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Tests treatment safety and results for Varicella
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
ClinicalTrials.gov ID: NCT05422508
What this study is testing
What is MG1111 (BARICELA)?
MG1111 (BARICELA) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for varicella.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 6. Healthy volunteers may be eligible.
You may be able to join if
- Healthy children between 4 and 6 years of age as of the date of written consent
- people who have a history of 1st Varicella vaccination at least 3 years ago from the administration of investigational product
- people or parent/legal representative willing to provide written informed consent and able to comply with the study requirements
- Negative history of Varicella infection
You likely can't join if
- people with a history of exposure to varicella through contact with a varicella patient at home, school, or childcare facility within 4 weeks before...
- people who have a history 2 times or more of varicella vaccine injections
- people who had an acute febrile (at least 38.0 ℃) episode at some time during the 72 hours before the administration of investigational product
- people who had any suspected allergy symptoms including systemic rash during the 72 hours before the administration of investigational product
- people with a history of Guillain-Barre syndrome.
- people with a severe chronic disease and considered ineligible for the study at Investigator's discretion
See the full eligibility criteria
- Healthy children between 4 and 6 years of age as of the date of written consent
- people who have a history of 1st Varicella vaccination at least 3 years ago from the administration of investigational product
- people or parent/legal representative willing to provide written informed consent and able to comply with the study requirements
- Negative history of Varicella infection
- people 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
- people who have a history 2 times or more of varicella vaccine injections
- people who had an acute febrile (at least 38.0 ℃) episode at some time during the 72 hours before the administration of investigational product
- people who had any suspected allergy symptoms including systemic rash during the 72 hours before the administration of investigational product
- people with a history of Guillain-Barre syndrome.
- people with a severe chronic disease and considered ineligible for the study at Investigator's discretion
- people with a history of hypersensitivity to any ingredient such as gelatin, antibiotics (Neomycin, Kanamycin, Erythromycin)
- Active tuberculosis patient
- people who had received other vaccinations within 4 weeks before the administration of investigational product
- people with immunodeficiency history
- people who had received salicylates (aspirin, bismuth, subsalicylates) within 4 weeks before the administration of investigational drug
- people who administered immune globulin, gamma globulin, or blood products such as whole blood within 44 weeks before the administration of investigational drug
- people 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. people who administered high dose of corticosteroids (greater than 2 mg/kg/day in case of under 10kg people or ≥20mg/day in case of above 10kg subject of prednisone for 14 days) (However, inhaled, intranasal, topical...
- people who administered anti-viral drug within 4 weeks before the administration of investigational drug
- people who have participated in any other clinical trials within 24 weeks of the administration of the investigational product
- people with other clinically significant medical or psychological condition who are considered by the Investigator to be ineligible for the study
The study team makes the final eligibility decision.
Where it's taking place
- Ansan, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 6 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ansan, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.