Evaluating a second varicella vaccination in young children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and immunogenicity of the MG1111 (BARICELA) vaccine when administered as a second vaccination to healthy children aged 4 to 6 years who have previously received a first varicella vaccination. The study will monitor adverse events and fever incidence for 42 days post-vaccination, as well as measure immune response through various assays at baseline and after vaccination. The trial will also explore the long-term effects of the vaccine over a three-year period.

Why it matters

Who can join: the full rules

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

Where it's running

• Korea University Ansan Hospital
  Ansan, South Korea Recruiting

Study contacts

• Principal investigator: Yun-kyung Kim, M.D., Ph.D — Korea University Ansan Hospital
• Study coordinator: Hye Won Shin
• Email: hwshin27@gccorp.com
• Phone: +82-31-260-9032

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.