Jet Injection for Influenza: A Randomized Controlled Clinical Trial to Demonstrate Non Inferiority of Jet Injection vs. Needle and Syringe for Administration of Trivalent Inactivated Influenza Vaccine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,250
- 试验地点
- 6
- 主要终点
- Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)
研究概览
简要总结
The purpose of this study is to determine if the administration of a seasonal flu vaccine using a PharmaJet's needle-free injection device (STRATIS) is equivalent to needle and syringe administration, as measured by laboratory tests of immune response.
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 the time of enrollment
- •Willing and able to give informed consent after reading the consent form and 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 TIV influenza vaccine, based on University of Colorado Health (UCH) employee health flu screening guidelines.
- •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 immunosuppressive condition including: history of 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, gentamicin 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
STRATIS Needle-Free
Patients assigned to this arm will receive AFLURIA vaccine administered using the Stratis needle-free injection device.
干预措施: AFLURIA vaccine (2012-2013 formulation) (Biological)
STRATIS Needle-Free
Patients assigned to this arm will receive AFLURIA vaccine administered using the Stratis needle-free injection device.
干预措施: Needle-Syringe (Device)
STRATIS Needle-Free
Patients assigned to this arm will receive AFLURIA vaccine administered using the Stratis needle-free injection device.
干预措施: Stratis needle-free injection device (Device)
Needle-Syringe
Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.
干预措施: Stratis needle-free injection device (Device)
Needle-Syringe
Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.
干预措施: Needle-Syringe (Device)
Needle-Syringe
Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.
干预措施: AFLURIA vaccine (2012-2013 formulation) (Biological)
结局指标
主要结局
Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (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 NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.
Anti Influenza Type A/H1N1 Seroconversion
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.
Anti Influenza Type A/H3N2 Seroconversion
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.
Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (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 NS / GMT with PJ Stratis) for A/H1N1 antigen will not exceed 1.5 fold.
Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (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 NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.
Anti Influenza Type B Seroconversion
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
- Number of Subjects With Complaints Within 30 Minutes Following Vaccination(Within 30 minutes post-vaccination)
- Number of Subjects With Vaccine Reactogenicity Events(Day 0, 1, 2, 3, 4, 5, and 6)
- Number of Subjects With Spontaneously Reported Adverse Events(28 days)
- Percentage of Subjects Who Received a PJ Stratis Injection Would Choose to Receive This Type of Injection Again(28 Days)