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

G

Green Cross Corporation

Status and phase

Enrolling
Phase 2

Conditions

Varicella

Treatments

Biological: VARIVAX
Biological: MG1111 (BARICELA)
Biological: Suduvax

Study type

Interventional

Funder types

Industry

Identifiers

NCT05422508
MG1111_VAR_P0201

Details and patient eligibility

About

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

Full description

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 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 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

Enrollment

230 estimated patients

Sex

All

Ages

4 to 6 years old

Volunteers

Accepts Healthy Volunteers

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 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

230 participants in 3 patient groups

MG1111(BARICELA) arm
Experimental group
Description:
0.5ml, single dose, subcutaneous injection
Treatment:
Biological: MG1111 (BARICELA)
VARIVAX arm
Active Comparator group
Description:
0.5ml, single dose, subcutaneous injection
Treatment:
Biological: VARIVAX
Suduvax arm
Active Comparator group
Description:
0.5ml, single dose, subcutaneous injection
Treatment:
Biological: Suduvax

Trial contacts and locations

1

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Central trial contact

Hye Won Shin

Data sourced from clinicaltrials.gov

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