NCT02480998

Study to Evaluate the Safety and Immunogenicity of 'IL-YANG Flu Vaccine Quadrivalent Inj' in Healthy Korean Adults

A Randomized, Double-blind, Active Comparator, Phase I/Ⅱa Clinical Trial to Assess the Safety and Immunogenicity of the 'IL-YANG Flu Vaccine Quadrivalent Inj.' in Healthy Korean Adult Subjects

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Il-Yang Pharm. Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the safety, tolerability and immunogenicity of IL-YANG quadrivalent vaccine versus IL-YANG trivalent vaccine after a single intramuscular administration in healthy Korean males and females 19 to \< 65 years of age.

Detailed description

This is a randomized, double-blind, active-controlled, phase I/Ⅱa clinical trial. During the Part A phase, all safety data collected from the 12 subjects enrolled in the Part A phase will be analyzed to determine the safety and tolerability of the investigational product, which should include any solicited and unsolicited adverse drug reactions occurring for the first 7 days after vaccination and any adverse events occurring for 28 days after vaccination. Antibody titer test will be also performed to evaluate the efficacy (immunogenicity) of the investigational product. During the Part B phase, a total of 72 subjects will be enrolled, and all safety data (including all adverse events) and immunogenicity data will be analyzed.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	IL-YANG Flu Vaccine QIV 0.5mL
BIOLOGICAL	IL-YANG Flu Vaccine TIV 0.5mL

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2015-06-25
• Last updated: 2020-08-11
• Results posted: 2018-09-28