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Recruiting Phase 2

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

NCT05422508 · tracked via the Priya Life Science South Korea tracker
Sponsor
Green Cross Corporation
Phase
Phase 2
Started
2022-07-05
Last updated
2024-01-24

Condition(s) studied

Varicella

Investigational drug(s) / intervention(s)

MG1111 (BARICELA)VARIVAX →Suduvax

MG1111 (BARICELA): 0.5ml, single dose, subcutaneous injection

VARIVAX: 0.5ml, single dose, subcutaneous injection

Suduvax: 0.5ml, single dose, subcutaneous injection

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

Sex
ALL
Min age
4 Years
Max age
6 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Incidence of fever (temperature ≥39.0℃) — within 7 days
    Incidence of fever (temperature ≥39.0℃) within 7days after the IP administration
  • Solicited local / systemic adverse events — within 7 days
    Solicited local / systemic adverse events that occurred within 7 days after the IP administration
  • Unsolicited adverse events — within 42 days
    Unsolicited adverse events that occurred within 42 days after the IP administration
  • Vital signs (blood pressure, pulse rate, respiration rate and body temperature) — within 42 days
    descriptive statistics (number of subjects, mean, standard deviation, median, minimum, and maximum) of change from baseline to 42 days will be presented for each group.
  • Incidence of fever (temperature ≥39.0℃) — within 42days
    Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration
  • Physical examinations (Cardiovascular, respiratory, gastrointestinal, liver, metabolic/endocrine, kidney, reproductive, musculoskeletal and nervous system, head/neck, and skin) — within 42 days
    the change from baseline to 42 days will be classified into 'normal/abnormal, not clinically significant (NCS)' or 'abnormal, clinically significant (CS)', and the frequency and percentage are presented in a shift table.

Trial sites (1)

FacilityCityRegionStatus
Korea University Ansan Hospital Ansan South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05422508 on ClinicalTrials.gov ↗ ← All trials in South Korea