EUCTR2020-005566-33-FI进行中（未招募）1 期
Controlled Study of Immunogenicity and Safety of the Investigational vYF Candidate Vaccine in Comparison to Stamaril® in 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
- 690
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
- •-Aged 18 years up to 60 years* on the day of inclusion
- •-A female participant is eligible to participate if she is not pregnant or
- •breastfeeding and one of the following conditions applies:
- •Is of non-childbearing potential. To be considered of non-childbearing
- •potential, a female must be postmenopausal for at least 1 year, or
- •surgically sterile.
- •Is of childbearing potential and agrees to use an effective contraceptive
- •method (1) or abstinence (1) from at least 4 weeks prior to study
- •intervention administration until at least 4 weeks (2) after study
- •intervention administration.
- •*18 to 60 years means from the day of the 18th birthday up to the day
- •before the 60th birthday
- •(1) Not applicable for Finland
- •(2) Except for French participants which have to apply 12 weeks
- •contraception after study intervention administration
- •A female participant of childbearing potential must have a negative
- •highly sensitive pregnancy test (urine or serum as required by local
- •regulation) before any dose of study intervention on Day 1 and the test
- •will be repeated on D29 to confirm the participant is still not pregnant
- •within 28 days of vaccine administration.
- •-Informed consent form has been signed and dated (3)
- •(3) For participants aged less than 21 years in Singapore, an informed
- •consent form has been signed and dated by both the participant and the
- •parent(s) or another legally acceptable representative
- •-Able to attend all scheduled visits and to comply with all study
- •For participants enrolled in Asian countries as part of the additional
- •cohort only: know Chinese origin, defined as having at least one
- •biological parent of Chinese origin, and will be self-reported by the
- •participant
- •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 690
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Participants are excluded from the study if any of the following criteria
- •. Participation at the time of study enrollment (or in the 4 weeks
- •preceding the study vaccination) or planned participation during the first
- •2 years of the 5-year follow-up in another clinical study investigating a
- •vaccine, drug, medical device, or medical procedure. Enrollment in
- •another study after the first 2 years is permitted, assuming that it does
- •not exclude participation in this study.
- •. Receipt of any vaccine in the 4 weeks preceding the study vaccination
- •or planned receipt of any vaccine in the 4 weeks following the study
- •vaccination (prior to visit 4), except for influenza vaccination, which may
- •be received at least 2 weeks before study vaccines (4). This exception
- •includes all influenza vaccines including monovalent pandemic influenza
- •. Previous vaccination against a FV disease at any time including YF with
- •either the study vaccine or another vaccine.
- •. Receipt of immune globulins, blood, or blood-derived products in the
- •past 6 months.
- •. Known or suspected congenital or acquired immunodeficiency; or
- •receipt of immunosuppressive therapy, such as anti-cancer
- •chemotherapy, or radiation therapy, within the preceding 6 months; or
- •long-term systemic corticosteroid therapy (prednisone or equivalent for
- •more than 2 consecutive weeks within the past 3 months).
- •. Known history of any FV infection.
- •. Known systemic hypersensitivity to any of the vaccine components,
- •eggs, or history of a life-threatening reaction to the vaccines used in the
- •study or to a vaccine containing any of the same substances.
- •. Known history or laboratory evidence of HIV infection (5).
- •. Known history or laboratory evidence of hepatitis B or hepatitis C
- •infection (6).
- •. Personal or family history of thymic pathology (thymoma, thymectomy,
- •or myasthenia).
- •. Deprived of freedom by an administrative or court order, or in an
- •emergency setting, or hospitalized involuntarily.
- •. Alcohol, prescription drug, or substance abuse that, in the opinion of
- •the Investigator, might interfere with the study conduct or completion.
- •. Chronic illness (7) that, in the opinion of the Investigator, is at a stage
- •where it might interfere with trial conduct or completion, including
- •malignancy, such as leukemia, or lymphoma.
- •. Moderate or severe acute illness/infection (according to Investigator
- •judgment) on the day of vaccination or febrile illness (temperature =
- •100.4°F or 38°C). A prospective participant should not be included in the
- •study until the condition has resolved or the febrile event has subsided.
- •. Administration of any anti-viral within 2 months preceding the
- •vaccination and planned administration up to the 6 weeks following the
- •vaccination.
- •. Identified as an Investigator or employee of the Investigator or study
- •center with direct involvement in the proposed study, or identified as an
- •immediate family member (ie, parent, spouse, natural or adopted child)
- •of the Investigator or employee with direct involvement in the proposed
- •. Planned travel in a YF endemic country within 6 months of
- •investigational or control vaccine administration.
- 另有 5 项未显示
研究者
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