Immunogenicity and Safety for 'IL-YANG Quadrivalent Influenza Vaccine' in Healthy Korean Children and Adolescents

NCT03445468 | Completed Phase 3 DMC

• 1 other identifier: IF4CH03
• Study Type: interventional
• Target: 379
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza, Human

Keywords

Influenza vaccine; Split influenza vaccine; Seasonal influenza vaccine

Outcome Measures

Primary Outcomes (2)

• Seroconversion rate against Hemagglutination Inhibition(HI) antibody

  Seroconversion rate(a lower bound of 95 CI) ≥ 40%

  Up to Day28(+7) after the last vaccination

• Seroprotection rate against Hemagglutination

  Seroprotection rate(a lower bound of 95 CI) ≥ 70%

  Up to Day28(+7) after the last vaccination

Secondary Outcomes (1)

• Geometric Mean Titer(GMT) and Geometric Mean Ratio(GMR)

  Up to Day28(+7) after the last vaccination

Study Arms (2)

IL-YANG Quadrivalent Influenza Vaccine

EXPERIMENTAL

The vaccine contains both B strain (Yamagata, Victoria)

Biological: IL-YANG Quadrivalent Influenza Vaccine

IL-YANG Flu Vaccine Pre-filled Syringe

ACTIVE COMPARATOR

The vaccine contains the B/Yamagata strain and it was approved for commercial sale by Ministry of Food and Drug Safety.

Biological: IL-YANG Flu Vaccine Pre-filled Syringe

Interventions

IL-YANG Quadrivalent Influenza Vaccine BIOLOGICAL

A single 0.5mL dose administrated as an intramuscular injection.

IL-YANG Quadrivalent Influenza Vaccine

IL-YANG Flu Vaccine Pre-filled Syringe BIOLOGICAL

A single 0.5mL dose administrated as an intramuscular injection.

IL-YANG Flu Vaccine Pre-filled Syringe

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Il-Yang Pharm. Co., Ltd.: lead

Study Sites (1)

The catholic university of Korea, Seoul ST. Marry's Hospital

Seoul, 06591, South Korea

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Jin-Han Kang, MD.PhD

  The catholic university of Korea, Seoul ST. Marry's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: February 26, 2018
• Study Start: September 20, 2017
• Primary Completion: December 29, 2017
• Study Completion: August 30, 2018
• Last Updated: May 11, 2020

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)