Evaluate the Safety and Immunogenicity After MG1111 as 2nd Vaccination in 4 ~ 6 Year Old Healthy Children With a History of 1st SUDUVAX Inj. Vaccination
Study Details
Study Description
Brief Summary
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Primary objective is to assess the safety of MG1111 until Day 42 using as 2nd vaccination
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Secondary objective to assess the immunogenicity and safety of MG1111 using as 2nd vaccination
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
- Safety
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Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration
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Incidence of fever (temperature ≥39.0℃) within 7 days after the IP administration
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Solicited local/systemic AEs occurred within 7 days after the IP administration Unsolicited adverse events that occurred within 42 days after the IP administration
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Serious adverse events that occurred within 1 year after the IP administration
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Vital signs and physical examinations
- Efficacy (Immunogenicity)
-GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio(fold change))measured by the glycoprotein enzyme-linked immunosorbent assay (gpELISA) at before and 42 days after the IP administration
- Exploratory assessment
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GMV and GMR of VZV-CMI response measured by INF-r ELISPOT before and 42 days after the IP administration GMV and GMR of VZV-CMI response measured by INF-r ELISPOT at before and 42 days after the IP administration
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GMT and GMR antibody titer measured by gpELISA assay before and after the IP administration for 3 years GMT and GMR of the antibody titer measured by gpELISA at before and after the IP administration for 3 years
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Varicella-like rash and Varicella-zoster virus genotyping analysis occurred after IP administration for 3 years
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MG1111(BARICELA) arm 0.5ml, single dose, subcutaneous injection |
Biological: MG1111 (BARICELA)
0.5ml, single dose, subcutaneous injection
|
| Active Comparator: VARIVAX arm 0.5ml, single dose, subcutaneous injection |
Biological: VARIVAX
0.5ml, single dose, subcutaneous injection
|
| Active Comparator: Suduvax arm 0.5ml, single dose, subcutaneous injection |
Biological: Suduvax
0.5ml, single dose, subcutaneous injection
|
Outcome Measures
Primary Outcome Measures
- 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.
Secondary Outcome Measures
- Serious adverse events [within 1 year]
Serious adverse events that occurred within 1 year after the IP administration
- GMT and GMR of the antibody titer [at Day1, Day42]
GMT and GMR of the antibody titer measured by gpELISA at before and 42 days after the IP administration
Other Outcome Measures
- GMV and GMR of VZV-CMI response [at Day1, Day42]
GMV and GMR of VZV-CMI response measured by INF-r ELISPOT at before and 42 days after the IP administration
- GMT and GMR of the antibody titer [at Year1, Year2, Year3]
GMT and GMR of the antibody titer measured by gpELISA at before and after the IP administration for 3 year
- Varicella-like rash [anytime within 3 years (if applicable)]
Varicella-like rash occurred after IP administration for 3 years
- Varicella-zoster virus genotyping [anytime within 3 years (if applicable)]
Varicella-zoster virus genotyping analysis occurred after IP administration for 3 years
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy children between 4 and 6 years of age as of the date of written consent
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Subjects who have a history of 1st SUDUVAX inj. at least 3 years ago from the administration of investigational product
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Subjects or parent/legal representative willing to provide written informed consent and able to comply with the study requirements
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Negative history of Varicella infection
Exclusion Criteria:
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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
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Subjects who have a history 2 times or more of varicella vaccine injections
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Subjects who had an acute febrile (at least 38.0 ℃) episode at some time during the 72 hours before the administration of investigational product
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Subjects who had any suspected allergy symptoms including systemic rash during the 72 hours before the administration of investigational product
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Subjects with a history of Guillain-Barre syndrome.
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Subjects with a severe chronic disease and considered ineligible for the study at Investigator's discretion
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Subjects with a history of hypersensitivity to any ingredient such as gelatin, antibiotics (Neomycin, Kanamycin, Erythromycin)
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Active tuberculosis patient
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Subjects who had received other vaccinations within 4 weeks before the administration of investigational product
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Subjects with immunodeficiency history
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Subjects who had received salicylates (aspirin, bismuth, subsalicylates) within 4 weeks before the administration of investigational drug
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Subjects who administered immune globulin, gamma globulin, or blood products such as whole blood within 44 weeks before the administration of investigational drug
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Subjects who had received immunosuppressant or immune modifying drug within 12 weeks before the administration of investigational drug
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- Azathioprine, Cyclosporin, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus, etc.
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- 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)
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Subjects who administered anti-viral drug within 4 weeks before the administration of investigational drug
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Subjects who have participated in any other clinical trials within 24 weeks of the administration of the investigational product
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Subjects with other clinically significant medical or psychological condition who are considered by the Investigator to be ineligible for the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Korea University Ansan Hospital | Ansan | Korea, Republic of |
Sponsors and Collaborators
- Green Cross Corporation
Investigators
- Principal Investigator: Yun-kyung Kim, M.D., Ph.D, Korea University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MG1111_VAR_P0201