A Study of MG1111 in Healthy Children

NCT03375502 | Completed Phase 2

• 1 other identifier: MG1111_P2/3
• Study Type: interventional
• Target: 814
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the safety of MG1111 and to evaluate immunological non-inferiority of MG1111 versus comparator

Conditions

Healthy Children

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who achieved seroconversion

  42 days after vaccination

Secondary Outcomes (2)

• Geometric mean titer(GMT) measured by the FAMA assay

  At day 0 and Day 42 post-vaccination

• Geometric mean titer(GMT) measured by gpELISA

  At day 0 and Day 42 post-vaccination

Other Outcomes (3)

• Incidence of Local/systemic solicited AEs [Safety]

  during the first 7 days after administration of IP

• Incidence of Unsolicited AEs [Safety]

  Until Day 42 after administration of IP

• Incidence of Serious adverse events [Safety]

  Until 6 months after administration of IP

Study Arms (2)

MG1111(Varicella vaccine)

EXPERIMENTAL

A single injection of 0.5ml MG1111 will be administered subcutaneously at Visit 1

Drug: Varicella Vaccine

Comparator(Varicella vaccine)

ACTIVE COMPARATOR

A single injection of 0.5ml comparator will be administered subcutaneously at Visit 1

Drug: Varicella Vaccine

Interventions

Varicella Vaccine DRUG

The subject will receive investigational product or comparator.

Also known as: vaccination

Comparator(Varicella vaccine); MG1111(Varicella vaccine)

Eligibility Criteria

• Age: 12 Months - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children aged 12 months to 12 years.
• Subjects or parent/legal representative willing to provide written informed consent and able to comply with the requirements for the study - Subject able to attend all scheduled visits and to comply with all study procedures
• Negative history of Varicella and varicella vaccine
• Subject in good health, based on medical history and physical examination

You may not qualify if:

• Subjects who have a history of Varicella or administration of varicella vaccine
• Subjects who have ahd an acute febrile episode at some time during the 72 hours before administration of investigational product or those who had any symptom suspected to be allergy including systemic rash.

Sponsors & Collaborators

• Green Cross Corporation: lead

Study Sites (1)

The catholic university of Korea, Seoul st. mary's hospital

Banpo-dong, Seoul, South Korea

Location

MeSH Terms

Interventions

Chickenpox Vaccine; Vaccination

Intervention Hierarchy (Ancestors)

Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Design

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

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 18, 2017
• Study Start: November 26, 2016
• Primary Completion: January 29, 2019
• Study Completion: July 31, 2019
• Last Updated: May 14, 2021

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)