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

Healthy Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04381689
• Other study ID #: IF4IC03
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Il-Yang Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

The study is an Randomized, Double-blind, Active controlled Phase III study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 245
• Est. completion date: June 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Influenza, Human

Intervention

Biological:
• IL-YANG FLU Vaccine Prefilled Syringe INJ.
Teratect Prefilled Syringe Inj. 0.5mL
• Fluarix Tetra Pre-filled Syringe
Fluarix Tetra Pre-filled Syringe 0.5mL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Il-Yang Pharm. Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion rate against Hemagglutination Inhibition(HI) antibody	Seroconversion rate(a lower bound of 95 CI) = 40%	Up to Day28(+7) after the last vaccination
Primary	Seroprotection rate against Hemagglutination	Seroprotection rate(a lower bound of 95 CI) = 70%	Up to Day28(+7) after the last vaccination
Secondary	Geometric Mean Titer(GMT)	GMT of HI Antibody Titer Before Vaccination and After Vaccination	Up to Day28(+7) after the last vaccination
Secondary	Geometric Mean Ratio(GMR)	GMR of HI Antibody Titer Before Vaccination and After Vaccination	Up to Day28(+7) after the last vaccination