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

NCT02263131 | Completed Phase 3 Results

• 1 other identifier: IY_IFEZ_CH_301
• Study Type: interventional
• Target: 416
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Influenza; Influenza vaccine; Split influenza vaccine; Seasonal influenza vaccine

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With Healthy Children Aged From 6 Months to <18 Years With Seroconversion

  Seroconversion is defined as follows. (Case 1) A pre-vaccination (Day 0) HI antibody titer \< 1:10 and a post-vaccination (Day 28) HI antibody titer ≥ 1: 40. or (Case 2) a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer.

  up to Day28(+7)

• Percentage of Subjects Achieving Seroconversion for HI Antibody After Administration of the Study Vaccine Depending of the Number of Vaccination

  Seroconversion: a pre-vaccination (Day 0) hemagglutination-inhibition (HI) antibody titer \< 1:10 and a post-vaccination (last vaccination + Day 28) HI antibody titer ≥ 1: 40 (Case 1), or a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (last vaccination + Day 28) HI antibody titer (Case 2),

  up to Day28(+7)

• Seroprotection Rate for HI Antibody

  Percentage of Participants With Healthy Children Aged From 6 Months to \<18 Years With Seroprotection

  up to Day28(+7)

• Seroprotection Rate of HI Antibody

  Percentage of subjects achieving seroprotection for HI antibody after administration of the study vaccine depending of the number of vaccination

  up to Day28(+7)

Secondary Outcomes (3)

• Geometric Mean Titer* (GMT) of HI Antibody

  Day28(+7)

• GMR of HI Antibody Titer Before Vaccination and After Vaccination

  Day28(+7)

• Number of Subjects With a Pre-vaccination (Day 0) HI Antibody Titer < 1:40, Minimum Four-fold Rise in Post-vaccination (Day 28) HI Antibody Titer

  Day28(+7)

Study Arms (2)

IL-YANG PFS

EXPERIMENTAL

IL-YANG FLU Vaccine Prefilled Syringe INJ.

Biological: IL-YANG FLU Vaccine Prefilled Syringe INJ.

TIV PFS

ACTIVE COMPARATOR

VAXIGRIP Prefilled Syringe INJ.

Biological: VAXIGRIP Prefilled Syringe INJ.

Interventions

IL-YANG FLU Vaccine Prefilled Syringe INJ. BIOLOGICAL

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

IL-YANG PFS

VAXIGRIP Prefilled Syringe INJ. BIOLOGICAL

VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL

TIV PFS

Eligibility Criteria

• Age: 6 Months - 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 6 months to \< 18 years
• Subjects were born after full term pregnancy (37 weeks)
• 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 10 years of age (and for subjects younger than 7 years of age for the some institutions)).

You may not qualify if:

• Subject with a known allergy to eggs, chicken, neomycin, gentamicin or any components of the study vaccine
• 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 30 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

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Kang Jin Han
• Organization: The Catholic University of Korea, Seoul St. Mary's Hospital

kjhan@catholic.ac.kr

+82-10-4251-8375

Study Officials

• Jin-Han Kang, MD.PhD

  Seoul St. Mary's Hospital, The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: September 23, 2014
• First Posted: October 13, 2014
• Study Start: October 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 9, 2020
• Results First Posted: April 6, 2015

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share