Varicella (Chickenpox)Phase 3NCT07054099
A Study to Evaluate Immunogenicity and Safety After the First and Second Doses of MG1111 (BARYCELA Inj.) in Healthy Children Aged 12 Months to 12 Years
A Phase 3 study testing MG1111 (Barycela inj.) and VARIVAX™ in people with Varicella (Chickenpox) and Chickenpox Vaccine, run by GC Biopharma Corp at 1 site in Thailand.
Trial summary
This clinical study aims to evaluate the safety and immune response of MG1111, in healthy children compared to VARIVAX. The study will follow participants for 42 days after receiving two doses, with additional follow-ups for up to 10 years to monitor varicella infection. Read more about this study
- Who is it for?
- Ages 12 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicella (Chickenpox), Chickenpox Vaccine
- What is being tested?
- MG1111 (Barycela inj.) and VARIVAX™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 1 siteThailand
- Study dates
- 17 Mar 2026to Jul 2036
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participant must be 12 months to 12 years of age, inclusive, at the time of signing the informed consent or assent.
- Participant is overtly healthy as determined by the investigator
Who cannot join
- Participants with a history of exposure to varicella through contact with a varicella patient at home, school, or childcare facility within 4 weeks before Screening
- Participants with a history of varicella infection and varicella vaccine, either licensed or investigational, and either standalone or any combination, such as MMRV
- Participants with acute moderate or severe infection with or without fever at the time of dosing
- Participants who have had any suspected allergy symptoms, such as systemic rash, during the 72 hours before each administration of investigational product
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sujin Lee contact
Thailand1 site, 1 recruiting
- Recruiting
Srinagarind Hospital
Khon Kaen, Changwat Khon Kaen, 40002
About this study
Official title: A Phase III, Double-blind, Randomized, Multicenter, Multinational, Active-controlled, Non-inferiority Study to Evaluate Immunogenicity and Safety After the First and Second Doses of MG1111 (BARYCELA Inj.) in Healthy Children Aged 12 Months to 12 Years
This clinical study aims to evaluate the safety and immune response of MG1111, in healthy children compared to VARIVAX. The study will follow participants for 42 days after receiving two doses, with additional follow-ups for up to 10 years to monitor varicella infection.
- Conditions
- Varicella (Chickenpox), Chickenpox Vaccine
- Being tested
- MG1111 (Barycela inj.), VARIVAX™
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MG1111 (Barycela inj.)Biological
MG1111 (Barycela inj.)
VARIVAX™Biological
Varivax™
| Study group | Role | What they receive |
|---|---|---|
| MG1111 (Barycela inj.) | Experimental | Not described Receives: Biological: MG1111 (Barycela inj.) |
| Varivax™ | Active comparator | Not described Receives: Biological: VARIVAX™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who achieved seroconversion at 42 days after second vaccination
Measured: 42 days after second vaccination
Secondary outcomes (3)
Percentage of participants reporting local and systemic solicited adverse events during the first 7 days after each vaccination with MG1111 or VARIVAX
Measured: 7 days after each vaccination
Percentage of participants reporting unsolicited adverse events during the first 42 days after each vaccination with MG1111 or VARIVAX
Measured: 42 days after each vaccination
Percentage of participants reporting serious adverse events until 6 months after second vaccination with MG1111 or VARIVAX
Measured: 6 months after second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start17 Mar 2026
- Primary completionAug 2027 (estimated)
- Study completionJul 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicella (Chickenpox)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 474 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GC Biopharma Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054099
- Sponsor's protocol ID
- MG1111_VAR2D_P0304
- Status last verified
- Apr 2026
- First submitted
- 7 Jul 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Double-blind, Randomized, Multicenter, Multinational, Active-controlled, Non-inferiority Study to Evaluate Immunogenicity and Safety After the First and Second Doses of MG1111 (BARYCELA Inj.) in Healthy Children Aged 12 Months to 12 Years
- ClinicalTrials.gov ID
- NCT07054099
- Acronym / sponsor ID
- MG1111_VAR2D_P0304
- Conditions
- Varicella (Chickenpox), Chickenpox Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 474 participants (estimated)
- Lead sponsor
- GC Biopharma CorpIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Jul 2036 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study aims to evaluate the safety and immune response of MG1111, in healthy children compared to VARIVAX. The study will follow participants for 42 days after receiving two doses, with additional follow-ups for up to 10 years to monitor varicella infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MG1111 (Barycela inj.) | Experimental | Biological: MG1111 (Barycela inj.) |
| Varivax™ | Active comparator | Biological: VARIVAX™ |
Who may qualify
- Ages
- 12 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Participant must be 12 months to 12 years of age, inclusive, at the time of signing the informed consent or assent.
- Participant is overtly healthy as determined by the investigator
Key exclusion criteria (4 listed)
- Participants with a history of exposure to varicella through contact with a varicella patient at home, school, or childcare facility within 4 weeks before Screening
- Participants with a history of varicella infection and varicella vaccine, either licensed or investigational, and either standalone or any combination, such as MMRV
- Participants with acute moderate or severe infection with or without fever at the time of dosing
- Participants who have had any suspected allergy symptoms, such as systemic rash, during the 72 hours before each administration of investigational product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MG1111 (Barycela inj.)MG1111 (Barycela inj.) | Biological | MG1111 (Barycela inj.) |
| VARIVAX™Varivax™ | Biological | Varivax™ |
Primary outcome
Proportion of participants who achieved seroconversion at 42 days after second vaccination
Time frame: 42 days after second vaccination
3 secondary outcomes
Percentage of participants reporting local and systemic solicited adverse events during the first 7 days after each vaccination with MG1111 or VARIVAX
Time frame: 7 days after each vaccination
Percentage of participants reporting unsolicited adverse events during the first 42 days after each vaccination with MG1111 or VARIVAX
Time frame: 42 days after each vaccination
Percentage of participants reporting serious adverse events until 6 months after second vaccination with MG1111 or VARIVAX
Time frame: 6 months after second vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sujin Lee contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MG1111 (Barycela inj.) and VARIVAX™ in people with Varicella (Chickenpox) and Chickenpox Vaccine, run by GC Biopharma Corp at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minji Ko (+82-31-260-9143, mg1111d@gccorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who achieved seroconversion at 42 days after second vaccination (time frame: 42 days after second vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.