Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactived Split Influenza Vaccine in H… (NCT04381689) | Clinical Trial Compass
CompletedPhase 3
Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactived Split Influenza Vaccine in Healthy Infants
South Korea260 participantsStarted 2024-10-23
Plain-language 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)
Who can participate
Age range
6 Months – 3 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy infants 'from 6 months to under 3 years of age (≥6 months and \<3 years)
. Born after normal gestation period (which is more than 37 weeks)
. A subject's legally acceptable representative has voluntarily decided on participation and provided written informed consent after receiving and understanding a detailed explanation on this study
Exclusion criteria
. A history of severe hypersensitivity reactions (e.g., anaphylaxis) to eggs, chicken, and other components of a vaccine including those derived from chicken
. A history of influenza vaccination within 6 months prior to screening
. Immuno dysfunction including immunodeficiency diseases or a family history thereof
. A history of Guillain-Barre syndrome
. Down's syndrome or cytogenetic disorders
. Severe chronic diseases (e.g., cardiovascular diseases excluding controlled hypertension, respiratory diseases with respiratory failure, metabolic diseases, renal dysfunction, hemoglobinopathy, etc.) that, in the opinion of investigator, preclude a subject's participation in the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary immunogenicity endpoints
Timeframe: From a pre-vaccination (prior to vaccination with the IP, Visit1) to a post-vaccination (at Day 28 after the last vaccination with the IP)
2
Seroprotection rate against Hemagglutination
Timeframe: Up to Day28(+7) after the last vaccination