Comparative Immune Response of Intradermal and Intramuscular Preparations of
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Immunological end point
研究概览
简要总结
This is a prospective, Open label randomized study. A total of 220 adults aged ≥ 60 years will be enrolled and randomized to one of 2 study arms:
- Seasonal inactivated intradermal influenza vaccine (15 μg HA (hemagglutinin) per strain/ 0.1 ml dose) (group A - 110 participants)
- Seasonal inactivated intramuscular influenza vaccine (15 μg HA per strain/ 0.5 ml dose) (group B - 110 participants) Groups A and B will receive the vaccine at day 1. Total follow up period is 60 days.
详细描述
The consent form will be reviewed and signed by the participant prior to any study-related procedures.
Potential study participants will be assessed based on inclusion and exclusion criteria. Screening procedures, which include taking medical history, vital signs, random blood for dextrostix and vaccination will be performed on day 1.
A total of 220 participants will be randomized into 2 study arms, of which each group of 110 vaccinees will receive either seasonal intradermal influenza vaccine [group A] or seasonal intramuscular influenza vaccine [group B]. The randomization route of vaccination will be kept in concealed envelope at the study site. It will be open after subject signed informed consent form and all inclusion exclusion criteria met for enrollment. Groups A and B will receive the vaccine at day 1. Clinical activities for groups A and B during each visit (total of 5 visits). Blood will be drawn and assayed (for baseline assessment) using HAI (hemagglutination inhibition assay) to the three influenza strains.
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
- None
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
- •Male or female aged ≥ 60 years
- •Healthy and/or medically stable with controlled chronic medical conditions (e.g. diabetes mellitus, hypertension ) able to help oneself
排除标准
- •Known history of systemic hypersensitivity to egg or chicken proteins or any of the vaccine components
- •Influenza infection within the past 3 months
- •History of Guillain Barre Syndrome (GBS) or brachial neuritis within 6 weeks of previous influenza vaccination
- •Treatment with immunosuppressive or other immune-modifying drugs or cancer therapy within the past 6 months
- •Any concomitant medication with aspirin
- •Participation in other intervention study
- •Incapacity to provide fully informed consent or be attentive to follow-up observations resulting from cognitive impairment, abuse of alcohol or drug addiction
- •Random blood for Dextrostix more than 200 mg/dL
研究组 & 干预措施
trivalent inactivated influenza (INTANZA)
Intradermal injection
干预措施: trivalent inactivated influenza (Biological)
trivalent inactivated influenza (VAXIGRIP)
Intramuscle injection
干预措施: trivalent inactivated influenza (Biological)
结局指标
主要结局
Immunological end point
时间窗: with in 60 days post vaccination
Vaccine is able to induce a 4-fold rise of Hemagglutination inhibition antibodies 70% of vaccinees within 60 days after vaccination (according to EMA (European Medicines Agency) and CBER (Center for Biologics Evaluation and Research) guidelines)
次要结局
- To assess safety(60 Days)