes from Screening
Day0(Pre vaccination), during 42 days post vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Immunogenicity of BARYCELA inj.: Geometric Mean Titer (GMT)
Time Frame: Prior to IP administration and 42 days post vaccination
Geometric Mean Titer (GMT) of antibody titer measured with gpELISA
Prior to IP administration and 42 days post vaccination
Immunogenicity of BARYCELA inj.: Geometric Mean Fold Rise (GMFR)
Time Frame: Prior to IP administration and 42 days post vaccination
Geometric Mean Fold Rise (GMFR)
Prior to IP administration and 42 days post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GC Biopharma Corp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MG1111_VAR_P0302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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