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

ConditionVaricella
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age4-6
SponsorGreen Cross Corporation

About this trial

* 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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • MG1111 (BARICELA)
  • VARIVAX
  • Suduvax

Treatment groups

230 Participants
are divided into 3 treatment groups

Sponsors and collaborators