A Randomized, Double-blinded, Controlled, Phase I/II Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of NBP607QIV Compared to Trivalent Egg-based Influenza Vaccine in Healty Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Incidence rate of solicited local adverse events(AEs)
研究概览
简要总结
This study assesses safety, tolerability and immunogenicity of NBP607QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease.
详细描述
Subjects are randomly assigned in a 1:1 ratio to NBP607QIV versus Agrippal S1. 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. To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 21 days 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
- 19 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 19 to 59 years
- •Those who are able and willing to give written informed consent to study participation and compliance with study instructions after being informed of and understand details of the study
- •If female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening
排除标准
- •Those with hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
- •Those with Immunodeficiency disease
- •Those with history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
- •Those who are contraindicated for intramuscular injection due to thrombocytopenia or coagulopathy
- •Those who experienced fever (>38°C) within the past 24 hours or any acute respiratory infection
- •Those with history of treatment with any of Immunosuppressants or Immunomodulators within the past 3 months
- •Those with history of receiving blood products or immunoglobulin within the past 3 months
- •Those with history of influenza vaccination within the past 6 months
- •Those who received another vaccine within the past 1 month or have plan to receive another vaccine within 1 months following the study vaccination
- •Those with history of participation on another clinical trial within 1 month prior to the study vaccination
- •Those with history of blood donation within 1 week prior to the study vaccination or plan of blood donation within 7 days following the study vaccination
- •Those with any chronic diseases that interfere with the clinical trial or malignant tumors
- •Pregnant or breastfeeding
- •Those with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might interfere with the safety of the study subject.
研究组 & 干预措施
NBP607QIV
1 dose of 0.5mL by Intramuscular injection
干预措施: NBP607QIV (Biological)
Agrippal
1 dose of 0.5mL by Intramuscular injection
干预措施: Agrippal (Biological)
结局指标
主要结局
Incidence rate of solicited local adverse events(AEs)
时间窗: 7 days after vaccination
All AEs were classified and analyzed according to its severity and causality. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated. Comparisons within each group between pre-/post- vaccination were summarized and presented. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
Incidence rate of solicited systemic AEs
时间窗: 7 days after vaccination
The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
Incidence rate of unsolicited AEs
时间窗: 21 days after vaccination
The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
次要结局
- 9. Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity](21-28 days after vaccination)
- Seroprotection rate measured by post-vaccination Haemagglutination Inhibition(HI) titer[Immunogenicity](21-28 days after vaccination)
- Seroconversion rate measured by pre-/post-vaccination HI titerImmunogenicity](21-28 days after vaccination)