A Study of MG1111 in Healthy Children

Green Cross Corporation

Status and phase: Completed; Phase 3; Phase 2

Conditions: Healthy Children

Treatments: Drug: Varicella Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03375502

MG1111_P2/3

Details and patient eligibility

About

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

Enrollment: 814 patients

Sex: All

Ages: 12 months to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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814 participants in 2 patient groups

MG1111(Varicella vaccine)

Experimental group

Description:

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

Treatment:

Drug: Varicella Vaccine

Comparator(Varicella vaccine)

Active Comparator group

Description:

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

Treatment:

Drug: Varicella Vaccine