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OpenTrials
Completed

NCT Number: NCT03375502

A Study of MG1111 in Healthy Children

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

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Key information

Conditions

Healthy Children

Age range

12 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Banpo-dong, Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Varicella Vaccine

Drug

The subject will receive investigational product or comparator.

Other names: vaccination

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

Sponsors and collaborators

Lead sponsor

Green Cross Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 18, 2017
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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