2023-505762-29-00招募中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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 340
- 试验地点
- 13
- 主要终点
- Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2
研究概览
简要总结
To demonstrate the clinical efficacy of RSVt vaccine for the prevention of reverse transcription polymerase chain reaction (RT PCR) confirmed RSV lower respiratory tract disease (LRTD) after 2 doses, over RSV Season 1
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Aged 6 months to < 22 months on the day of inclusion (means the day of the 6-month birthday to the day before the 22-month birthday)
- •Participants who are healthy as determined by medical evaluation including medical history
- •Born at full term of pregnancy (≥ 37 weeks)
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)
- •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
- •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 completion
- •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.
结局指标
主要结局
Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2
Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2
次要结局
- Occurrence of URTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2
- Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain leading to hospitalization > 21 days post-dose 2
- Occurrence of severe LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2
- Occurrence of urgent care visits, associated with an episode of LRTD over RSV Season 1, associated with any RT-PCR confirmed RSV strain > 21 days post-dose 2
- Occurrence of ARD (during RSV Season 1) associated with any RT-PCR confirmed RSV strain > 21 days post-dose 2
- Occurrence of hospitalizations, associated with an episode of ARD over RSV Season 1, associated with any RT-PCR confirmed RSV strain > 21 days post dose 2
- Occurrence of urgent care visits, associated with an episode of ARD over RSV Season 1, associated with any RT-PCR confirmed RSV strain > 21 days post-dose 2
- Occurrence of LRTD (during RSV Season 1) associated with an RT-PCR confirmed RSV A or B strain > 21 days post-dose 2
- Occurrence of URTD (during RSV Season 1) associated with an RT-PCR confirmed RSV A or B strain > 21 days post-dose 2
- Occurrence of ARD (during RSV Season 1) associated with an RT PCR confirmed RSV A or B strain > 21 days post-dose 2
- Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 1
- Occurrence of URTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 1
- Occurrence of ARD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 1
- Occurrence of LRTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2, in RSV-exposed participants
- Occurrence of URTD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2, by baseline serostatus
- Occurrence of ARD (during RSV Season 1) associated with any RT PCR confirmed RSV strain > 21 days post-dose 2, by baseline serostatus
- Occurrence of LRTD (during RSV Season 2), associated with any RT-PCR confirmed RSV strain
- Occurrence of URTD (during RSV Season 2), associated with any RT-PCR confirmed RSV strain
- Occurrence of ARD (during RSV Season 2), associated with any RT PCR confirmed RSV strain
- Occurrence of LRTD (during RSV Season 2), associated with any RT PCR confirmed RSV strain, by baseline serostatus
- Occurrence of URTD (during RSV Season 2), associated with any RT PCR confirmed RSV strain, by baseline serostatus
- Occurrence of ARD (during RSV Season 2), associated with any RT PCR confirmed RSV strain, by baseline serostatus
- Presence of solicited administration site reactions within 21 days after each vaccination
- Presence of solicited systemic reactions within 21 days after each vaccination
- Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination
- Presence of unsolicited AEs within 28 days after each vaccination
- Presence of medically attended adverse events MAAEs throughout the study
- Presence of serious adverse events (SAEs) throughout the study
- Presence of adverse events of special interest (AESIs) throughout the study
- RSV A serum neutralizing antibody titers at D01
- RSV B serum neutralizing antibody titers at D01
- RSV A serum neutralizing antibody titers at 28 days post-dose 2
- RSV B serum neutralizing antibody titers at 28 days post-dose 2
- RSV serum anti-F Immunoglobulin A (IgA) Electrochemiluminescence (ECL) antibody titers at D01
- RSV serum anti-F IgG ECL antibody titers at D01
- RSV serum anti-F Immunoglobulin A (IgA) ECL antibody titers at 28 days post-dose 2
- RSV serum anti-F IgG ECL antibody titers at 28 days post-dose 2
研究者
Clinical Sciences and Operations
Scientific
Sanofi Pasteur Inc.
研究点 (13)
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