Evaluate the Safety and Immunogenicity After MG1111(BARICELA Inj.) as 2nd Vaccination in 4 ~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination

Last updated: January 23, 2024
Sponsor: Green Cross Corporation
Overall Status: Active - Recruiting

Phase

2

Condition

Herpes Simplex Infections

Rash

Shingles

Treatment

MG1111 (BARICELA)

VARIVAX

Suduvax

Clinical Study ID

NCT05422508
MG1111_VAR_P0201
  • Ages 4-6
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

  • Primary objective is to assess the safety of MG1111 until Day 42 using as 2nd vaccination

  • Secondary objective to assess the immunogenicity and safety of MG1111 using as 2nd vaccination

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy children between 4 and 6 years of age as of the date of written consent
  • Subjects who have a history of 1st Varicella vaccination at least 3 years ago from theadministration of investigational product
  • Subjects or parent/legal representative willing to provide written informed consentand able to comply with the study requirements
  • Negative history of Varicella infection

Exclusion

Exclusion Criteria:

  • Subjects with a history of exposure to varicella through contact with a varicellapatient at home, school, or childcare facility within 4 weeks before theadministration of investigational drug
  • Subjects who have a history 2 times or more of varicella vaccine injections
  • Subjects who had an acute febrile (at least 38.0 ℃) episode at some time during the 72hours before the administration of investigational product
  • Subjects who had any suspected allergy symptoms including systemic rash during the 72hours before the administration of investigational product
  • Subjects with a history of Guillain-Barre syndrome.
  • Subjects with a severe chronic disease and considered ineligible for the study atInvestigator's discretion
  • Subjects with a history of hypersensitivity to any ingredient such as gelatin,antibiotics (Neomycin, Kanamycin, Erythromycin)
  • Active tuberculosis patient
  • Subjects who had received other vaccinations within 4 weeks before the administrationof investigational product
  • Subjects with immunodeficiency history
  • Subjects who had received salicylates (aspirin, bismuth, subsalicylates) within 4weeks before the administration of investigational drug
  • Subjects who administered immune globulin, gamma globulin, or blood products such aswhole blood within 44 weeks before the administration of investigational drug
  • Subjects who had received immunosuppressant or immune modifying drug within 12 weeksbefore the administration of investigational drug
  • A. Azathioprine, Cyclosporin, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus,etc.
  • B. Subjects who administered high dose of corticosteroids (greater than 2 mg/kg/day incase of under 10kg subjects or ≥20mg/day in case of above 10kg subject of prednisonefor 14 days) (However, inhaled, intranasal, topical corticosteroids administration inallowed)
  • Subjects who administered anti-viral drug within 4 weeks before the administration ofinvestigational drug
  • Subjects who have participated in any other clinical trials within 24 weeks of theadministration of the investigational product
  • Subjects with other clinically significant medical or psychological condition who areconsidered by the Investigator to be ineligible for the study

Study Design

Total Participants: 230
Treatment Group(s): 3
Primary Treatment: MG1111 (BARICELA)
Phase: 2
Study Start date:
July 05, 2022
Estimated Completion Date:
June 30, 2027

Study Description

  1. Safety

    -  Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration

-  Incidence of fever (temperature ≥39.0℃) within 7 days after the IP administration

-  Solicited local/systemic AEs occurred within 7 days after the IP administration

-  Unsolicited adverse events that occurred within 42 days after the IP administration

-  Serious adverse events that occurred within 1 year after the IP administration

-  Vital signs and physical examinations

  2. Efficacy (Immunogenicity)

    -GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio(fold change))measured by the glycoprotein enzyme-linked immunosorbent assay (gpELISA) at before and 42 days after the IP administration

  3. Exploratory assessment

    • GMV and GMR of VZV-CMI response measured by INF-r ELISPOT at before and 42 days after the IP administration

    • GMT and GMR of the antibody titer measured by gpELISA at before and after the IP administration for 3 years

    • Varicella-like rash and Varicella-zoster virus genotyping analysis occurred after IP administration for 3 years

Connect with a study center

  • Korea University Ansan Hospital

    Ansan,
    Korea, Republic of

    Active - Recruiting

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