NCT02677493

Study to Evaluate the Immunogenicity and Safety of 'IL-YANG Quadrivalent Influenza Vaccine Inj.'

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Immunogenicity and Safety of 'IL-YANG Quadrivalent Influenza Vaccine Inj.' After Intramuscular Administration in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,794 (actual)
• Sponsor: Il-Yang Pharm. Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Detailed description

In this study, only eligible subjects for the study based on the inclusion/exclusion criteria will be randomized to the following stratification groups by age to receive one dose of the test vaccine, comparator 1, or comparator 2. * Group A: healthy adults at the age of ≥ 19 and \< 65. * Group B: healthy adults at the age of ≥ 65. During the study participation, the investigator will assess immunogenicity and safety in subjects. The investigator will perform immunogenicity tests at Visits 1 and 3 (end of study visit) for immunogenicity evaluation (prior to the investigational product vaccination) and instruct subjects to record AEs occurring after the investigational product vaccination for safety assessment. A blood sample will be collected from a subject who is assigned a subject number. Following an intramuscular injection of 0.5mL investigational product in the deltoid muscle of the shoulder, the subject will have a study visit on Week 4 for blood sampling for antibody titer testing. In addition, a telephone visit will be performed to assess serious AEs (SAEs) up to Day 180 after vaccination.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	IL-YANG Quadrivalent Influenza Vaccine	A single 0.5mL dose administrated as an intramuscular injection.
BIOLOGICAL	IL-YANG Flu Vaccine Prefilled Syringe	A single 0.5mL dose administrated as an intramuscular injection.
BIOLOGICAL	IL-YANG Trivalent Influenza Vaccine	A single 0.5mL dose administrated as an intramuscular injection.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-01-01
• Completion: 2016-06-01
• First posted: 2016-02-09
• Last updated: 2023-09-28
• Results posted: 2017-02-06