A Study of MG1111 in Healthy Children

NCT ID: NCT03375502

Last Updated: 2021-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

814 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-26

Study Completion Date

2019-07-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MG1111(Varicella vaccine)

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

Group Type EXPERIMENTAL

Varicella Vaccine

Intervention Type DRUG

The subject will receive investigational product or comparator.

Comparator(Varicella vaccine)

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

Group Type ACTIVE_COMPARATOR

Varicella Vaccine

Intervention Type DRUG

The subject will receive investigational product or comparator.

Interventions

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Varicella Vaccine

The subject will receive investigational product or comparator.

Intervention Type DRUG

Other Intervention Names

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vaccination

Eligibility Criteria

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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.
Minimum Eligible Age

12 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Green Cross Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Banpo-dong, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MG1111_P2/3

Identifier Type: -

Identifier Source: org_study_id

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