Actively Recruiting
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
Led by Green Cross Corporation · Updated on 2024-01-24
230
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy children between 4 and 6 years of age as of the date of written consent
- History of 1st varicella vaccination at least 3 years before study vaccination
- Parent or legal representative willing to provide written informed consent and able to comply with study requirements
- Negative history of varicella infection
You will not qualify if you...
- Exposure to varicella patient at home, school, or childcare within 4 weeks before vaccination
- History of two or more varicella vaccine injections
- Acute fever (at least 38.0°C) within 72 hours before vaccination
- Suspected allergy symptoms including systemic rash within 72 hours before vaccination
- History of Guillain-Barre syndrome
- Severe chronic disease deemed ineligible by Investigator
- Hypersensitivity to ingredients like gelatin, neomycin, kanamycin, erythromycin
- Active tuberculosis
- Other vaccinations within 4 weeks before vaccination
- Immunodeficiency history
- Use of salicylates within 4 weeks before vaccination
- Immune globulin, gamma globulin, or blood products within 44 weeks before vaccination
- Immunosuppressant or immune modifying drugs within 12 weeks before vaccination
- Use of anti-viral drugs within 4 weeks before vaccination
- Participation in other clinical trials within 24 weeks before vaccination
- Other clinically significant medical or psychological conditions deemed ineligible by Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Korea University Ansan Hospital
Ansan, South Korea
Actively Recruiting
Research Team
H
Hye Won Shin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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