Healthy
Conditions
Keywords
Influenza, Influenza vaccine, Split influenza vaccine, Seasonal influenza vaccine
Brief 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)
Detailed description
The study is an Randomized, Double-blind, Active controlled Phase III study.
Interventions
Teratect Prefilled Syringe Inj. 0.5mL
BIOLOGICALFluarix Tetra Pre-filled Syringe
Fluarix Tetra Pre-filled Syringe 0.5mL
Sponsors
Il-Yang Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 3 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy infants 'from 6 months to under 3 years of age (≥6 months and \<3 years) 2. Born after normal gestation period (which is more than 37 weeks) 3. 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
1. A history of severe hypersensitivity reactions (e.g., anaphylaxis) to eggs, chicken, and other components of a vaccine including those derived from chicken 2. A history of influenza vaccination within 6 months prior to screening 3. Immuno dysfunction including immunodeficiency diseases or a family history thereof 4. A history of Guillain-Barre syndrome 5. Down's syndrome or cytogenetic disorders 6. 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 7. Risk of serious bleeding from an IM injection such as hemophilia patients or those on anticoagulants 8. Acute fever with body temperature exceeding 38.0℃ within 72 hours prior to vaccination with the IP 9. Vaccinated with other vaccines within 28 days prior to screening 10. 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. 11. Prior use of immunoglobulin or blood products within 3 months prior to screening or their anticipated use during the study 12. Took antipyretics, analgesics, or non-steroidal anti-inflammatory drugs (NSAIDs) within 4 hours prior to vaccination with the IP 13. Participated in another clinical study within 6 months prior to screening 14. Determined ineligible based on other clinically significant medical or psychiatric findings by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary immunogenicity endpoints | 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) | 1. (Seroconversion rate† is) Proportion of subjects achieving seroconversion\* for HI antibody after vaccination with the IP† † Seroconversion rate (SCR) \* Seroconversion: * A pre-vaccination (prior to vaccination with the IP, Day 0) HI antibody titer \<1:10 and a post-vaccination (at Day 28 after the last vaccination with the IP) HI antibody titer ≥1:40 * A pre-vaccination (prior to vaccination with the IP, Day 0) HI antibody titer ≥1:10 and at least a 4-fold increase in post-vaccination (at Day 28 after the last vaccination with the IP) HI antibody titer 2. (Seroprotection rate‡ is) Proportion of subjects achieving seroprotection\*\* for HI antibody after vaccination with the IP‡ ‡ Seroprotection rate (SPR) \*\* Seroprotection: HI antibody titer ≥1:40 at Day 28 after the last vaccination with the IP |
| Seroprotection rate against Hemagglutination | Up to Day28(+7) after the last vaccination | Seroprotection rate(a lower bound of 95 CI) ≥ 70% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer(GMT) | Up to Day28(+7) after the last vaccination | GMT of HI Antibody Titer Before Vaccination and After Vaccination |
| Geometric Mean Ratio(GMR) | Up to Day28(+7) after the last vaccination | GMR of HI Antibody Titer Before Vaccination and After Vaccination |
Countries
South Korea
Outcome results
None listed