A Phase I/II Randomized Double Blind Controlled Study to Evaluate the Safety and Immunogenicity of GPO Seasonal Tetravalent Inactivated Split Virion Influenza Vaccine in Healthy Thais
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Number and percentage of Solicited local adverse events post-vaccination.
研究概览
简要总结
The study is aim to evaluate the safety and immunogenicity of one dose TetraFluvac TF vaccine (15 μg HA per strain per dose) of the GPO seasonal quadrivalent inactivated split virion influenza vaccine in healthy adults aged 18 years and above over 90 days post-injection.
详细描述
This is a double blind randomized study consisting of two phases - Phase I and Phase II.
Phase I of the study A total of 40 healthy participants aged 18 years and above will be enrolled (1:1 ratio, 20 TetraFluvac TF vaccine and 20 Vaxigrip vaccine (Commercially available seasonal quadrivalent split, manufactured by Sanofi Pasteur, Ltd. France)
Phase II of the study A total of 250 healthy participants will be enrolled (4:1 ratio, 200 TetraFluvac TF vaccine and 50 Vaxigrip vaccine (Commercially available seasonal quadrivalent split , manufactured by Sanofi Pasteur, Ltd. France) One dose of the TetraFluvac TF or Commercially available seasonal quadrivalent split vaccine for Southern Hemisphere in 2023 will be given 0.5 ml by intramuscular route.
Total follow-up is 90 days.
The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. After vaccination participants will remain at the clinic for at least 30 minutes to observe for any reactogenicity after immunization.
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
- Double (Participant, Investigator)
盲法说明
Unblinded study staff, including the site pharmacist, will be responsible for preparing study products (in accordance with the randomly determined assignment), and handling all drug accountability procedures. These personnel will not participate in the other aspects of the clinical trial, to help ensure the integrity of the blind at the site. Unblinded staff will retrieve a participant's randomization assignment after being informed by the PI or designee that a participant is eligible for randomization. They will provide the prefilled 0.5 ml dose of study product based on the participant's randomization
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years and above
- •Having Thai ID card or equivalent
- •Able to read and provide written informed consent prior to performance of any study-specific procedure
- •Healthy as defined by no clinically significant acute medical condition, and no chronic medical condition that has not been controlled within 90 days of randomization, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator.
- •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)
排除标准
- •Known history of egg allergy
- •Having had recently influenza infection confirmed as H1N1, H3N2, or Flu B within 3 months preceding enrollment to the trial
- •Vaccination against influenza in the past 6 months preceding enrollment 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 participants 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
- •Employee of any person employed by the Sponsor, the contract research organization (CRO), the PI, study site personnel, or site.
- •Any test for HIV, HBsAg, Hep C antibody shows positive results with clinically significance
研究组 & 干预措施
TetraFluvac TF vaccine
20 participants in phase I study and 200 participants in phase II study will receive a prefilled single dose of 0.5 ml of TetraFluvac TF vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
干预措施: TetraFluvac TF vaccine (Biological)
Vaxigrip vaccine
20 participants in phase I study and 50 participants in phase II study will receive a prefilled single dose of 0.5 ml Vaxigrip vaccine (Commercially available seasonal quadrivalent split, manufactured by Sanofi Pasteur, Ltd. France) will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
干预措施: Vaxigrip vaccine (Biological)
结局指标
主要结局
Number and percentage of Solicited local adverse events post-vaccination.
时间窗: day 7
Frequency of solicited reportable local adverse events (pain or tenderness, limitation arm movement, erythema, swelling or induration)
Number and percentage of Solicited systemic adverse events post-vaccination.
时间窗: day 7
Frequency of solicited reportable systemic adverse events (fever, chill, headache, rhinorrhea, fatigue or malaise, myalgia, arthralgia, rash, nausea or vomiting, diarrhea)
Number and percentage of participants with AESI
时间窗: day 0 up to day 90
Number and percentage of participants with AESI
Number and percentage of participants with unsolicited adverse events
时间窗: day 0 up to day 90
All unsolicited adverse events during 90 days will be analysed in terms of number and percentage and relationship to study vaccine Number and percentage of participants with unsolicited adverse events
Number and percentage of participants with Serious Adverse Event
时间窗: day 0 up to day 90
Number and percentage of participants with Serious Adverse Event
Number and percentage of participants with Medically-Attended Adverse Event
时间窗: day 0 up to day 90
Number and percentage of participants with Medically-Attended Adverse Event
次要结局
- Geometric mean of immune response changed from baseline(day 90)
- Antihemagglutinin antibody titer changed from baseline.(day 90)
研究者
Punnee Pitisuttithum
Professor
Mahidol University