Phase Ⅲ, Randomized, Double-blind, Active Controlled to Evaluate the Immunogenicity and Safety of IL-YANG Quadrivalent Seasonal Influenza Vaccine in Healthy Infants From 6 Months to Under 3 Years of Age(≥ 6 Months and < 3 Years)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG Quadrivalent Seasonal Influenza Vaccine) in healthy infants from 6 months to under 3 years of age(≥ 6 months and \< 3 years)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 3
Healthy Volunteers: t
View:
• Healthy men or women aged from 6 months to \< 3 years
• Subjects were born after full term pregnancy (37 weeks)
• Voluntary written informed consent was obtained from the subject and the subject's legally acceptable representative (consent of legally acceptable representative was required for subjects younger than 10 years of age (and for subjects younger than 7 years of age for the some institutions)).
Locations
Other Locations
Republic of Korea
Korea University ANSAN Hospital
NOT_YET_RECRUITING
Ansan-si
The Catholic University of Korea, Bucheon St. Mary's Hospital
RECRUITING
Bucheon-si
Contact Information
Primary
Na Yun Kim
nykim@ilyang.co.kr
82-70-7165-7316
Time Frame
Start Date: 2024-10-23
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 245
Treatments
Experimental: IL-YANG PFS
IL-YANG FLU Vaccine Prefilled Syringe INJ.
Active_comparator: GSK PFS
Fluarix Tetra Pre-filled Syringe
Related Therapeutic Areas
Sponsors
Leads: Il-Yang Pharm. Co., Ltd.