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

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

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
• Risk of serious bleeding from an IM injection such as hemophilia patients or those on anticoagulants
• Acute fever with body temperature exceeding 38.0℃ within 72 hours prior to vaccination with the IP
• Vaccinated with other vaccines within 28 days prior to screening
• Received immunosuppressants or immune-modifying drugs within 3 months prior to screening

① Azathioprine, cyclosporin, interferon, granulocyte colony-stimulating factor (G-CSF), tacrolimus, everolimus, sirolimus, etc.

② Use of high-dose corticosteroids (e.g., continued use of prednisolone at a dose of ≥2 mg/kg/day in subjects weighing <10 kg for 14 days or longer or at a dose of ≥20 mg/day in subjects weighing ≥10 kg for 14 days or longer). However, inhaled, intranasal, or topical corticosteroids are permitted regardless of their dose.

• Prior use of immunoglobulin or blood products within 3 months prior to screening or their anticipated use during the study
• Took antipyretics, analgesics, or non-steroidal anti-inflammatory drugs (NSAIDs) within 4 hours prior to vaccination with the IP
• Participated in another clinical study within 6 months prior to screening
• Determined ineligible based on other clinically significant medical or psychiatric findings by the investigator