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

NCT04381689 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2026-03-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG Quadrivalent Seasonal Influenza Vaccine) in healthy infants from 6 months to under 3 years of age(≥ 6 months and \< 3 years)

Conditions

  • Healthy

Interventions

BIOLOGICAL

IL-YANG FLU Vaccine Prefilled Syringe INJ.

Teratect Prefilled Syringe Inj. 0.5mL

BIOLOGICAL

Fluarix Tetra Pre-filled Syringe

Fluarix Tetra Pre-filled Syringe 0.5mL

Sponsors & Collaborators

  • Il-Yang Pharm. Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-10-23
Primary Completion
2025-05-20
Completion
2026-05-31

Countries

  • South Korea

Study Locations

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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 NCT04381689 on ClinicalTrials.gov