EUCTR2015-002758-11-LT进行中（未招募）1 期
A Phase 2b Randomized, Double-blind Study to Evaluate the Efficacy of MEDI7510 for the Prevention of Acute Respiratory Syncytial Virus-associated Respiratory Illness in Older Adults - A Study to Evaluate the Efficacy of MEDI7510 in Older Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age = 60 years at the time of screening.
- •2. Written informed consent and any locally required authorization (eg, Health Insurance
- •Portability and Accountability Act) obtained from the subject prior to performing any
- •protocol-related procedures, including screening evaluations.
- •3. Medically stable such that, according to the judgment of the investigator, hospitalization
- •within the study period is not anticipated and the subject appears likely to be able to
- •remain in follow-up through the end of protocol-specified follow-up.
- •4. Subject able to visit the clinic for study-specified visits and subject also available by
- •5. Subject able to understand and comply with the requirements of the protocol.
- •6. Subject able to complete study follow-up period in Season 1 and, according to investigator judgment, reasonably likely to complete the study follow-up period in Season 2 if assigned.
- •1. Subject received MEDI7510 + IIV in the Northern Hemisphere in Season 1.
- •2. Subject able to visit the clinic for study-specified visits and subject also available by
- •3. Subject able to understand and comply with the requirements of the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 570
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1330
排除标准
- •1. History of allergy to any component of the vaccine.
- •2. Receipt of seasonal influenza vaccine within 6 months prior to Season 1 dosing.
- •3. History of allergy to or intolerance of IIV.
- •4. Pregnancy or potential to become pregnant during the study.
- •5. History of Guillain-Barré syndrome.
- •6. Cognitive disorder such that informed consent cannot be obtained directly from the
- •7. Previous vaccination against RSV.
- •8. History of allergy to eggs in adulthood.
- •9. History of or current autoimmune disorder, with the exception of stable, treated hypothyroidism caused by autoimmune thyroiditis.
- •10. Immunosuppression caused by disease, including human immunodeficiency virus
- •infection (assessed by history), or medications. Any receipt of oral or intravenous
- •glucocorticoid therapy within 30 days prior to enrollment or planned dosing within the
- •follow-up period would disqualify. Topical, intranasal, inhaled, or intra-articular
- •corticosteroids do not disqualify. Expected need for immunosuppressive medications
- •during the follow-up period would disqualify.
- •11. History of cancer within preceding 5 years other than treated non-melanoma skin cancer,
- •locally-treated cervical cancer or in situ carcinoma of the breast.
- •12. Significant infection or other acute illness, including fever = 100°F (= 37.8°C) on the day
- •prior to or day of randomization.
- •13. Receipt of any non-study vaccine within 28 days prior to study dosing or expected receipt
- •of non-study vaccine prior to the Day 29 visit in Season 1.
- •14. Receipt of any investigational product in the 90 days prior to randomization or expected
- •receipt of investigational product during the period of study follow-up.
- •15. Receipt of immunoglobulins or blood products within 4 months of study dosing
- •(120 days) or expected receipt of immunoglobulins or blood products during the period
- •of study follow-up.
- •16. Current bleeding or clotting disorder including use of anticoagulants other than drugs
- •with anti-platelet activity (such as nonsteroidal anti-inflammatory drugs, clopidogrel,
- •ticagrelor or aspirin).
- •17. Any condition that, in the opinion of the investigator, would interfere with evaluation of
- •the investigational product or interpretation of subject safety or study results.
- •18. History of alcohol or drug abuse or psychiatric disorder that, in the opinion of the
- •investigator, would affect the subject’s safety or compliance with study.
- •1. Related Grade 3 or 4 AE including Grade 3 or 4 local reaction to either MEDI7510 or
- •IIV, any AESI for an adjuvanted vaccine, or any related SAE.
研究者
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