Evaluating a second varicella vaccination in young children
A Double-blind, Randomized, Multi-Center, Active Controlled Phase 2 Clinical Trial to 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
PHASE2 · GC Biopharma Corp · NCT05422508
This study is testing a second chickenpox vaccine in healthy kids aged 4 to 6 to see if it's safe and helps boost their immunity after they’ve already had the first shot.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 4 Years to 6 Years |
| Sex | All |
| Sponsor | GC Biopharma Corp (industry) |
| Drugs / interventions | prednisone |
| Locations | 1 site (Ansan) |
| Trial ID | NCT05422508 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy children aged 4 to 6 years with a history of receiving their first varicella vaccination at least three years prior.
Not a fit: Patients who have had multiple varicella vaccinations or recent exposure to varicella may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the immune response in children against varicella, potentially leading to better protection against the disease.
How similar studies have performed: Other studies have shown promising results with similar vaccination approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ansan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Varicella