Double-Blind, Randomized, Active-Controlled Comparison of the Immunogenicity and Safety of Flublok® Quadrivalent Versus IIV4 in Healthy, Medically Stable Adults 18-49 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,350
- 试验地点
- 18
- 主要终点
- Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
研究概览
简要总结
Randomized, double-blind trial of safety and immunogenicity of Flublok Quadrivalent versus Inactivated Influenza Vaccine (IIV4) in 1350 healthy, medically stable adults 18-49 years of age. Serum samples for Hemagglutinin Inhibition titers will be determined pre- and 28 days post-vaccination. Subjects will be followed for 6 months after vaccination for serious and/or medically-attended adverse events.
详细描述
As the spectrum of influenza vaccines rapidly evolves to quadrivalent formulations with the intention of offering broader protection to include both lineages of influenza B strains, it is appropriate to transition Flublok from a trivalent to a quadrivalent formulation. The demonstration of non-inferior post-vaccination Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) to antigens in the Flublok Quadrivalent formulation compared to those of the matching antigens in a US - approved IIV4 is intended to support licensure of Flublok Quadrivalent for the adult population for which Flublok trivalent is currently approved. The comparison of safety and reactogenicity of Flublok Quadrivalent to that of IIV4 is expected to confirm a similar safety profile.
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 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ambulatory, in good health or medically stable
- •Able to understand and comply with planned study procedures
- •Provide written informed consent
- •Negative urine pregnancy test within 24 hours prior to vaccination (women of child-bearing potential)
排除标准
- •Prior serious or severe reaction to influenza vaccine
- •Known contraindication to either study vaccine
- •Receipt of any other influenza vaccine within 180 days prior to enrollment
- •Plan to receive another licensed influenza or other vaccine during the duration of this study
- •Receipt of any significant new diagnosis, medication (licensed or investigational), or licensed vaccine within 30 days prior to enrollment in this study
- •Underlying disease or therapeutic intervention that might adversely affect the immune response
- •Plans to participate in any investigation involving an investigational product during this study.
- •Pregnant, lactating or planning to become pregnant within 30 days of study vaccine.
- •Any clinical or social circumstance that in the opinion of the investigator could interfere with compliance with study procedures or interfere with the interpretation
结局指标
主要结局
Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
时间窗: Day 28 after final vaccination
Seroconversion is defined as: Either a pre vaccination titer \< 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at Day 28 after the final vaccination.
Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
时间窗: Day 0 and Day 28 after final vaccination
Immunogenicity will be evaluated prior to vaccination and at 28 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) were calculated.
次要结局
- Number of Participants With Systemic and Injection Site Reactogenicity(Days 0-7)
- Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)(Six months post-vaccination)