A Randomized, Double-blind, Active-controlled Phase Ⅱ Clinical Trial to Evaluate the Immunogenicity and Safety of the Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Seroconversion rate
研究概览
简要总结
To evaluate the immunogenicity of administering one dose of influenza virus split vaccine (0.7mL/dose) to individuals aged 60 and above.
详细描述
This is a randomized, blinded, parallel controlled trial design, a total of 1200 participants aged ≥ 60 years were enrolled in the study. Study participants were randomly vaccinated with either the experimental vaccine: influenza virus split vaccine (0.7mL/dose) or the control vaccine: influenza virus split vaccine, at a 1:1 ratio. One dose of the vaccine was administered on day 0 for immunogenicity and safety evaluation.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age over 60 years old, gender not limited, and able to provide legal identification;
- •Volunteers voluntarily participate in the study and sign an informed consent form;
- •Volunteers have the ability to understand research procedures, use thermometers, scales, and fill out diary cards as required, and can participate in all planned follow-up visits.
排除标准
- •On the day of enrollment, the axillary temperature was ≥ 37.3 ℃;
- •Those who have had influenza in the past 6 months or meet the definition of influenza like cases;
- •Have received any influenza vaccine within the past 12 months or have planned to receive any influenza vaccine during the study period;
- •Allergies to any components of the research vaccine, history of allergic reactions to the use of gentamicin sulfate, history of severe allergies to any vaccine/drug, or history of asthma;
- •Suffering from a serious illness that prevents the completion of the entire study; Within 3 days prior to vaccination, there is an acute illness or an acute exacerbation of a chronic disease;
- •Have used antipyretic or analgesic drugs or anti allergic drugs within 3 days before vaccination;
- •Have received any vaccine within 2 weeks prior to vaccination;
- •Have received immunosuppressive therapy or other immunomodulatory drugs within 6 months prior to receiving the experimental vaccine, For example, immunosuppressive doses of glucocorticoids, monoclonal antibodies, thymosin, interferon, etc., or planned to receive such treatment within one month after the first dose of vaccination to full immunization, but local medication is allowed;
- •Suffering from congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, or other autoimmune diseases;
- •Suffering from serious chronic diseases, serious cardiovascular diseases, such as hypertension that cannot be controlled by drugs, diabetes that cannot be controlled by drugs or has serious complications, liver and kidney diseases, pulmonary edema, malignant tumors, etc;
- •Have received blood or blood related products within the past 6 months;
- •Individuals with progressive neurological disorders, including a history of seizures, epilepsy, encephalopathy, Guillain Barr é syndrome, psychiatric or family history;
- •Have a history of abnormal coagulation function and have been using anticoagulants within 3 weeks before vaccination;
- •Patients with splenectomy, functional splenectomy, splenectomy, or other important organ resection or partial resection;
- •Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit;
- •Currently or recently planning to participate in other clinical trials;
- •Researchers determine any situation that is not suitable for clinical trials.
研究组 & 干预措施
Experimental group
Influenza virus split vaccine (0.7mL/vial)
干预措施: Influenza virus split vaccine (0.7mL/vial) (Biological)
Control group
Influenza virus split vaccine
干预措施: Influenza virus split vaccine (Biological)
结局指标
主要结局
Seroconversion rate
时间窗: 30 days after vaccination
30 days after vaccination of all participants with the experimental vaccine or control vaccines, the HI antibody seroconversion rate against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Geometric mean titer (GMT)
时间窗: 30 days after vaccination
30 days after vaccination of all participants with the experimental vaccine or control vaccines, GMT of HI antibodies against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Ratio of ≥1:40
时间窗: 30 days after vaccination
30 days after vaccination of all participants with the experimental vaccine or control vaccines, the ratio of HI antibody titers ≥ 1:40 against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Geometric mean increase (GMI)
时间窗: 30 days after vaccination
30 days after vaccination of all participants with the experimental vaccine or control vaccines, GMI of HI antibodies against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
次要结局
- Unsolicited Adverse Events(30 days after vaccination)
- Serious Adverse Events (SAEs)(6 months after vaccination)
- Solicited Adverse Events (AEs)(7 days after vaccination)