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

Recruiting now · Phase 2

Conditions studied: Varicella

In brief

* 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

Key facts

Study ID

NCT05422508

Run by

Green Cross Corporation

People needed

230

Starts

2022-07-05

Expected to finish

2027-06-01

Last updated by the study team

2024-01-24

Who can join

Age: 4 and older, up to 6. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Korea University Ansan Hospital — Ansan, South Korea (enrolling)

Full record on ClinicalTrials.gov

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