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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MG1111 (Barycela inj.), VARIVAX™.
- Who it may be relevant to
- Registry conditions: Varicella (Chickenpox), Chickenpox Vaccine. Basic parameters: 12 months — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Biological MG1111 (Barycela inj.)
MG1111 (Barycela inj.) - Biological VARIVAX™
Varivax™
Primary outcome measures
- Proportion of participants who achieved seroconversion at 42 days after second vaccination [Time frame: 42 days after second vaccination]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- 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
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Thailand · 1 center
- Srinagarind Hospital — Khon Kaen
Identifiers
NCT: NCT07054099 · MG1111_VAR2D_P0304