A Study of MG1111 in Healthy Children

Healthy Children Clinical Trial

Official title:

A Phase II/III, Single-blind(Stage 1), Double-blinded(Stage 2), Randomized, Active-controlled, Dose-escalation(Stage 1), Non-inferiority(Stage 2) Study to Evaluate Immunogenicity and Safety of MG1111 in Healthy Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03375502
• Other study ID #: MG1111_P2/3
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 26, 2016
• Est. completion date: July 31, 2019

Study information

• Verified date: December 2017
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 814
• Est. completion date: July 31, 2019
• Est. primary completion date: January 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 12 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Healthy Children

Intervention

Drug:
• Varicella Vaccine
The subject will receive investigational product or comparator.

Locations

Country	Name	City	State
Korea, Republic of	The catholic university of Korea, Seoul st. mary's hospital	Banpo-dong	Seoul

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	Incidence of Local/systemic solicited AEs [Safety]		during the first 7 days after administration of IP
Other	Incidence of Unsolicited AEs [Safety]		Until Day 42 after administration of IP
Other	Incidence of Serious adverse events [Safety]		Until 6 months after administration of IP
Primary	Proportion of subjects who achieved seroconversion		42 days after vaccination
Secondary	Geometric mean titer(GMT) measured by the FAMA assay		At day 0 and Day 42 post-vaccination
Secondary	Geometric mean titer(GMT) measured by gpELISA		At day 0 and Day 42 post-vaccination