Immunogenicity and Safety of an Alum-adjuvanted Inactivated H7N9 Influenza Vaccine: a Randomized, Blind, Placebo-controlled, a Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)
研究概览
简要总结
The aim of this study is to investigate the immunogenicity and safety of the inactivated whole-virion vaccine for teenagers and adults.
The investigators will test the vaccine in participants aged above 12 years, for a randomized, blind, placebo-controlled, clinical study. The investigators designed one dosage groups: 15 μg of hemagglutinin antigen. Control group is designed to inoculate seasonal influence vaccine and aluminum hydroxide adjuvant. Participants will receive 2 doses of vaccine at 21-day intervals. Safety up to 6 months and changes in hemagglutinin inhibition (HI) titers at 21 days after each vaccination will be determined.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over the age of 12 years, healthy population
- •Subjects/ (and the guardian) informed consent, voluntarily participated and signed the informed consent form, with the ability to use thermometers, scales and to fill in diary cards as required
- •To comply with the requirements of clinical trial program, receive blood test before and after immunization and cooperate with follow-up
排除标准
- •A history of influenza A (H7N9) virus infection or suspected infection Abnormal blood routine, blood biochemistry and urine routine examination indexes
- •Allergy to any component in the vaccine (allergy history of any previous vaccination), especially for egg allergy
- •History of asthma, history of thyroid resection, vascular nerve edema, diabetes mellitus, hypertension can not be controlled by medicine, liver and kidney diseases or malignant tumor history
- •Suffered from any serious illness, such as cancer, autoimmune disease, progressive atherosclerotic disease or complications of diabetes, chronic obstructive pulmonary disease, need oxygen therapy for acute or progressive liver or kidney disease, congestive heart-failure etc.
- •History of signs disease or symptoms of neurological symptoms
- •Suffering from severe chronic diseases (such as Down's syndrome, diabetes, sicklemia or neurological disorders, Green's Barre syndrome)
- •Acute attacks of various acute or chronic diseases in the past 7 days
- •Known or suspected of respiratory disease, acute infection or chronic disease active period, HIV infection, cardiovascular disease, severe hypertension, malignant tumor during treatment, skin diseases
- •Congenital malformations or developmental disorders, genetic defects, severe malnutrition etc
- •No spleen, functional absence of spleen, and splenectomy or splenectomy without any condition
- •Autoimmune diseases or immunodeficiency have been treated with immunosuppressive agents in the past 6 months
- •History of epilepsy, convulsions, or a family history of psychosis
- •Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities), or obvious bruising or coagulopathy
- •The blood products were received within 3 months prior to the acceptance of the vaccine
- •Received a live vaccine within 14 days prior to receiving the vaccine, or received a subunit or inactivated vaccine within 7 days
- •Fever within 3 days prior to vaccination, axillary temperature ≥38 ℃
- •Being febrile When inoculating vaccine, axillary temperature >37.0 ℃
- •Women are pregnant or in the near future planned pregnancy or pregnancy test positive
- •Participants in another clinical trial
研究组 & 干预措施
15μg H7N9 Vaccine
Participants will be inoculated with 2 doses of 15μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals.
干预措施: 15μg H7N9 Vaccine (Biological)
Aluminum hydroxide adjuvant
Participants will be first inoculated with one dose of seasonal influenza vaccine and followed with one dose of aluminum hydroxide adjuvant at 21-day intervals.
干预措施: Aluminum Hydroxide Adjuvant (Biological)
结局指标
主要结局
Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)
时间窗: Continuous observation for 30 days after two inoculations
* For each group the incidence rate of subjects with solicited AE(s) with 95% confidence interval * For each group the incidence rate of subjects with unsolicited AE(s) with 95% confidence interval
次要结局
- Number of participants that presented seroconversion post injection(21 days after two inoculations)
- Number of participants that presented seroprotection post injection(21 days after two inoculations)
- Geometric mean of Hemagglutination-inhibition titre post first study injection(21 days after two inoculations)