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

NCT05422508 | Recruiting Phase 2

• 1 other identifier: MG1111_VAR_P0201
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Varicella

Outcome Measures

Primary Outcomes (6)

• Incidence of fever (temperature ≥39.0℃)

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

  within 7 days

• Solicited local / systemic adverse events

  Solicited local / systemic adverse events that occurred within 7 days after the IP administration

  within 7 days

• Unsolicited adverse events

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

  within 42 days

• 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

• Incidence of fever (temperature ≥39.0℃)

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

  within 42days

• 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 Outcomes (2)

• Serious adverse events

  within 1 year

• GMT and GMR of the antibody titer

  at Day1, Day42

Other Outcomes (4)

• GMV and GMR of VZV-CMI response

  at Day1, Day42

• GMT and GMR of the antibody titer

  at Year1, Year2, Year3

• Varicella-like rash

  anytime within 3 years (if applicable)

Study Arms (3)

MG1111(BARICELA) arm

EXPERIMENTAL

0.5ml, single dose, subcutaneous injection

Biological: MG1111 (BARICELA)

VARIVAX arm

ACTIVE COMPARATOR

0.5ml, single dose, subcutaneous injection

Biological: VARIVAX

Suduvax arm

ACTIVE COMPARATOR

0.5ml, single dose, subcutaneous injection

Biological: Suduvax

Interventions

MG1111 (BARICELA) BIOLOGICAL

0.5ml, single dose, subcutaneous injection

MG1111(BARICELA) arm

VARIVAX BIOLOGICAL

0.5ml, single dose, subcutaneous injection

VARIVAX arm

Suduvax BIOLOGICAL

0.5ml, single dose, subcutaneous injection

Suduvax arm

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Green Cross Corporation: lead

Study Sites (1)

Korea University Ansan Hospital

Ansan, South Korea

RECRUITING

MeSH Terms

Conditions

Chickenpox

Interventions

Chickenpox Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Yun-kyung Kim, M.D., Ph.D

  Korea University Ansan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hye Won Shin

CONTACT

+82-31-260-9032; hwshin27@gccorp.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: After the Protocol v4.1 was approved by Ministry of Food and Drug Safety (02Jun2023), Subject eligibility was change to 4 \~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination instead of 1st SUDUVAX inj. and Active Comparator: VARIVAX arm was deleted. \*VARIVAX release has been discontinued.

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 16, 2022
• Study Start: July 5, 2022
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

KR (1)