NL-OMON52252已完成3 期
A phase 3 study to evaluate the efficacy, immunogenicity, and safety of Respiratory Syncytial Virus (RSV) prefusion F subunit vaccine in adults - C3671013 (9002/0849)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 5,000
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
- •1. Participants who are willing and able to comply with all scheduled visits,
- •vaccination plan, laboratory tests, lifestyle considerations, frequent symptom
- •assessment by mobile device application, and other study procedures, including
- •collection of nasal swabs by themselves and by study staff when indicated.
- •2. Healthy participants who are determined by medical history, physical
- •examination (if required), and clinical judgment of the investigator to be
- •eligible for inclusion in the study.
- •Note: Healthy participants with preexisting stable disease, defined as disease
- •not requiring significant change in therapy or hospitalization for worsening
- •disease during the 6 weeks before enrollment, can be included. Specific
- •criteria for participants with known stable infection with HIV, HCV, or HBV can
- •be found in Section 10.8.
- •3. Adults who are ambulatory and live in the community, or in assisted-living
- •or long-term care residential facilities that provide minimal assistance, such
- •that the participant is primarily responsible for self-care and activities of
- •daily living.
- •4. Capable of giving signed informed consent as described in Section 10.1,
- •which includes compliance with the requirements and restrictions listed in the
- •ICD and in this protocol.
- •5. Male or female participants >=60 years of age.
- •* Male participants able to father children must agree to use a highly
- •effective method of contraception from the time of informed consent through at
- •least 28 days after study intervention administration (see Section 10.3.1).
- •* Female participants must not be of childbearing potential (see Section
- •10.3.3).
排除标准
- •1. Bleeding diathesis or condition associated with prolonged bleeding that
- •would, in the opinion of the investigator, contraindicate intramuscular
- •2. History of severe adverse reaction associated with a vaccine and/or severe
- •allergic reaction (eg, anaphylaxis) to any component of the study
- •intervention(s) or any related vaccine.
- •3. Serious chronic disorder including metastatic malignancy, end-stage renal
- •disease with or without dialysis, clinically unstable cardiac disease, or any
- •other disorder that, in the investigator*s opinion, excludes the participant
- •from participating in the study.
- •4. Immunocompromised individuals with known or suspected immunodeficiency, as
- •determined by history and/or laboratory/physical examination.
- •5. Other medical or psychiatric condition including recent (within the past
- •year) or active suicidal ideation/behavior or laboratory abnormality that may
- •increase the risk of study participation or, in the investigator*s judgment,
- •make the participant inappropriate for the study.
- •6. Participation in other studies involving study intervention within 28 days
- •prior to consent and/or through and including the 6-month follow-up visit
- •(Visit 3). Note: This criterion does not apply to participants who are
- •participating in a follow-up period for another study involving a study
- •intervention that is an investigational drug or vaccine, if receipt of the last
- •dose was at least 12 months prior to consenting for this study and there is no
- •further dosing anticipated from the previous study during the participant's
- •participation in this study.
- •7. Individuals who receive chronic systemic treatment with immunosuppressive
- •therapy, including cytotoxic agents, monoclonal antibodies, systemic
- •corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from
- •60 days before study intervention administration or planned receipt throughout
- •the study. If systemic corticosteroids have been administered short term (<14
- •days) for treatment of an acute illness, participants should not be enrolled in
- •the study until corticosteroid therapy has been discontinued for at least 28
- •days before study intervention administration. Inhaled/nebulized,
- •intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are
- •permitted. Note: Participants with COPD or asthma can be enrolled if chronic
- •corticosteroids do not exceed a dose equivalent to 10 mg/day of prednisone.
- •8. Receipt of blood/plasma products or immunoglobulin within 60 days before
- •study intervention administration.
- •9. Previous vaccination with any licensed or investigational RSV vaccine or
- •planned receipt during study participation.
- •10. Investigator site staff or Pfizer employees directly involved in the
- •conduct of the study, site staff otherwise supervised by the investigator, and
- •their respective family members.
研究者
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