Double-blind, Randomized Clinical Trial With Active Controls to Assess Safety, Immunogenicity and Lot-to-lot Consistency of Inactivated Split-virion Quadrivalent Influenza Vaccine of Butantan Institute
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5,822
- 试验地点
- 12
- 主要终点
- Superiority for influenza B/Yamagata strain
研究概览
简要总结
Studies have shown that a broader spectrum influenza vaccine may help in reducing the influenza burden of disease. Butantan Institute is currently developing a quadrivalent influenza vaccine candidate. This study is will provide safety and immunogenicity data on this quadrivalent influenza vaccine candidate.
The study will be conducted in an open population of healthy participants (3 years old and above) recruited in different clinical sites in Brazil and will be adequately powered to assess safety, immune response (measured by GMT HI antibodies) to each viral strain in the vaccines and lot-to-lot consistency.
详细描述
This is a double blinded, randomized active-control comparator study to assess the safety and immunogenicity of QIV-IB, the Butantan Institute quadrivalent influenza vaccine candidate. As active controls, two trivalent influenza vaccines with different Influenza B strains, one with influenza B/Victoria strain (TIVV-IB) and other with influenza B/Yamagata strain (TIVY-IB).
The study is designed to build a safety database of the quadrivalent influenza vaccine in adults to detect adverse events with a frequency of 1:1000 or higher and safety databases for elderly and pediatric age groups to detect adverse events with frequency of 1:100 or higher.
In terms of immune response, the study aims to demonstrate superiority of HI (Hemagglutinin inhibition) GMT (Geometric Mean Titer) of the QIV-IB for the Influenza B strain that is not present in each trivalent vaccine control. Regarding the Influenza A and B strains common to QIV-IB and both trivalent vaccine controls, the study aims to demonstrate non-inferiority on those strains.
Finally, a lot-to-lot consistency test will be performed in a sub-group of adult participants.
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
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, age 3 years or older at the time of enrollment.
- •Provide written informed consent
- •Agrees to complete all study visits, procedures and contacts
- •Women and adolescents of childbearing age: Negative pregnancy test with understanding (through informed consent process).
排除标准
- •Chronic medical conditions such as psychiatric conditions, diabetes, hypertension or any other conditions that might place the subjects at high risk of adverse events. Study clinicians will use clinical judgment on a case-by-case basis to assess safety risks under this criterion.
- •Clinically significant abnormalities on physical examination.
- •Use of immunosuppressive medications such as systemic corticosteroids or chemotherapeutics, or immunosuppressive illness.
- •Women who are pregnant or planning to become pregnant during the study period plus 3 months beyond the last vaccine dose and currently nursing women.
- •Participation in research involving another investigational product within 30 days before planned date of first vaccination or anytime through the last study safety visit.
- •Clinically significant abnormalities on basic laboratory screening tests.
- •Acute febrile illness (axillar temperature ≥ 37.8°C)
- •Hypersensitivity to egg or chicken proteins or any of the vaccine constituents
- •Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- •Unstable chronic illness (defined as illness requiring hospitalization or a clinically significant change in medication in the previous 12 weeks).
- •Alcohol abuse of alcohol or drug addiction
- •Any vaccination within the previous 4 weeks
- •Seasonal influenza vaccination in the current year
研究组 & 干预措施
TIVV-IB
Inactivated split-virion trivalent Influenza Vaccine containing Influenza B virus - Victoria lineage
干预措施: TIVV-IB (Biological)
QIV-IB
Inactivated split-virion quadrivalent influenza vaccine
干预措施: QIV-IB (Biological)
TIVY-IB
Inactivated split-virion trivalent Influenza Vaccine containing Influenza B virus - Yamagata lineage
干预措施: TIVY-IB (Biological)
QIV-IB Lot A
Inactivated split-virion quadrivalent influenza vaccine - Lot A
干预措施: QIV-IB Lot A (Biological)
QIV-IB Lot B
Inactivated split-virion quadrivalent influenza vaccine - Lot B
干预措施: QIV-IB Lot B (Biological)
QIV-IB Lot C
Inactivated split-virion quadrivalent influenza vaccine - Lot C
干预措施: QIV-IB Lot C (Biological)
结局指标
主要结局
Superiority for influenza B/Yamagata strain
时间窗: 21 days post-vaccination
HI GMT ratio for Influenza B/Yamagata strains between QIV-IB and TIVV-IB
Lot-to-lot consistency for immune response to different lots of QIV-IB
时间窗: 21 days post-vaccination
HI GMT ratios for Influenza among QIV-IB strains towards among of different lots (A, B and C)
Non-inferiority for common influenza strains between QIV-IB, TIVV-IB and TIVY-IB
时间窗: 21 days post-vaccination
HI GMT ratios for Influenza strains between QIV-IB, TIVV-IB and TIVY-IB
Safety through number of Adverse Events of QIV-IB, TIVV-IB, TIVY-IB per age group
时间窗: 42 days post-vaccination
Frequency and intensity of unsolicited adverse reactions and adverse events of special interest
Superiority for influenza B/Victoria strain
时间窗: 21 days post-vaccination
HI GMT ratio for Influenza B/Victoria strains between QIV-IB and TIVY-IB
次要结局
未报告次要终点