A Randomized, Blinded, Comparative Study of Phase II Allantoic Split Inactivated Seasonal Influenza Vaccine in Healthy Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Geometric Mean Fold Increase in HI Antibody Titer
研究概览
简要总结
The study is a single centre, phase II, double-blind, randomized, comparative trial that explored the immunogenicity and safety of single dose a allantoic split inactivated seasonal influenza vaccine and VAXIGRIP vacccine in healthy adults the two age groups (in persons 18 to 60 years of age and older than 60 years).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •volunteers (men and women) aged 18 years and older.
- •Literate and willing to provide written informed consent.
- •A signed informed consent.
排除标准
- •Available in anamnaze volunteer at any allergic reactions.
- •Allergic reactions to chicken proteins, or any preceding vaccination.
- •Acute illness with a fever (37.0 C).
- •Vaccination against influenza in the 2015/2016 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.
- •Any clinically significant abnormal laboratory finding.
- •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
Group #4 (Vaccine VAXIGRIP)
50 volunteers over the age of 60 years, which introduced vaccine VAXIGRIP
干预措施: VAXIGRIP (Biological)
Group #1 (Allantoic Split Inactivated Seasonal flu Vaccine)
100 volunteers aged 18 to 60 years, which introduced the vaccine allantoic split inactivated seasonal influenza
干预措施: Allantoic Split Inactivated Seasonal flu Vaccine (Biological)
Group #2 (Allantoic Split Inactivated Seasonal flu Vaccine)
100 volunteers over the age of 60 years, which introduced the vaccine allantoic split inactivated seasonal influenza
干预措施: Allantoic Split Inactivated Seasonal flu Vaccine (Biological)
Group #3 (Vaccine VAXIGRIP)
50 volunteers aged 18 to 60 years, which introduced vaccine VAXIGRIP
干预措施: VAXIGRIP (Biological)
结局指标
主要结局
Geometric Mean Fold Increase in HI Antibody Titer
时间窗: Change from Baseline HI Antibody Titer at 21 days
Geometric mean fold increase in HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline.
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer
时间窗: Change from Baseline HI Antibody Titer at 21 days
Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer \<10.
Seroprotection Rate of HI Antibody Titer
时间窗: Change from Baseline HI Antibody Titer at 21 days
Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.
次要结局
- Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)(21 Days)
- Serious adverse events (SAEs), including abnormal laboratory findings(21 Days)
- Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs(21 Days)
- Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)(21 Days)