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

Launched by IL-YANG PHARM. CO., LTD. · May 8, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a new flu vaccine called the IL-YANG Inactivated Split Influenza Vaccine for healthy infants aged 6 months to under 3 years. The main goal is to see how well this vaccine works in helping young children build protection against the flu and to ensure that it is safe for them to receive.

To participate in the study, children must be healthy and born after a full-term pregnancy (at least 37 weeks). Importantly, parents or guardians will need to give their written consent for their child to join. However, there are some children who cannot participate, such as those with allergies to certain vaccine components or those who have had a flu vaccine in the last six months. If your child is selected, they will receive the vaccine and will be monitored for any side effects, helping researchers understand how well it works and if it's safe for young children.

Gender

ALL

Eligibility 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.