NCT07421050进行中（未招募）1 期
A Randomized, Blinded, Controlled Phase I Clinical Trial to Evaluate the Safety of a Subunit Influenza Vaccine (Adjuvant) in Adults Aged 65 Years and Older
Ab&B Bio-tech Co., Ltd.JS1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年11月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs) or reactions (ARs) within 30 minutes post-vaccination
研究概览
简要总结
The objective of this study was to evaluate the safety of subunit influenza vaccine (adjuvant) in people aged 65 years and older.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age at enrollment is ≥65 years (including the 65th birthday).
- •The participant voluntarily agrees to take part in the trial and has signed the informed consent form.
- •The participant is able to comply with the trial follow-up schedule as required by the protocol (i.e., no plans for long-term absence or relocation from the study site).
- •Medically stable: The participant may have underlying chronic conditions such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, but symptoms/signs must be controlled. If the participant is on any medication, the dosage must have remained stable for at least three weeks prior to vaccination.
排除标准
- •Axillary temperature >37.0°C.
- •Confirmed influenza virus infection by laboratory test or self-test kit positive within the past 12 months.
- •Received any influenza vaccine (licensed or investigational) within the past 12 months or plans to receive any influenza vaccine during the study.
- •Known or suspected allergic to any component of the investigational vaccine.
- •A history of severe allergic reactions to any vaccines or medications (for example, but not limited to: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reaction (Arthus reaction)).
- •Congenital malformations or developmental disorders, and genetic defects or severe malnutrition.
- •History of convulsions or seizures, epilepsy, psychiatric disorders, or relevant family history.
- •Severe liver and kidney diseases, malignant tumors, various acute diseases, or being in the acute exacerbation stage of a chronic disease.
- •Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other immune-mediated/autoimmune diseases.
- •A history of asthma, unstable within the past two years requiring emergency treatment, hospitalization, intubation, or oral/intravenous corticosteroids.
- •Individuals who have received immunostimulant or immunosuppressant therapy within the past 6 months (continuously administered orally or via drip infusion for more than 14 days).
- •Suffering from severe cardiovascular diseases (e.g., heart disease, cor pulmonale, pulmonary edema).
- •Blood pressure ≥150/100 mmHg despite medication control.
- •History of live attenuated vaccine within 28 days prior to vaccination, or any other vaccine within 14 days prior to vaccination.
- •Diagnosed with progressive neurological diseases, or a history of Guillain-Barré syndrome.
- •Asplenia or functional asplenia, including splenectomy due to any reason, or resection/partial removal of other vital organs.
- •Received blood or blood-derived products within the past 6 months.
- •A diagnosed history of coagulation disorders (e.g., coagulation factor deficiencies, coagulopathies, platelet disorders).
- •Currently undergoing anti-tuberculosis treatment.
- •Clinically significant abnormalities in laboratory tests (blood biochemistry, blood routine and urine routine) as determined by the investigator.
- •Any condition that, in the opinion of the investigator, makes the participant unsuitable for this clinical trial.
研究组 & 干预措施
Low-dose experimental vaccine
Experimental
干预措施: Subunit Influenza Vaccine (Adjuvant) (Biological)
High-dose experimental vaccine
Experimental
干预措施: Subunit Influenza Vaccine (Adjuvant) (Biological)
Adjuvant
Other
干预措施: MF59 (Biological)
Placebo
Placebo Comparator
干预措施: 0.9% sodium chloride injection (normal saline) (Biological)
结局指标
主要结局
Incidence of adverse events (AEs) or reactions (ARs) within 30 minutes post-vaccination
时间窗: Within 30 minutes post-vaccination
Incidence of adverse events (AEs) or reactions (ARs) within 0-7 days post-vaccination
时间窗: Within 0-7 days post-vaccination
Incidence of adverse events (AEs) or reactions (ARs) within 0-28 days post-vaccination
时间窗: Within 0-28 days post-vaccination
The incidence of laboratory abnormalities (including blood biochemistry, blood routine and urine routine ) on Day 3 post-vaccination.
时间窗: On Day 3 post-vaccination
The incidence of serious adverse events (SAEs) and Adverse Events of Special Interest (AESI) within 12 months post-vaccination.
时间窗: Within 12 months post-vaccination.
次要结局
未报告次要终点
研究者
研究点 (1)
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