Evaluating a new influenza vaccine for healthy infants in Korea
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)
This study is testing a new flu vaccine for healthy infants aged 6 months to under 3 years to see if it is safe and works better than a standard flu vaccine.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 245 (estimated) |
| Ages | 6 Months to 3 Years |
| Sex | All |
| Sponsor | Il-Yang Pharm. Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Ansan-si, Gyeonnggi-do and 1 other locations) |
| Trial ID | NCT04381689 on ClinicalTrials.gov |
What this trial studies
This Phase 3 study aims to assess the safety and immunogenicity of the IL-YANG Inactivated Split Influenza Vaccine in healthy infants aged 6 months to under 3 years. The study employs a randomized, double-blind, active-controlled design to compare the new vaccine with an established influenza vaccine. Participants will receive either the IL-YANG vaccine or the Fluarix Tetra vaccine, and their immune responses will be monitored to determine the effectiveness and safety of the new vaccine. The study is crucial for understanding how well this vaccine can protect young children from influenza.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy infants aged 6 months to under 3 years who have not received an influenza vaccine in the past 6 months.
Not a fit: Patients with known allergies to vaccine components or those with certain medical histories, such as immune disorders or severe chronic diseases, may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could provide enhanced protection against influenza for infants, reducing illness and hospitalizations.
How similar studies have performed: Other studies evaluating similar influenza vaccines have shown promising results, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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)). Exclusion Criteria: * Subject with a known allergy to eggs, chicken, neomycin, gentamicin or any components of the study vaccine * Subject who had received an influenza vaccine within the last 6 months * Subject who has, or has a family history of, an immune system disorder including immune deficiency disease * Subject with a history of Guillain-Barre syndrome * Subject with Down's syndrome or cytogenetic disorders. * Subject with severe chronic disease which in the investigator's opinion would not make the subject a good candidate for the clinical trial * Subject with hemophilia or being treated with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection * Subject who had an acute fever with body temperature \> 38.0 Cº within 72 hours prior to administration of the study vaccine * Subject who had previously received another vaccine within 28 days before administration of the study drug, or is scheduled to receive another vaccine during the study period. * Subject who had received immunosuppressant or immune modifying drug within the last 3 months prior to administration of the study vaccine * Subject who had previously received immunoglobulin or blood-derived products within the last 3 months prior to administration of the study vaccine, or is expecting to be treated with immunoglobulin or blood-derived products during the study. * Subject who had participated in another experimental study within 30 days prior to administration of the study vaccine * Subject with other clinically significant medical or psychological condition who in the investigator's opinion would not be suitable for the study.
Where this trial is running
Ansan-si, Gyeonnggi-do and 1 other locations
- Korea University ANSAN Hospital — Ansan-si, Gyeonnggi-do, Korea, Republic of (Not_yet_recruiting)
- The Catholic University of Korea, Bucheon St. Mary's Hospital — Bucheon-si, Gyeonnggi-do, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Na Yun Kim
- Email: nykim@ilyang.co.kr
- Phone: 82-70-7165-7316
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.