Actively Recruiting
Double-blind, Randomized, Multi-Center Trial Evaluating Safety and Immune Response of MG1111 (BARICELA Inj.) as Second Varicella Vaccination in Healthy Children Aged 4 to 6 Years with Prior Varicella Vaccination
Led by Green Cross Corporation · Updated on 2024-01-24
230
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and immune response of MG1111 (BARICELA Inj.) when used as a second varicella vaccination in healthy children aged 4 to 6 years who have previously received a first varicella vaccination. This Phase 2 clinical trial aims primarily to assess safety up to 42 days after vaccination and secondarily to evaluate immune responses and ongoing safety. The study is designed as a double-blind, randomized, multi-center trial comparing MG1111 with two other varicella vaccines, VARIVAX and Suduvax. Participants receive a single 0.5ml dose of their assigned vaccine by subcutaneous injection as the second varicella vaccination. The trial includes three groups: MG1111, VARIVAX, and Suduvax arms, each receiving the same dose and method of administration. The study monitors participants closely for safety and immune response over multiple time points, including an initial 42-day period and extended monitoring for up to three years for immune markers and varicella-related events. During the study, children will be monitored for fever, local and systemic side effects, physical exams, and vital signs within 42 days post-vaccination. Serious adverse events are tracked for up to one year. Blood samples will be taken to assess antibody levels and cellular immune responses before vaccination and at 42 days post-vaccination, with additional antibody testing up to three years. Researchers also evaluate any varicella-like rash and virus genetics during the extended follow-up. Participation involves regular visits for assessments and safety monitoring throughout the study duration.
CONDITIONS
Brief 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 aged 4 to 6 years at the time of consent
- History of exactly one varicella vaccination at least 3 years prior to study vaccination
- Negative history of varicella infection
- Parent or legal representative willing to provide written informed consent and comply with study requirements
You will not qualify if you...
- Contact with a 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 gelatin or antibiotics such as Neomycin, Kanamycin, Erythromycin
- Active tuberculosis
- Vaccination with other vaccines within 4 weeks before study vaccination
- Immunodeficiency history
- Use of salicylates (aspirin, bismuth, subsalicylates) within 4 weeks before vaccination
- Receipt of immune globulin, gamma globulin, or blood products within 44 weeks before vaccination
- Use of immunosuppressant or immune-modifying drugs within 12 weeks before vaccination
- History of anti-viral drug use within 4 weeks before vaccination
- Participation in other clinical trials within 24 weeks before study vaccination
- Any other significant medical or psychological condition making participation unsuitable
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single subcutaneous injection of one of the study vaccines as their second varicella vaccination.
1 vaccination visit (in-person)
Duration - 42 days
Participants are monitored for safety including fever, adverse events, vital signs, and physical examinations and their immune response is assessed.
Multiple visits within 42 days including assessments within 7 days and follow-up visits up to day 42
Duration - 3 years
Participants are followed for up to 3 years to monitor antibody levels and any varicella-like rash or related events.
Periodic visits for immunogenicity assessments and safety monitoring
Trial Site Locations
Total: 1 location
1
Korea University Ansan Hospital
Ansan, South Korea
Actively Recruiting
Research Team
H
Hye Won Shin
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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