Trials / Active Not Recruiting
Active Not RecruitingNCT04381689
Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactived Split Influenza Vaccine in Healthy Korea Infants
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
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 245 (estimated)
- Sponsor
- Il-Yang Pharm. Co., Ltd. · Industry
- Sex
- All
- Age
- 6 Months – 3 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 Quadrivalent Seasonal Influenza Vaccine) in healthy infants from 6 months to under 3 years of age(≥ 6 months and \< 3 years)
Detailed description
The study is an Randomized, Double-blind, Active controlled Phase III study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IL-YANG FLU Vaccine Prefilled Syringe INJ. | Teratect Prefilled Syringe Inj. 0.5mL |
| BIOLOGICAL | Fluarix Tetra Pre-filled Syringe | Fluarix Tetra Pre-filled Syringe 0.5mL |
Timeline
- Start date
- 2024-10-23
- Primary completion
- 2025-05-20
- Completion
- 2026-05-31
- First posted
- 2020-05-11
- Last updated
- 2026-03-25
Locations
2 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04381689. Inclusion in this directory is not an endorsement.