A Phase 3, an Open Clinical Trials to Evaluate Effectiveness, Safety and Immunogenicity of a Allantoic Split Inactivated Seasonal Influenza Vaccine in Healthy Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Preventive efficacy - Incidence of influenza among vaccinated and unvaccinated volunteers
研究概览
简要总结
The study is Multicenter, phase 3, Open-Label trial that explored the preventive effectiveness, safety and immunogenicity of single dose a allantoic split inactivated seasonal influenza vaccine in healthy adults.
详细描述
The study will include 2000 volunteers, 1,000 of whom will be vaccinated intramuscularly with a single dose of allantoic split inactivated seasonal influenza vaccine.
All participants will be observed for 6 months to evaluate the effectiveness of the vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Healthy volunteers of both sexes aged from 18 years.
- •Literate and willing to provide written informed consent.
- •A signed informed consent.
- •Able to attend all scheduled visits and to comply with all trial procedures.
排除标准
- •Allergic reactions to chicken proteins, or any preceding vaccination.
- •Acute illness with a fever (37.0 C).
- •Vaccination against influenza in the 2017/2018 season.
- •Current or recent (within two weeks of enrollment) acute respiratory illness with or without fever.
- •Hypersensitivity after previous administration of any vaccine.
- •History of chronic alcohol abuse and/or illegal drug use.
- •A positive pregnancy test for all women of childbearing potential.
- •Administration of immunosuppressive drugs or other immune modifying drugs within 4 weeks prior to study enrollment.
- •Acute or chronic clinically significant pulmonary disease, cardiovascular disease, gastrointestinal disease, liver disease, neurological illness, liver disease, blood disease, skin disorder, endocrine disorder, neurological illness and psychiatric disorder as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives.
- •History of leukemia or any other blood or solid organ cancer.
- •Receipt of antivirals, antibiotics, immunoglobulins or other blood products within 4 weeks prior to study enrollment or planned receipt of such products during the period of subject participation in the study.
- •Participation in another clinical trial within the previous three months or planned enrollment in such a trial during the period of this study.
- •Subjects who are, in the opinion of the investigator, at significantly increased risk of non-cooperation with requirements of the study protocol.
研究组 & 干预措施
Allantoic split inactivated seasonal influenza vaccine
A allantoic split inactivated seasonal influenza vaccine has been prepared on eggs and is made from inactivated parts of the following influenza virus strains: NYMC X-275 (A/PR/8/34 (M, PB2, PA, NS, NP genes) и A/Michigan/45/2015 (PB1, HA, NA genes)), NYMC X-263В (A/PR/8/34 (PB1, PB2, PA, NS, NP, М genes) и A/Hong Kong/4801/2014 (HA, NA genes)), NYMC BX-35 (B/Lee/40 (NP gene), B/Panama/45/90 (PB2, М genes) и B/Brisbane/60/2008 (HA, NA PB1, PA, NS genes)).
干预措施: influenza vaccine (Biological)
结局指标
主要结局
Preventive efficacy - Incidence of influenza among vaccinated and unvaccinated volunteers
时间窗: 180 days
An assessment of the incidence of influenza among vaccinated and unvaccinated volunteers will be conducted within 180 days of observation (PCR diagnostics for the detection of influenza viruses).
次要结局
- Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)(21 days)
- Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)(Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose)
- Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs(Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days)
- Serious adverse events (SAEs), including abnormal laboratory findings(up to 24 weeks)
- Geometric Mean Fold Increase in HI Antibody Titer(Change from Baseline HI Antibody Titer at 21, 90 and 180 days)
- Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer(Change from Baseline HI Antibody Titer at 21, 90 and 180 days)
- Seroprotection Rate of HI Antibody Titer(Change from Baseline HI Antibody Titer at 21, 90 and 180 days)