Safety and Immunogenicity of GPO Seasonal Trivalent Inactivated Influenza Vaccine in Healthy Thai Adults
2020年3月8日 更新者：Punnee Pitisuttithum、Mahidol University
A Phase I/II Randomized Double Blind Controlled Study to Evaluate the Safety and Immunogenicity of GPO Seasonal Trivalent Inactivated Split Virion Influenza Vaccine in Healthy Thai Adults Aged Between 18 Years to 49 Years
The study is aim to evaluate the safety and immunogenicity of one dose (15 μg HA per strain per dose) of the GPO seasonal trivalent inactivated split virion influenza vaccine (Tri Fluvac) in healthy adults aged 18 to 49 years over 90 days post-injection.
研究概览
详细说明
This is a double blind randomized study consisting of two phases - Phase I and Phase II. The same vaccine, a seasonal trivalent inactivated split virion influenza vaccine [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains] will be given in both Phase I and Phase II of the study.
The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. After vaccination volunteers will remain at the clinic for at least 30 minutes to observe for any reactogenicity after immunization. Total follow-up is 90 days.
Blood specimens will be collected on Day 0 prior to vaccination, Day 21, Day 60, and day 90.
研究类型
介入性
注册 (实际的)
340
阶段
- 阶段2
- 阶段1
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 49年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Healthy
- Age 18-49 years old
- Having Thai ID card or equivalent
- All hematology, biochemistry and urine analysis are within normal range or of no clinical significance (not higher than 1.5 time of normal value without any clinical finding from history and physical examination)
- Able to read and write and sign written informed consent form or assent form.
Exclusion Criteria:
- Known history of egg allergy
- Having had recently influenza infection confirmed as H1N1, H3N2, or Flu B within 3 months preceding enrolment to the trial
- Vaccination against influenza in the past 6 months preceding enrolment to the trial
- History of bronchial asthma, chronic lung diseases, chronic rhinitis
- History of immunodeficiency state
- History of immunosuppression < 6 months prior to immunization
- History of anaphylactic or other allergic reactions to influenza vaccine or any vaccine component or excipient (e.g. gentamicin or thimerosal)
- Acute infectious with fever > 38 degree Celsius and noninfectious diseases (within 72 hours) preceding enrollment in the trial
- The volunteers who have been taking immunoglobulin products or have had a blood transfusion during past 3 months before the beginning of the experiment
- Participation in other research study
- Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding
- Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled, or could interfere with the evaluation of the vaccine
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：an inactivated influenza vaccine
20 volunteers in phase I study and 200 volunteers in phase II study will receive a single dose of a seasonal trivalent inactivated split virion influenza vaccine [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains] will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
|
The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
|
|
安慰剂比较：Placebo
20 volunteers in phase I study and 100 volunteers in phase II study will receive a single dose of placebo will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
|
The placebo will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
|
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 |
|---|---|---|
|
Number of Participants With Adverse Events
大体时间：90 days
|
All Adverse Events during 90 days will be analysed in terms of percentage and relationship to study vaccine
|
90 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer.
大体时间：90 days
|
Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.
|
90 days
|
|
Geometric Mean of Immune Response at Every Time of Assessment
大体时间：90 days
|
The analysis was performed only as intention-to-treat (ITT).
The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0,21, 60 and 90)
|
90 days
|
|
Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer
大体时间：90 days
|
The analysis was performed only as intention-to-treat (ITT).
The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0, 21, 60 and 90).
Proportion of increased in GMT Titer > 2.5 at each time of assessment compared with baseline (Day 0) was reported both phase I and phase II
|
90 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Punnee Pitisuttithum, Prof.、Mahidol University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年11月1日
初级完成 (实际的)
2016年7月1日
研究完成 (实际的)
2016年11月1日
研究注册日期
首次提交
2016年8月24日
首先提交符合 QC 标准的
2016年9月5日
首次发布 (估计)
2016年9月9日
研究记录更新
最后更新发布 (实际的)
2020年3月17日
上次提交的符合 QC 标准的更新
2020年3月8日
最后验证
2020年3月1日
更多信息
与本研究相关的术语
其他研究编号
- GPO Tri Fluvac Vaccine
计划个人参与者数据 (IPD)
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