NCT02111070

Immunogenicity and Safety Study of Inactivated Split Influenza Vaccine' in Healthy Korean Male Subjects

Open-label, Phase I Clinical Trial to Assess the Immunogenicity and Safety of the 'IL-YANG Inactivated Split Influenza Vaccine' in Healthy Korean Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Il-Yang Pharm. Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG FLU Vaccine Vial INJ.) administered as a single intramuscular injection

Detailed description

This was an open-label study. Subjects providing voluntary written informed consent underwent protocol-specific assessments and tests within 4 weeks prior to administration of the study vaccine, and those who met all of the inclusion/exclusion criteria and were considered eligible were sequentially enrolled in the study. Subjects enrolled in the study received 0.5ml of the study vaccine as an intramuscular injection in the deltoid muscle, and returned to the clinic every day for the first 3 days. On Day 14 post-vaccination, subjects underwent the safety assessments. On Day 28 post-vaccination, subjects returned for safety and immunogenicity assessments.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	IL-YANG FLU Vaccine	0.5mL

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2014-04-10
• Last updated: 2014-04-10

Locations

1 site across 1 country: South Korea