EUCTR2015-000728-27-CZ进行中（未招募）1 期
A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults = 65 Years of Age - Phase III Efficacy Study of aQIV in Elderly Adults
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6,790
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
入选标准
- •1.Males and females = 65 years old who are healthy or have co-morbidities
- •2.Individuals who or whose legal guardian have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- •3. Ability to attend all scheduled visits and to comply with study procedures including follow-up (and responding to messages and telephone contact).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10692
排除标准
- •1.Receipt of diphtheria or tetanus toxoid or pertussis (acellular or whole cell) vaccines within the previous 5 years.
- •2.History of behavioral or cognitive impairment or psychiatric condition that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
- •3.History of any medical condition considered an adverse event of special interest, see Section 7.1.4.1, Adverse Events of Special Interest.
- •4.Progressive or severe neurological disorder, seizure disorder, or history of Guillain-Barré syndrome.
- •5.Hypersensitivity, including allergy, to any component of vaccines see Table 6.1-1 and Table 6.1-2 , medicinal products or medical equipment whose use is foreseen in this study.
- •6.Encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous pertussis antigen-containing vaccine.
- •7.Clinical conditions representing a contraindication to intramuscular vaccination and blood draws, including bleeding diathesis, or any other condition that may be associated with prolonged bleeding.
- •8.Abnormal function of the immune system resulting from:
- •a.Clinical conditions.
- •b.Systemic administration of corticosteroids (PO/IV/IM) at a dose equivalent to 20 mg of prednisone for more than 14 consecutive days within 90 days prior to informed consent.
- •c.Administration of antineoplastic and immunomodulating agents (e.g. TNF a antagonists or anti-B cell antibodies) or radiotherapy within 1 year prior to informed consent.
- •9.Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
- •10.Receipt of an investigational or non-registered medicinal product within 30 days prior to informed consent or before completion of the safety follow-up period in another study and who are unwilling to refuse participation in another clinical study at any time during the conduct of this study (note: concomitant participation in an observational study not involving drugs, vaccines, or medical devices, is acceptable).
- •11.Study personnel or immediate family members (brother, sister, child, parent), the spouse of study personnel or individuals who are financially or emotionally dependent on study staff.
- •12.Receipt of any influenza vaccine within 6 months prior to enrolment in this study or who plan to receive influenza vaccine while participating in the study.
- •13.Receipt of any inactivated vaccine 14 days or live-attenuated vaccine 28 days prior to enrolment in this study or who are planning to receive any vaccine within 28 days from study vaccination.
- •14.Fever at the time of screening, defined as oral temperature =38.0 degrees Celsius (= 100.4° F). Enrolment could be considered if fever is absent for 72 hours.
- •15.Signs or symptoms of acute respiratory tract infection at the time of screening. Enrolment could be deferred if signs and symptoms are absent for 72 hours.
- •16.Residence in a chronic care facility (e.g. nursing home).
- •17.Participation in this trial in a prior season, if applicable.
- •18.Fatal prognosis of an underlying medical condition (<12 months life expectancy).
研究者
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