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CompletedNCT03375502Updated May 14, 2021

A Study of MG1111 in Healthy Children

A Phase 2/3 interventional study of Varicella Vaccine in Healthy Children, sponsored by Green Cross Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 12 Months to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-14.

Sponsored by Green Cross Corporation · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
814
Allocation
Randomized
Ages
12 Months to 12 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Children
03

Who can participate

Ages eligible
12 Months to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
814 participants (actual)

Study arms

  • Experimental
    MG1111(Varicella vaccine)

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

    Drug: Varicella Vaccine

  • Active comparator
    Comparator(Varicella vaccine)

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

    Drug: Varicella Vaccine

Interventions

  • DrugVaricella Vaccine

    The subject will receive investigational product or comparator.

    Also known as: vaccination

05

What researchers measure

Primary outcomes

  1. Proportion of subjects who achieved seroconversion

    Time frame: 42 days after vaccination

Secondary outcomes

  1. Geometric mean titer(GMT) measured by the FAMA assay

    Time frame: At day 0 and Day 42 post-vaccination

  2. Geometric mean titer(GMT) measured by gpELISA

    Time frame: At day 0 and Day 42 post-vaccination

Other outcomes

  1. Incidence of Local/systemic solicited AEs [Safety]

    Time frame: during the first 7 days after administration of IP

  2. Incidence of Unsolicited AEs [Safety]

    Time frame: Until Day 42 after administration of IP

  3. Incidence of Serious adverse events [Safety]

    Time frame: Until 6 months after administration of IP

06

Study locations

1 site
  • The catholic university of Korea, Seoul st. mary's hospital
    Banpo-dong, Seoul, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03375502
Lead sponsor
Green Cross Corporation
Responsible party
Sponsor
First posted
Dec 18, 2017
Start date
Nov 26, 2016
Primary completion
Jan 29, 2019
Completion
Jul 31, 2019
Last update
May 14, 2021
View the source record on ClinicalTrials.gov ↗

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