A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of 'NBP607-QIV(Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine)' in Children and Adolescents Aged 6 Months ~ 18 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 454
- 主要终点
- CHMP criteria
研究概览
简要总结
This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of the study is to describe the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.
详细描述
Subjects are randomly assigned in a 4:1 ratio to NBP607-QIV versus Agrippal S1. To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 28 days post-vaccination. To assess the safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination are assessed and reported. The serious adverse events are collected during 6 months post-vaccination.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children and adolescents aged 6 months to 18 years.
- •Those who was born after normal pregnancy period(37 weeks) for aged 6 months to < 1 year
- •Those whose legally acceptable representative have given written consent to participate in the study and comply with all study requirements.
排除标准
- •Subjects who are hypersensitive to any component of vaccine, i.e., eggs, chicken or chicken products.
- •Subjects with immune deficiency disorder or malignant cancer.
- •History of Guillain-Barre syndrome.
- •Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
- •Subjects who experienced fever within 72 hours before vaccination or with the febrile disease(exceeding 38.0℃) on screening day.
- •Subjects who had received immunosuppressant or immune-modifying drug within 3 months before screening.
- •Subjects who had received blood products or immunoglobulin within 3 months before screening.
- •Subjects who had received influenza vaccination within 6 months prior to the screening.
- •Subjects who had received other vaccination within a month before. screening, or those who had another vaccination scheduled within a month after study vaccination.
- •Subjects who had participated in other clinical trial within 4 weeks prior to study vaccination.
- •Subjects with clinically significant chronic disease.
- •Pregnant women, breast-feeding women.
- •Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
结局指标
主要结局
CHMP criteria
时间窗: At Day 28 post-vaccination
Seroprotection rate \> 70%, Seroconversion rate \> 40%, GMR \> 2.5
次要结局
- Incidence rate of Advers Event (AE)(During 7 days post-vaccination for Solicited AE and during 28 days post-vaccination for Unsolicited AE)
- Incidence rate of Severe Adverse Event (SAE)(During 6 months post-vaccination)
- Vital Sign(At Day 0 and at Day 28 post-vaccination)
- Immunogenicity in subjects with a pre-vaccination HI antibody titer < 1:80(At Day 28 post-vaccination)
- Immunogenicity compared to control group(At Day 28 post-vaccination)
- Physical Examination(At Day 0 and at Day 28 post-vaccination)