Recruiting
Phase 2
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
Condition(s) studied
Varicella
Investigational drug(s) / intervention(s)
MG1111 (BARICELA): 0.5ml, single dose, subcutaneous injection
VARIVAX: 0.5ml, single dose, subcutaneous injection
Suduvax: 0.5ml, single dose, subcutaneous injection
Study summary
* 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
Eligibility
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
Primary outcome measure(s)
- Incidence of fever (temperature ≥39.0℃) — within 7 days
Incidence of fever (temperature ≥39.0℃) within 7days after the IP administration
- Solicited local / systemic adverse events — within 7 days
Solicited local / systemic adverse events that occurred within 7 days after the IP administration
- Unsolicited adverse events — within 42 days
Unsolicited adverse events that occurred within 42 days after the IP administration
- Vital signs (blood pressure, pulse rate, respiration rate and body temperature) — within 42 days
descriptive statistics (number of subjects, mean, standard deviation, median, minimum, and maximum) of change from baseline to 42 days will be presented for each group.
- Incidence of fever (temperature ≥39.0℃) — within 42days
Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration
- Physical examinations (Cardiovascular, respiratory, gastrointestinal, liver, metabolic/endocrine, kidney, reproductive, musculoskeletal and nervous system, head/neck, and skin) — within 42 days
the change from baseline to 42 days will be classified into 'normal/abnormal, not clinically significant (NCS)' or 'abnormal, clinically significant (CS)', and the frequency and percentage are presented in a shift table.
Trial sites (1)
| Facility | City | Region | Status |
| Korea University Ansan Hospital |
Ansan |
South Korea |
Recruiting |