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RecruitingNCT07054099Updated Apr 17, 2026

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 interventional study of MG1111 (Barycela inj.) and VARIVAX™ in Varicella (Chickenpox) and Chickenpox Vaccine, sponsored by GC Biopharma Corp. Recruiting at 1 site in Thailand. Open to participants aged 12 Months to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by GC Biopharma Corp · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
474
Allocation
Randomized
Ages
12 Months to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Varicella (Chickenpox)
  • Chickenpox Vaccine

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03

In context

Chickenpox

180 studies on the registry are indexed under Chickenpox; 28 are open to participants now.

This study's planned enrollment of 474 is close to the median of 475 across 149 interventional studies indexed under Chickenpox.

Browse Chickenpox studies →

Lead sponsor

GC Biopharma Corp is the lead sponsor of 15 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant must be 12 months to 12 years of age, inclusive, at the time of signing the or assent.
  • Participant is overtly healthy as determined by the investigator

Exclusion criteria

Exclusion Criteria:

  • 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 , 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
474 participants (estimated)

Study arms

  • Experimental
    MG1111 (Barycela inj.)

    Biological: MG1111 (Barycela inj.)

  • Active comparator
    Varivax™

    Biological: VARIVAX™

Interventions

06

What researchers measure

Primary outcomes

  1. Proportion of participants who achieved seroconversion at 42 days after second vaccination

    Time frame: 42 days after second vaccination

Secondary outcomes

  1. 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

  2. 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

  3. Percentage of participants reporting serious adverse events until 6 months after second vaccination with MG1111 or VARIVAX

    Time frame: 6 months after second vaccination

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Aug 2027, 17 months after the start.

Of 35 industry-sponsored phase 3 interventional studies under Chickenpox, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 15. This study's planned 17 months is above that.

Counting every sponsor, half of 39 studies reached it within 13 months; a quarter within 9 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 7, 2025
First posted
Jul 8, 2025
StartActual
Mar 17, 2026
Primary completionEst.
Aug 2027
CompletionEst.
Jul 2036
Last update
Apr 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07054099
Lead sponsor
GC Biopharma Corp
Responsible party
Sponsor
First posted
Jul 8, 2025
Start date
Mar 17, 2026
Primary completion
Aug 2027 (estimated)
Completion
Jul 2036 (estimated)
Last update
Apr 17, 2026

Study contacts

Minji Ko
Contact
mg1111d@gccorp.com
+82-31-260-9143
Sujin Lee
Contact
mg1111d@gccorp.com

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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