CTRI/2023/08/056078尚未招募不适用
A Multi-center, Multi-national, Prospective Surveillance Study of RespiratorySyncytial Virus Disease in Infants & Toddlers 6 to less than 22 Months of Age
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- 1. To assess the baseline RSV
研究概览
简要总结
The objective of this study is to prepare for the global Phase III vaccine efficacy VAD00004 study. VAD00019 study will test the processes and case definitions planned for the VAD00004 study. The purpose is to generate seroprevalence data to estimate the proportion of infants and toddlers who had been previously exposed to RSV or RSV antibodies (monoclonal or maternal), to test the RSV illness definitions, and to evaluate the incidence of lower respiratory tract disease (LRTD) and ARD cases associated with reverse transcription polymerase chain reaction (RTPCR) confirmed RSV in the targeted population (incidence over
the study duration of approximately one RSV season), and the proportion of LRTD among ARD cases .
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6.00 Month(s) 至 22.00 Month(s)（—）
- 性别
- All
入选标准
- •Participants are eligible for the study only if all of the following criteria are met: Age I01: Aged 6 months to < 22 months on the day of inclusion Type of participant and disease characteristics I02: Participants who are healthy as determined by medical evaluation including medical history I03: 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 are enrolled in the study Informed Consent I04: 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) OTHER INCLUSIONS I05: Participant and parent/LAR are able to attend all scheduled visits and to comply with all study procedures.
排除标准
- •Participants are not eligible for the study if any of the following criteria are met: Medical conditions E01: 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) E02: Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion.
- •E03: 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 E04: Member of a household that contains an immunocompromised individual, including, but not limited to: • a person who is human immunodeficiency virus (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 Prior/concomitant therapy E05: Participant’s mother previous receipt or planned administration of an investigational RSV vaccine during pregnancy and/or breastfeeding E06: Receipt or planned receipt of any of the following vaccines: • Any intranasal live attenuated vaccine within the 28 days prior to enrollment • Any injectable live attenuated vaccine within the 28 days prior to and after enrollment E07: Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV immune globulin or RSV monoclonal antibody) less than 6 months before enrollment E08: Receipt of immune globulins, blood or blood-derived products in the past 3 months Prior/concurrent clinical study experience E09: 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 Other exclusions E10: Deprived of freedom in an emergency setting, or hospitalized involuntarily E11: Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study If the participant has a primary physician who is not the investigator, the site should contact this physician with the participant’s parents / LAR’s consent to inform this physician of the participant’s participation in the study.
- •In addition, the site should ask this primary physician to verify exclusion criteria relating to previous therapies, such as receipt of blood products or previous vaccines.
结局指标
主要结局
1. To assess the baseline RSV
时间窗: At Day 01
2. To assess the incidence during the study of
时间窗: At Day 01
RT PCR confirmed RSV ARD & LRTD, overall and by country
时间窗: At Day 01
seroprevalence, overall & by country
时间窗: At Day 01
次要结局
- 1. To assess the baseline RSV(seroprevalence for each age group (overall & by country))
研究者
研究点 (2)
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