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

Varicella Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05422508
• Other study ID #: MG1111_VAR_P0201
• Status: Recruiting
• Phase: Phase 2
• Start date: July 5, 2022
• Est. completion date: June 2027

Study information

• Verified date: January 2024
• Source: GC Biopharma Corp
• Contact: Hye Won Shin
• Phone: +82-31-260-9032
• Email: hwshin27[@]gccorp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

1. Safety

• Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration

• Incidence of fever (temperature ≥39.0℃) within 7 days after the IP administration

• Solicited local/systemic AEs occurred within 7 days after the IP administration

• Unsolicited adverse events that occurred within 42 days after the IP administration

• Serious adverse events that occurred within 1 year after the IP administration

• Vital signs and physical examinations

2. 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

3. Exploratory assessment

• 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 measured by gpELISA at before and after the IP administration for 3 years

• Varicella-like rash and Varicella-zoster virus genotyping analysis occurred after IP administration for 3 years

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: June 2027
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

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

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Varicella

Intervention

Biological:
• MG1111 (BARICELA)
0.5ml, single dose, subcutaneous injection
• VARIVAX
0.5ml, single dose, subcutaneous injection
• Suduvax
0.5ml, single dose, subcutaneous injection

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	GMV and GMR of VZV-CMI response	GMV and GMR of VZV-CMI response measured by INF-r ELISPOT at before and 42 days after the IP administration	at Day1, Day42
Other	GMT and GMR of the antibody titer	GMT and GMR of the antibody titer measured by gpELISA at before and after the IP administration for 3 year	at Year1, Year2, Year3
Other	Varicella-like rash	Varicella-like rash occurred after IP administration for 3 years	anytime within 3 years (if applicable)
Other	Varicella-zoster virus genotyping	Varicella-zoster virus genotyping analysis occurred after IP administration for 3 years	anytime within 3 years (if applicable)
Primary	Incidence of fever (temperature =39.0?)	Incidence of fever (temperature =39.0?) within 7days after the IP administration	within 7 days
Primary	Solicited local / systemic adverse events	Solicited local / systemic adverse events that occurred within 7 days after the IP administration	within 7 days
Primary	Unsolicited adverse events	Unsolicited adverse events that occurred within 42 days after the IP administration	within 42 days
Primary	Vital signs (blood pressure, pulse rate, respiration rate and body temperature)	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.	within 42 days
Primary	Incidence of fever (temperature =39.0?)	Incidence of fever (temperature =39.0?) within 42 days after the IP administration	within 42days
Primary	Physical examinations (Cardiovascular, respiratory, gastrointestinal, liver, metabolic/endocrine, kidney, reproductive, musculoskeletal and nervous system, head/neck, and skin)	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.	within 42 days
Secondary	Serious adverse events	Serious adverse events that occurred within 1 year after the IP administration	within 1 year
Secondary	GMT and GMR of the antibody titer	GMT and GMR of the antibody titer measured by gpELISA at before and 42 days after the IP administration	at Day1, Day42