NCT02154308

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

A Multicenter, Open-Label, Phase 3 Clinical Study to Evaluate the Immunogenicity and Safety of IL-YANG Inactivated Split Influenza Vaccine in Healthy Adults 18 to < 65 Years of Age and in Healthy Adults ≥ 65 Years of Age.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 787 (actual)
• Sponsor: Il-Yang Pharm. Co., Ltd. · Industry
• Sex: All
• Age: 18 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 Prefilled Syringe INJ.) administered as a single intramuscular injection.

Detailed description

This is a multicenter, open-label study. Subjects who have provided written informed consent will undergo the protocol-specific assessments to determine their eligibility for the study. Subjects considered eligible will be assigned to an appropriate age stratum, and will be given a single dose of the study vaccine. For each age stratum, the first 142 subjects enrolled will be evaluated for both immunogenicity and safety, and the remaining subjects subsequently enrolled will be evaluated only for the safety of the study vaccine. 1. Group A: healthy adults 18 to \< 65 years of age 2. Group B: healthy adults ≥ 65 years of age The investigator will evaluate the immunogenicity and safety of the study vaccine throughout the study. The immunogenicity assessment will be performed at Visit 1 (pre-vaccination) and at the End-of-Study Visit. For safety measurements, subjects will be instructed to record any adverse events occurring after vaccination in the Patient Diary card. Subjects who are assigned for the both immunogenicity and safety assessment will have their blood sample drawn for antibody titer (immunogenicity) testing, and afterward, receive 0.5 mL of the study vaccine by intramuscular injection at deltoid muscle. Subjects will return to the clinic for follow-up visit 4 to 5 weeks after the vaccination, and undergo another blood sampling for antibody titer test. The long-term safety for up to 6 months after vaccination will be also evaluated. Subjects who are assigned for only safety assessments will not undergo blood sampling, but have the same visit schedule as those assigned for the both immunogenicity and safety assessments.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	IL-YANG FLU Vaccine Prefilled Syringe INJ 0.5mL	IL-YANG FLU Vaccine Prefilled Syringe INJ 0.5mL by intramuscular injection

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-03-01
• Completion: 2013-08-01
• First posted: 2014-06-03
• Last updated: 2014-06-03

Locations

1 site across 1 country: South Korea