NCT02677493

Brief Summary

This study evaluates the immunogenicity and safety of 'IL-YANG Quadrivalent Influenza Vaccine Inj.' in healthy male and female adults at the age of 19 or older.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,794

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

February 6, 2017

Completed
Last Updated

September 28, 2023

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

February 3, 2016

Results QC Date

June 21, 2016

Last Update Submit

September 26, 2023

Conditions

Influenza

Outcome Measures

Primary Outcomes (2)

  • Rate of Healthy Adults Aged ≥19 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.

    Day 28

  • Rate of Healthy Adults Aged ≥19 Years With Seroprotection

    Seroprotection: A post-vaccination (Day 28) HI antibody titer ≥ 1:40.

    Day 28

Secondary Outcomes (6)

  • Percentage of Subjects With SCR on Day 28 After Vaccination of the Investigational Product by Age Group

    Day 28

  • Rate of Healthy Adults Aged ≥19 ~ <65 Years and ≥65 Years With Seroprotection, Respectively.

    Day 28

  • Geometric Mean Titer as Measured by HI Antibody Titer on Day 28 After Vaccination of the Investigational Product (GMTcomparator/GMTtest Vaccine).

    Day 28

  • Difference of Seroconversion Rate(SCR) of HI Antibody Titer After 28days Vaccination(SCRcomparator-SCRtest Vaccine)

    Day 28

  • Geometric Mean Titer as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.

    Day 28

  • +1 more secondary outcomes

Study Arms (3)

IL-YANG Quadrivalent Influenza Vaccine

EXPERIMENTAL

The QIV is included both B strain (Yamagata, Victoria).

Biological: IL-YANG Quadrivalent Influenza Vaccine

IL-YANG Flu Vaccine Prefilled Syringe

ACTIVE COMPARATOR

This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.

Biological: IL-YANG Flu Vaccine Prefilled Syringe

IL-YANG Trivalent Influenza Vaccine

ACTIVE COMPARATOR

This TIV is included the B/Victoria strain.

Biological: IL-YANG Trivalent Influenza Vaccine

Interventions

IL-YANG Quadrivalent Influenza VaccineBIOLOGICAL

A single 0.5mL dose administrated as an intramuscular injection.

IL-YANG Quadrivalent Influenza Vaccine
IL-YANG Flu Vaccine Prefilled SyringeBIOLOGICAL

A single 0.5mL dose administrated as an intramuscular injection.

IL-YANG Flu Vaccine Prefilled Syringe
IL-YANG Trivalent Influenza VaccineBIOLOGICAL

A single 0.5mL dose administrated as an intramuscular injection.

IL-YANG Trivalent Influenza Vaccine

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy men and women at the age of 19 or older.
  • Women of childbearing potential must have a negative pregnancy test (urine HCG) at the screening visit.
  • Subjects who were given, and fully understood, the information about the study, and have provided voluntary written informed consent to participate in the study and to comply with all applicable study requirements.

You may not qualify if:

  • Subjects with known allergy to eggs, chicken, or any components of the study vaccine.
  • Subjects who had received an influenza vaccine within the last 6 months prior to study entry.
  • Subjects who have immune function disorders including immunodeficiency diseases or relevant family history.
  • Subjects who donated blood within 1 week prior to vaccination or plan to donate blood during the period from Day 1 to Month 7 of vaccination.
  • Subjects with a history of Guillain-Barre syndrome.
  • Subjects with Down's syndrome or cytogenetic disorders.
  • Subjects who are considered by the investigator to have difficulties in study participation due to severe chronic diseases (e.g., cardiovascular diseases except controlled hypertension and respiratory diseases with respiratory failure, metabolic diseases, renal function disorders, hemoglobinopathy, etc.).
  • Subjects with hemophilia or coagulation disorder, who are at increased risk of serious bleeding during intramuscular injection.
  • Subjects who had an acute fever with body temperature \> 38.0 ºC within 72 hours prior to administration of the study vaccine.
  • Subjects who had received another vaccine within 28 days before administration of the study vaccine or are planning to receive another vaccine during the study.
  • Subjects who had received immunosuppressants or immune modifying drugs within 3 months prior to the investigational product vaccination.
  • Azathioprine, cyclosporin, interferon, G-CSF, tacrolimus, everolimus, sirolimus, etc.
  • High dose corticosteroids (a subject taking high doses, which is defined as 2mg/kg/day or higher of prednisolone administered for longer than 14 consecutive days, is not eligible for this study. The use of inhaled, nasal and topical corticosteroids is allowed, regardless of doses).
  • Subjects who had previously received immunoglobulin or blood-derived products within the last 3 months prior to administration of the study vaccine, or are scheduled to receive a treatment with blood-derived products during the study.
  • Subjects who had participated in another clinical trial within the 30 days before administration of the study vaccine.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Clinical Research Manager
Organization
IL-YANG PHARM.
hlpark@ilyang.co.kr
+82-70-7165-7316

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 9, 2016

Study Start

October 1, 2015

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

September 28, 2023

Results First Posted

February 6, 2017

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share