NCT02269852已完成4 期
A Single-centered, Open-labeled, Phase 4 Study of a Northern Hemisphere 2013-2014 Seasonal Trivalent Influenza Inactivated Vaccine, Anflu®
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- The immunogenicity of 2013-2014 seasonal trivalent vaccine (TIV) in adults and seniors
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and safety of Northern hemisphere 2013-2014 seasonal trivalent inactivated influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy seniors aged > 60 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 18-60 years old, and healthy seniors aged > 60 years old;
- •Without vaccination history of seasonal split influenza vaccine in the recent 3 years
- •No traveling plan during the study period of this trial;
- •Be able to understand and sign the informed consent;
排除标准
- •Allergic to egg products or any ingredient of the study vaccine;
- •Fever, influenza or acute illness on the vaccination day;
- •Acute stage of chronic illness;
- •Malignant tumor;
- •Immunodeficiency, includes HIV infection;
- •Guillain-Barre syndrome;
- •Administration of live attenuated vaccine within the previous 14 days;
- •Administration of subunit or inactivated vaccine within the previous 7 days;
- •Planned to participate in any other clinical trial of drug or vaccine during this study;
- •Received immunesuppressive treatment within the previous month, or planned for such treatment during this study;
- •Pregnant, or planning pregnancy;
- •Axillary temperature > 37.0℃;
- •Any other factors that, in the judgment of the investigator, is unsuitable for this study;
- •For infants:
- •Inclusion Criteria:
- •Healthy male or female aged between 6 and 35 months;
- •Full-term birth, birth weight 2,500 grams or more;
- •Provided birth certification or vaccination card
- •Parent or legal guardian is able to understand and sign the informed consent;
- •Exclusion Criteria:
- •Received seasonal influenza vaccine after June 30, 2012;
- •Acute infection within the previous week;
- •Allergy history, or allergic to any ingredient of the study vaccine, such as egg;
- •History of serious adverse reaction (SAR) to vaccine;
- •Autoimmune disease or immune deficiency, or administration of immunosuppressive therapy, cell toxic therapy, or inhaled corticosteroid within the previous 6 months;
- •Congenital malformations, developmental disorder or serious chronic disease;
- •Unstable condition of asthma and administration of corticosteroid in the most recent two years;
- •Coagulation abnormalities or disorders;
- •History/ family history of infantile convulsion, epilepsy, cerebropathy, or mental disease;
- •Without spleen;
- •Severe neurological diseases, such as Guillain-Barre syndrome;
- •Administration of blood products or investigational drug within the previous month;
- •Administration of live attenuated vaccine within the previous 14 days;
- •Administration of subunit or inactivated vaccine within the previous 7 days;
- •Received treatment for allergy within the previous 14 days;
- •on-going anti-tuberculosis therapy;
- •Axillary temperature > 37.0℃ immediately before vaccination;
- •any other factors that, in the judgment of the investigator, is unsuitable for this study;
结局指标
主要结局
The immunogenicity of 2013-2014 seasonal trivalent vaccine (TIV) in adults and seniors
时间窗: 21 days after vaccination
To evaluate the immune responses to each antigen of the 2013-2014 seasonal TIV in adults and seniors by detection of hemagglutination inhibition (HI) antibody titer
次要结局
- The cross-reactivity of 2013-2014 seasonal TIV in adults and seniors against influenza B Victoria lineage virus and the avian influenza A(H7N9) virus(21 days after vaccination)
- The incidences of adverse events (AEs) in infants, adults and seniors(Day 0 - day 35)
研究者
研究点 (1)
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