Inactivated Influenza Via Jet Injection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 985
- 试验地点
- 9
- 主要终点
- Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)
研究概览
简要总结
The purpose of this study is to determine if the administration of flu vaccine using Needle-Free is equivalent to Needle and Syringe administration as measured by laboratory tests of immune response.
详细描述
Primary:
To evaluate the non-inferiority of flu vaccine administered by needle-free intramuscular (IM) injection versus needle and syringe IM injection as determined with serum hemagglutination inhibition (HAI) reciprocal titers in healthy adults between 18-64 years.
Secondary:
To compare tolerability and safety of the vaccine in the same population based on specifically solicited local and systemic reactions occurring through 7 days post-immunization and adverse events spontaneously reported through approximately 28 days post immunization.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged ≥ 18 and ≤ 64 years of age at time of enrollment
- •Willing and able to give informed consent after reading the consent form and given adequate opportunity to discuss the study with the investigator or qualified designee
- •Willing and able to adhere to all protocol required study procedures and to attend scheduled visits
- •Able to receive the trivalent influenza vaccine (TIV) or quadrivalent influenza vaccine (QIV) based on PI judgment
- •Stable health status with no exclusionary medical or neuropsychiatric conditions as determined during the screening evaluation and based on the clinical judgment of the investigator or qualified designee
- •Access to a consistent means of telephone contact
排除标准
- •Presence of any febrile illness (oral temperature >38 °C) on the day of immunization. Such subjects will be reevaluated for enrollment after resolution of illness
- •Presence of significant acute or chronic uncontrolled medical or neuropsychiatric illness and /or presence of any significant condition that may prohibit inclusion as determined by the investigator or his qualified designee. Uncontrolled is defined as: requiring institution of a new treatment within 1 month prior to study enrollment or change in medication dosage in the month prior to study enrollment
- •Any known immunosuppressive condition including: history of human immunodeficiency virus (HIV) infection, cancer or cancer treatment within 3 years of study enrollment, systemic glucocorticoids (in a dose ≥10 mg prednisone daily or equivalent for more than 7 consecutive days or for 10 or more days in total) within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 3 months of study enrollment. Any significant disorder of coagulation that would increase the risk of intramuscular injections or treatment with Coumadin derivatives or heparin
- •Known or suspected to be allergic to eggs, chicken protein, neomycin, polymyxin or influenza vaccine
- •History of severe or previous serious adverse reaction after an influenza vaccination
- •Receipt of any immunoglobulin and/or blood products within 3 months of immunization or planned administration of any of these products during the study period
- •Prior history of any demyelinating disease including Guillain-Barre syndrome.
- •Presence of an active neurological disorder
- •History of significant alcohol or drug abuse within one year prior to study enrollment
- •Influenza vaccination or laboratory confirmed influenza infection within the previous six months before study vaccination or planned influenza vaccination during the study period
- •Planned administration of any non-influenza vaccines 30 days prior to the study or during the study period
- •Pregnant or plans to become pregnant during the study period
- •Currently enrolled in another vaccine or drug study
研究组 & 干预措施
Needle and Syringe
Subjects will receive a single 0.5mL injection of inactivated Influenza Vaccine in the deltoid region on Day 0.
干预措施: Influenza Vaccine (Biological)
Needle- Free
Subjects will receive a single 0.5mL injection of inactivated influenza vaccine in the deltoid region on Day 0.
干预措施: Influenza Vaccine (Biological)
结局指标
主要结局
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)
时间窗: 28 Days
The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio (GMT with Needle-Free / GMT with Needle and Syringe) antigen will not exceed 1.5 fold.
The Number of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titer.
时间窗: 28 Days
Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (\<1:10), attainment of a post-immunization titer of ≥1:40.
次要结局
- Percentage of Subjects With Solicited Local or Systemic Adverse Events(7 Days)
- Percentage of Subjects With Immediate Complaints(Day 0)
- Percentage of Subjects With Spontaneously Reported Adverse Events(28 days)