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Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactivated Split Influenza Vaccine in Healthy Korea Children

NCT02263131 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2020-07-09

Study results available
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Summary

The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) administered as a single intramuscular injection.

Conditions

  • Healthy

Interventions

BIOLOGICAL

IL-YANG FLU Vaccine Prefilled Syringe INJ.

IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL

BIOLOGICAL

VAXIGRIP Prefilled Syringe INJ.

VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL

Sponsors & Collaborators

  • Il-Yang Pharm. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jin-Han Kang, MD.PhD · Seoul St. Mary's Hospital, The Catholic University of Korea

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-01-31
Completion
2014-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02263131 on ClinicalTrials.gov