Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactived Split Influenza Vaccine in H… (NCT04381689) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactived Split Influenza Vaccine in Healthy Korea Infants
South Korea245 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 range6 Months – 3 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 modi…
What they're measuring
1
Seroconversion rate against Hemagglutination Inhibition(HI) antibody
Timeframe: Up to Day28(+7) after the last vaccination
2
Seroprotection rate against Hemagglutination
Timeframe: Up to Day28(+7) after the last vaccination