Immune Response of Intradermal and Intramuscular Preparations of Inactive Seasonal Influenza Vaccine in Older Age Group.
Comparative Immune Response of Intradermal and Intramuscular Preparations of
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Bangkok、泰国、10400
- Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University,
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria:
- 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
Exclusion criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：trivalent inactivated influenza (INTANZA)
Intradermal injection
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intradermal or intramuscular injection in the deltoid area.
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有源比较器：trivalent inactivated influenza (VAXIGRIP)
Intramuscle injection
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intradermal or intramuscular injection in the deltoid area.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Immunological end point
大体时间：with in 60 days post vaccination
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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)
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with in 60 days post vaccination
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To assess safety
大体时间：60 Days
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To assess safety of the following trivalent inactivated seasonal influenza vaccine in the older age group
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60 Days
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Assess other related immune response
大体时间：60 days
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Exploratory objective to assess other related immune response (e.g.
anti-neuraminidase)
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60 days
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合作者和调查者
调查人员
- 首席研究员：Punnee Pitisuttithum, MD、Mahidol University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.