A Double-blind, Randomized, Multi-Center, Active Controlled Phase 2 Clinical Trial to Evaluate the Safety and Immunogenicity After MG1111(BARICELA Inj.) as 2nd Vaccination in 4 ~ 6 Year Old Healthy Children With a History of 1st SUDUVAX Inj. Vaccination

  • STATUS
    Recruiting
  • End date
    Jun 24, 2027
  • participants needed
    501
  • sponsor
    Green Cross Corporation
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Updated on 24 October 2022
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Accepts healthy volunteers

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

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 before and 42 days after the IP administration GMV and GMR of VZV-CMI response measured by INF-r ELISPOT at before and 42 days after the IP administration
  • GMT and GMR antibody titer measured by gpELISA assay before and after the IP administration for 3 years 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

Details
Condition Varicella
Treatment Varivax, MG1111 (BARICELA), Suduvax
Clinical Study IdentifierNCT05422508
SponsorGreen Cross Corporation
Last Modified on24 October 2022

Eligibility

 Yes No Not Sure

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 SUDUVAX inj. at least 3 years ago from the administration of investigational product
Subjects or parent/legal representative willing to provide written informed consent and able to comply with the study requirements
Negative history of Varicella infection

Exclusion Criteria

Subjects with a history of exposure to varicella through contact with a varicella patient at home, school, or childcare facility within 4 weeks before the administration 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 72 hours before the administration of investigational product
Subjects who had any suspected allergy symptoms including systemic rash during the 72 hours 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 at Investigator'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 administration of investigational product
Subjects with immunodeficiency history
Subjects who had received salicylates (aspirin, bismuth, subsalicylates) within 4 weeks before the administration of investigational drug
Subjects who administered immune globulin, gamma globulin, or blood products such as whole blood within 44 weeks before the administration of investigational drug
Subjects who had received immunosuppressant or immune modifying drug within 12 weeks before 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 in case of under 10kg subjects or ≥20mg/day in case of above 10kg subject of prednisone for 14 days) (However, inhaled, intranasal, topical corticosteroids administration in allowed)
Subjects who administered anti-viral drug within 4 weeks before the administration of investigational drug
Subjects who have participated in any other clinical trials within 24 weeks of the administration of the investigational product
Subjects with other clinically significant medical or psychological condition who are considered by the Investigator to be ineligible for the study
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