Phase Ⅲ, Multi-national, 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)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Seroconversion rate against Hemagglutination Inhibition(HI) antibody
研究概览
简要总结
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)
详细描述
The study is an Randomized, Double-blind, Active controlled Phase III study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
IL-YANG FLU Vaccine Prefilled Syringe INJ.
Teratect Prefilled Syringe Inj. 0.5mL
干预措施: IL-YANG FLU Vaccine Prefilled Syringe INJ. (Biological)
GSK FLU Vaccine Prefilled Syringe INJ.
Fluarix Tetra Pre-filled Syringe 0.5mL
干预措施: Fluarix Tetra Pre-filled Syringe (Biological)
结局指标
主要结局
Seroconversion rate against Hemagglutination Inhibition(HI) antibody
时间窗: Up to Day28(+7) after the last vaccination
Seroconversion rate(a lower bound of 95 CI) ≥ 40%
Seroprotection rate against Hemagglutination
时间窗: Up to Day28(+7) after the last vaccination
Seroprotection rate(a lower bound of 95 CI) ≥ 70%
Primary immunogenicity endpoints
时间窗: 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
次要结局
- Geometric Mean Titer(GMT)(Up to Day28(+7) after the last vaccination)
- Geometric Mean Ratio(GMR)(Up to Day28(+7) after the last vaccination)