Tokyo, July 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062124) titled 'Effectiveness of maternal RSVpreF vaccination during Pregnancy against REspiratory syncytial Virus illnEss requiring hospitalizatioN of infanTs in Japan: a multicentre, prospective, test-negative design study' on July 2.

Study Type: Observational

Primary Sponsor: Institute - Saitama Medical University

Condition: Condition - Lower Respiratory Tract Disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To estimate the effectiveness of the RSVpreF vaccine for pregnant women in Japan against lower respiratory tract disease (LRTD) requiring hospitalization in infants under real-world clinical conditions Basic objectives2 - Efficacy

Eligibility: Age-lower limit - Not applicable Age-upper limit - 360 days-old >= Gender - Male and Female Key inclusion criteria - 1) Patients with clinical symptoms and findings consistent with LRTD who are hospitalized at participating medical institutions 2) Infants aged 360 days or younger at the index date (date of admission) 3) Infants born at 37 weeks of gestation or later 4) Patients born on or after April 1, 2026 5) Patients whose mothers were 19 years of age or older at the time of birth 6) Patients for whom written consent has been obtained from the infant's legal representatives and the mother to participate in this study Key exclusion criteria - 1) Patients who have received any RSV prophylactic agent (e.g., palivizumab, nilsebumab, or other RSV vaccines) that has been approved or is currently in clinical trials after birth 2) Patients who have received one or more transfusions or other blood products containing antibodies (e.g., fresh frozen plasma) after birth 3) Patients who had been enrolled in this study within the past 30 days. Patients who had been lastly enrolled in this study before 30 days but tested positive for RSV at the last enrollment will be excluded. 4) Patients whose mother received another approved or investigational RSV vaccine during pregnancy 5) Cases where the responsible investigator determines that participation in this study is inappropriate for medical, social, or psychiatric reasons (including the infants or legal representatives, etc.) Target Size - 939

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 10 Day Date of IRB - 2026 Year 07 Month 02 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2028 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070180

Disclaimer: Curated by HT Syndication.