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

Launched by GREEN CROSS CORPORATION · Jun 14, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a second dose of the MG1111 vaccine for children aged 4 to 6 years who have already received their first varicella (chickenpox) vaccination at least three years ago. The main goal is to find out if this second vaccination is safe to give, and to see how well it helps the immune system recognize and fight the varicella virus.

To be eligible for the trial, children must be healthy, aged between 4 and 6, and must not have had chickenpox before. They should also not have received any other vaccinations in the month before the study starts. Parents or guardians must be willing to give written consent for their child to participate. If chosen, participants can expect to be monitored for safety and how their immune system responds to the vaccine for about 42 days after receiving it. This study is important for understanding how to better protect children against chickenpox.

Gender

ALL

Eligibility criteria

• 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