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)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 6,000
- 试验地点
- 10
- 主要终点
- To demonstrate the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV LRTD after
研究概览
简要总结
Infants and young children are at increased risk for respiratory syncytial virus (RSV) infections because of their maturing immune system and lack of prior exposure to RSV. A genetically stable live-attenuated RSV ∆NS2/∆1313/I1314L vaccine (from the US National Institutes of Health) has been shown to be safe and immunogenic in RSV-seronegative children in Phase I studies. Sanofi is conducting Phase I/II clinical studies with a similar RSV ∆NS2/∆1313/I1314L vaccine (referred to as RSVt vaccine) to assess the vaccine safety, immunogenicity, infectivity of the candidate (VAD00001 study) as well as vaccine virus transmissibility to close contacts of study participants (VAD00014 study). Study VAD00004 will be initiated as part of the Phase III development of the RSVt vaccine. The objective of the study is RSVt clinical efficacy, while also further investigating the safety and immunogenicity of the RSVt vaccine in a global context. Vaccine efficacy against lower respiratory tract disease (LRTD) and upper respiratory tract disease (URTD) will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 22.00 Month(s)（—）
- 性别
- All
入选标准
- •Aged 6 months to less than 22 months on the day of inclusion
- •Participants who are healthy as determined by medical evaluation including medical history.
- •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.
- •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).
- •Participant and parent(s)/LAR are able to attend all scheduled visits and to comply with all study procedures.
排除标准
- •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 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
- •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completionc
- •History of medically diagnosed wheezing
- •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.
- •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.
- •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 Potential close contact with other immunocompromised individual within 30 days after each vaccination as per investigator’s discretion
- •Participant’s biological mother’s previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding.
- •Receipt or planned receipt of any of the following vaccines prior to enrollment or after the first study intervention administration: • Any other intranasal live attenuated vaccine within the 28 days prior to and after Dose 1 study administration • Unless given on the day of Dose 1 study administration, any other injectable live attenuated vaccines within the 28 days prior to and after.
- •Concomitant receipt on the day of Dose 1 study administration is allowed.
- •Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV immune globulin) at the time of enrollment.
- •Previous receipt of an RSV monoclonal antibody within 6 months prior to the first study vaccine administration.
- •Receipt of immune globulins, blood or blood-derived products in the past 3 months
- •Receipt of intranasal and intra-ocular medications within 3 days prior to study enrollment
- •Participation at the time of study enrollment or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- •Deprived of freedom in an emergency setting, or hospitalized involuntarily
- •Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
结局指标
主要结局
To demonstrate the clinical efficacy of RSVt vaccine for the prevention of RT-PCR confirmed RSV LRTD after
时间窗: 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1).
2 doses, over RSV Season 1
时间窗: 22 days post-dose 2 up to the start date of first occurrence of LRTD associated with any RT PCR confirmed RSV strain, assessed up to the end of RSV season 1 (ie. up to 12 months post-dose 1).
次要结局
- 1. To demonstrate(the clinical)