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 Aged 6~35 Months
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 12
- 主要终点
- HI[hemagglutination Inhibition] derived parameters: Seroprotection rate(a lower bound of 95% CI) > 70%
研究概览
简要总结
This study is a multi-center, randomized, double-blind Phase III Clinical trial. The purpose of this study is to assess the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compare to the trivalent cell culture-derived influenza vaccine in children aged 6~35 months.
详细描述
Subjects are randomly assigned in a 2:1 ratio to NBP607-QIV 0.5mL versus NBP607-TIV 0.25mL. 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 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6 months to 35 months
- •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 with immune deficiency disorder or malignant cancer.
- •History of any hypersensitivity following administration of vaccine or 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 received any other investigational products within 4 weeks prior to study vaccination.
- •Subjects with clinically significant chronic disease.
- •Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
研究组 & 干预措施
NBP607-TIV 0.25mL
Trivalent Inactivated Cell Culture-derived Influenza Vaccine
干预措施: NBP607-TIV (Biological)
NBP607-QIV 0.5mL
Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine
干预措施: NBP607-QIV (Biological)
结局指标
主要结局
HI[hemagglutination Inhibition] derived parameters: Seroprotection rate(a lower bound of 95% CI) > 70%
时间窗: At Day 28 post-vaccination
Seroprotection rate is the proportion of subjects achieving a post-vaccination HI titer ≥ 1:40
HI[hemagglutination Inhibition] derived parameters: Seroconversion rate(a lower bound of 95% CI) > 40%
时间窗: At Day 28 post-vaccination
Seroconversion is defined as a pre-vaccination HI titer of \<1:10 with a post-vaccination titer ≥ 1:40, and a significant increase was defined as at least a four fold increase in HI titer
HI[hemagglutination Inhibition] derived parameters: GMR (a lower bound of 95% CI) > 2.5
时间窗: At Day 28 post-vaccination
GMR \[geometric mean ratio, mean fold increase\]
次要结局
未报告次要终点