A Phase III Double Blinded, Randomized, Controlled, Non-inferiority Trial to Evaluate the Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated Split Virion Influenza Vaccine, in Healthy Thai Subjects Aged 65 Years and Above
试验速览
- 阶段
- 3 期
- 入组人数
- 816
- 试验地点
- 1
- 主要终点
- Number and percentage of seroconverted participants at 28 days post vaccination
研究概览
简要总结
The study is aim to evaluate the Immunogenicity with two groups of participants who will received a seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or an active comparator (licensed influenza vaccine).
详细描述
This is a phase III, non-inferiority double-blinded, randomized, controlled trial of immunogenicity with two groups of participants who will received a seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or an active comparator (licensed influenza vaccine).
A total of about 816 healthy Thai male and female adult volunteers ≥ 65 years of age; 408 participants will be randomized to receive the GPO Tri Fluvac and 408 will receive an active comparator (a 1:1 ratio).
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
double blinded
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 65 years old on the day of screening, having Thai ID card or equivalent
- •Able to read and write in Thai and sign written informed consent form
- •Able to attend all scheduled visits and to comply with all trial procedures.
- •Healthy or medically stable, as established by medical history and physical examination. For individuals with medical conditions, symptoms/signs, if present must be stable, under control or unchanged for the past three months. If medication is used to treat the condition, the medication dose must have been stable for at least one month preceding vaccination.
排除标准
- •Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study.
- •Hypersensitivity after previous administration of any vaccine.
- •Having a history of H1N1, H3N2 or FluB infection within 3 months preceding enrollment to the trial
- •Vaccination against influenza in the past 6 months preceding enrollment to the trial
- •Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 28 visit.
- •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. egg proteins, gentamicin or thimerosal)
- •History of Guillain-Barré Syndrome or cerebrovascular events
- •Having acute infection with fever > 38 degree Celsius or noninfectious diseases (within 72 hours) preceding enrollment in the trial
- •Volunteers who have been taking immunoglobulin products or have had a blood transfusion during past 3 months before the beginning of the trial or planned receipt of such products prior to the Day 28 visit.
- •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
- •Study site employees who are involved in the protocol and/or may have direct access to study related area
结局指标
主要结局
Number and percentage of seroconverted participants at 28 days post vaccination
时间窗: 28 days
seroconversion is defined as a serum HI antibody titer meeting the following four fold rising criteria: * Pre-vaccination titer \<1:10 and a post-vaccination measured on Day 28 of ≥1:40; or * Pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination measured on Day 28.
Geometric Mean Titers (GMTs) of serum HI antibodies at baseline (Day 0) and post- vaccination (Day 28).
时间窗: 28 days
Geometric mean titers (GMTs) of serum HI antibodies pre- (Day 0) and post-vaccination (Day 28) for each of the three vaccine antigens. GMTs will be calculated with 95% CI.
次要结局
- Number and percentage of participants with HI response with and without pre-existing HI antibody.(28 days)
- Number and percentage of participants with serious adverse event.(180 days)
- Number and percentage of participants with unsolicited adverse event.(180 days)
- Number and percentage of participants with solicited local and systemic adverse events. post vaccination(30 minutes, Day 1-3 post-vaccination)
研究者
Punnee Pitisuttithum
Professor
Mahidol University