Status:
COMPLETED
Immunogenicity and Safety for 'IL-YANG Quadrivalent Influenza Vaccine' in Healthy Korean Children and Adolescents
Lead Sponsor:
Il-Yang Pharm. Co., Ltd.
Conditions:
Influenza, Human
Eligibility:
All Genders
3-18 years
Phase:
PHASE3
Brief 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.
Detailed Description
The study is an open-label(Part 1), Single-arm(Part 1), Randomized(Part 2), Double-blind(Part 2), Active comparator(Part 2) Phase III study. Before initiation of any protocol-specific activities, wri...
Eligibility Criteria
Inclusion
- Healthy men or women aged from 3 years to \< 19 years
- Subjects were born after full term pregnancy (37 weeks)
- Woman of childbearing potential must have a negative result from Urine Human Chorionic Gonadotropin(HCG) test at the screening visit.
- Voluntary written informed consent was obtained from the subject and the subject's legally acceptable representative (consent of legally acceptable representative was required for subjects younger than 7 years of age)
Exclusion
- Subject with a known serious allergy reaction after influenza vaccination or to any component vaccine including eggs
- Subject who had received an influenza vaccine within the last 6 months
- Subject who has, or has a family history of, an immune system disorder including immune deficiency disease
- Subject with a history of Guillain-Barre syndrome
- Subject with Down's syndrome or cytogenetic disorders.
- Subject with severe chronic disease which in the investigator's opinion would not make the subject a good candidate for the clinical trial
- Subject with hemophilia or being treated with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection
- Subject who had an acute fever with body temperature \> 38.0 Cº within 72 hours prior to administration of the study vaccine
- Subject who had previously received another vaccine within 28 days before administration of the study drug, or is scheduled to receive another vaccine during the study period.
- Subject who had received immunosuppressant or immune modifying drug within the last 3 months prior to administration of the study vaccine
- Subject who had previously received immunoglobulin or blood-derived products within the last 3 months prior to administration of the study vaccine, or is expecting to be treated with immunoglobulin or blood-derived products during the study.
- Subject who had participated in another experimental study within 28 days prior to administration of the study vaccine
- Subject with other clinically significant medical or psychological condition who in the investigator's opinion would not be suitable for the study.
Key Trial Info
Start Date :
September 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2018
Estimated Enrollment :
379 Patients enrolled
Trial Details
Trial ID
NCT03445468
Start Date
September 20 2017
End Date
August 30 2018
Last Update
May 11 2020
Active Locations (1)
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1
The catholic university of Korea, Seoul ST. Marry's Hospital
Seoul, South Korea, 06591