PACTR202311725768030尚未招募3 期
Phase III, randomized, observer-blind, placebo-controlled, multi-center, multinational study to evaluate the efficacy, immunogenicity, and safety of a Respiratory Syncytial Virus vaccine in infants and toddlers (PEARL)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,350
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
- 1 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •1. Aged 6 months to < 22 months on the day of inclusion
- •2. Participants who are healthy as determined by medical evaluation including medical history.
- •3. Born at full term of pregnancy (= 37 weeks) or born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator, based on the following definition: Medically stable” refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention
- •4. Informed consent form has been signed and dated by the parent(s) or other LAR (and by an independent witness if required by local regulations)
- •5. Participant and parent(s)/LAR are able to attend all scheduled visits and to comply with all study procedures
排除标准
- •1. 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)
- •2. Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances
- •3. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- •4. History of medically diagnosed wheezing
- •5. Any acute febrile illness in the past 48 hours that according to investigator judgment is significant enough to interfere with successful inoculation on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- •6. Probable or confirmed ongoing case of viral respiratory infection (including COVID-19, influenza, rhinovirus, etc.) at the time of enrollment. A prospective participant should not be included in the study until the respiratory infection has resolved.
- •7. Member of a household that contains an immunocompromised individual, including, but not limited to:
- •a person who is HIV infected
- •a person who has received chemotherapy within the 12 months prior to study enrollment
- •a person who has received (within the past 6 months) or is receiving (at the time of enrollment) immunosuppressant agents
- •a person living with a solid organ or bone marrow transplant
研究者
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