A Phase II/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 18-49 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 945
- 试验地点
- 4
- 主要终点
- Number and Percentage of Seroconverted Participants at 21 Days Post-vaccination
研究概览
简要总结
The study is aim to evaluate the immunogenicity and safety 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 II/III, non-inferiority double-blinded, randomized, controlled trial of immunogenicity and safety 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 945 healthy Thai male and female adult volunteers 18 through 49 years of age; 630 participants will be randomized to receive the GPO Tri Fluvac and 315 will receive an active comparator (a 2:1 ratio) (inclusion of ~7% lost to follow-up).
Safety will be assessed for all participants through Day 90 after vaccination. Immunogenicity will be assessed in serum samples obtained at baseline and 21 days after vaccination in a subset of at least 586 individuals randomized to study vaccine and 293 active comparator vaccine recipients.
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
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-49 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.
- •For female participants:
- •Not breast feeding, non-pregnant (based on negative urine pregnancy test) and no plan to become pregnant up to Day
- •Women who are not surgically sterile (hysterectomy or tubal ligation) or post-menopausal for more than one year must be willing to use effective contraceptive method to prevent pregnancy until Day 60 after vaccination. Effective methods include intrauterine device, hormonal contraceptives (oral, injectable, patch, implant, ring) or double barrier contraceptives (condom or diaphragm with spermicide). Women with credible history of abstinence may be enrolled at the discretion of the investigator
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 Flu B 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 21 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. gentamicin or thimerosal)
- •History of Guillain-Barré Syndrome.
- •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 21 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
结局指标
主要结局
Number and Percentage of Seroconverted Participants at 21 Days Post-vaccination
时间窗: pre-vaccination (Day 0), 21 days post-vaccination
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 titer measured on Day 21 of ≥1:40; or Pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination measured on Day 21. Measured against each of the 3 antigens
Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination
时间窗: pre-vaccination (Day 0), 21 days post-vaccination
Geometric mean titers (GMTs) of serum HI antibodies pre- (Day 0) and post-vaccination (Day 21) for each of the three vaccine antigens. Note that titers below the lowest limit of quantitation (i.e., below the starting dilution of assay reported as "\< 10") will be set to half that limit (i.e., 10/ 2 = 5). If a titer is reported as greater or equal to the upper limit of the assay, it will be set to that limit.
Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination.
时间窗: 30-minutes period,day 1,day 2 and day 3 post-vaccination period
Solicited local and systemic adverse events within 30 minutes of vaccination and over the 3-day period post vaccination. Percentage of participants experiencing each reaction was calculated. Analysis based on Intention to Treat analysis
Number of Participants With Unsolicited Adverse Events.
时间窗: within 90 days post-vaccination
Unsolicited adverse events (AEs) occurring within 90 days post-vaccination. Percentage of participants experiencing each reaction will be calculated.
次要结局
未报告次要终点
研究者
Punnee Pitisuttithum
Prof.
Mahidol University