Immunogenicity and Safety for 'IL-YANG Quadrivalent Influenza Vaccine' in Healthy Korean Children and Adolescents
NCT03445468 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 379
Last updated 2020-05-11
Summary
The purpose of this study is to evaluate the immunogenicity and safety of 'IL-YANG Quadrivalent Seasonal Influenza Vaccine' in healthy Korean children and adolescents.
Conditions
- Influenza, Human
Interventions
- BIOLOGICAL
-
IL-YANG Quadrivalent Influenza Vaccine
A single 0.5mL dose administrated as an intramuscular injection.
- BIOLOGICAL
-
IL-YANG Flu Vaccine Pre-filled Syringe
A single 0.5mL dose administrated as an intramuscular injection.
Sponsors & Collaborators
-
Il-Yang Pharm. Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jin-Han Kang, MD.PhD · The catholic university of Korea, Seoul ST. Marry's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 3 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-09-20
- Primary Completion
- 2017-12-29
- Completion
- 2018-08-30
Countries
- South Korea
Study Locations
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