Two-site Intradermal Influenza Vaccination in Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- immunogenicity
研究概览
简要总结
One-site dose sparing intradermal influenza vaccination in elderly had been studied but resulted in unsatisfactory outcomes. The investigators evaluate the safety and immunogenicity of the two-site intradermal injection of influenza vaccine containing all 6 and 12 micrograms of hemagglutinin antigen per strain (with 4/10th and 8/10th of a regular 15 microgram HA/strain intramuscular vaccine respectively) in elderly over 60 years of age. An influenza vaccine administered intramuscularly at the standard dose is used as the reference vaccine.
详细描述
The subjects would be randomly divided into three groups of 60 subjects each. Group1 receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of hemagglutinin antigen per strain, Group II receives two-site intradermal dose of 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site and group III receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site. Check for HA Antibody
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
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy male or female volunteer aged at least 60 years old
- •willing to participate in this study
排除标准
- •previous influenza vaccination within 6 months
- •systemic ypersensitivity to egg or chicken proteins or any of the vaccine components
- •history of a life-threatening reaction to the study vaccine or a vaccine containing the same constituents.
- •ongoing acute febrile illness (oral temperature, ≥37.5 c )
- •congenital or acquired immunodeficiency
- •treatment with immunosuppressive or other immune- modifying drugs or cancer therapy within previous 6 months
- •long-term treatment with systemic corticosteroids
- •receipt of blood or blood-derived products in the previous 3 months
- •history of thrombocytopenia or a bleeding disorder contraindicating for intramuscular vaccination.
研究组 & 干预措施
group 2
receives two-site intradermal dose of 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site
干预措施: seasonal influenza vaccine (Biological)
group 3
receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site
干预措施: seasonal influenza vaccine (Biological)
group 1
receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of hemagglutinin antigen per strain
干预措施: seasonal influenza vaccine (Biological)
结局指标
主要结局
immunogenicity
时间窗: 4 months
evaluate the immunogenicity of the two-site intradermal influenza vaccination containing all 6 and 12 micrograms of hemagglutinin antigen per strain (with 4/10th and 8/10th of a regular 15 microgram HA/strain intramuscular vaccine respectively) in elderly over 60 years of age , as measured by the titer of hemagglutination inhibition (HAI) antibodies, in order to determine whether it would meet the guidelines of the European Committee for Proprietary Medicinal Products (CPMP) for the annual relicensure of influenza vaccines
次要结局
- safety(4 months)
- comparison of the immunogenicity(4 months)
研究者
Suda Sibunruang
Principal investigator
Queen Saovabha Memorial Institute