NL-OMON53679已完成3 期
A Phase 3, observer-blind, randomized, placebo controlled study to evaluate the non inferiority of the immune response and safety of the RSVPreF3 OA investigational vaccine in adults 50-59 years of age, including adults at increased risk of respiratory syncytial virus lower respiratory tract disease, compared to older adults >=60 years of age. - 219238 - RSV OA=ADJ018
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Participants who, in the opinion of the investigator, can and will comply
- •with the requirements of the protocol
- •A male or female participant 50-59 YOA
- •Female participants migth be of childbearing potential..
- •Female participants of childbearing potential may be enrolled in the study,
- •if the participant:
- •- has practiced adequate contraception from 1 month prior to study intervention
- •administration until study end for this study, and
- •- has a negative pregnancy test on the day of study intervention administration.
- •For participants in the Adults-HA (Healthy Adults) Sub-cohort:
- •Healthy participants as established by medical history and clinical
- •examination before entering into the study.
- •Participants with chronic stable medical conditions with or without specific
- •For participants in the Adults-AIR (At increased Risk) Sub cohort:
- •Chronic pulmonary disease resulting in activity restricting symptoms or use
- •of long term medication:
- •- Chronic obstructive pulmonary disease (COPD); Grade 2-4
- •- Cystic fibrosis
- •- Other chronic respiratory diseases: lung fibrosis, restrictive lung disease,
- •interstitial lung disease, emphysema or bronchiectasis
- •Chronic cardiovascular disease
- •- Chronic heart failure (CHF)
- •- Pre-existing coronary artery disease (CAD not otherwise specified)
- •- Cardiac arrhythmia
- •Diabetes mellitus: types 1 and 2
- •Other diseases at increased risk for RSV-LRTD disease
- •- Chronic kidney disease
- •- Chronic liver disease
- •For participants in Cohort 2 (OA-RSV Group)
- •A male or female participant >=60 YOA
- •Participants with chronic stable medical conditions with or without specific
- •Participants living in the general community or in an assisted-living
- •facility that provides minimal assistance.
排除标准
- •Any confirmed or suspected immunosuppressive or immunodeficient condition
- •History of any reaction or hypersensitivity likely to be exacerbated by any
- •component of the study intervention.
- •Hypersensitivity to latex.
- •Unstable chronic illness.
- •Any history of dementia or any medical condition that moderately or severely
- •impairs cognition.
- •Recurrent or uncontrolled neurological disorders or seizures.
- •Significant underlying illness that in the opinion of the investigator would
- •be expected to prevent completion of the study.
- •Any medical condition that in the judgment of the investigator would make
- •intramuscular injection unsafe.
- •Use of any investigational or non-registered product, or planned use during
- •the study period.
- •Planned or actual administration of a vaccine not foreseen by the study
- •protocol in the period starting 30 days before and ending 30 days after the
- •dose of study intervention administration, with the exception of inactivated
- •and subunit influenza vaccines or COVID-19 vaccines.
- •Previous vaccination with an RSV vaccine, including investigational RSV
- •Chronic administration of immune-modifying drugs and/or administration of
- •long-acting immune modifying treatments or planned administration at any time
- •up to the end of the study.
- •Concurrently participating in another clinical study
- •History of chronic alcohol consumption and/or drug abuse
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive
- •precautions.
研究者
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