Real-World Effectiveness of Perinatal RSV Immunoprophylaxis

Launched by YALE UNIVERSITY · Dec 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how well vaccines for Respiratory Syncytial Virus (RSV) work in real-life situations. The researchers want to find out important information, such as how effective the vaccines are, how long the protection lasts, how well they work against new strains of the virus, and if their effectiveness changes with different ages. This study is important because it helps ensure that the vaccines are doing their job in protecting infants and young children from RSV infection, which can cause serious respiratory illness.

To participate in this study, children must be 12 months old or younger and currently experiencing symptoms of an acute respiratory infection, such as cough, fever, or difficulty breathing. They need to live in Connecticut, and their parents or guardians must be able to give permission for them to join. Participants will be monitored to gather information on their health and the effectiveness of the vaccines. This research will help improve the understanding of RSV vaccination and its impact on young patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≤ 12 months of age at the time of presentation for evaluation for an acute respiratory infection (ARI).
• • Documentation of an ARI, which is defined as an acute onset (\<10 days) illness that includes: At least two of the following symptoms: fever (measured or subjective), chills, rigors, myalgia, headache, sore throat, nausea or vomiting, diarrhea, fatigue, congestion OR any one of the following: cough, shortness of breath, difficulty breathing, olfactory disorder, taste disorder, confusion, persistent chest pain, pale, gray, hypoxia, clinical or radiographic evidence of pneumonia or respiratory distress syndrome.
• • Residents of Connecticut
• Exclusion Criteria:
• • Illness duration of \>10 days at the time of respiratory specimen collection, measured from the date of the first symptom of the current acute illness.
• • Parents/guardians are not able to provide informed consent
• To be eligible for inclusion in the study as a healthy control, an individual must meet all of the following criteria:
• • Immunized against RSV ≤ 12 months of age
• • Residents of Connecticut
• • Match an enrolled case that was a vaccine failure by date of birth (±1 month), sex, and immunoprophylactic agent received (i.e., maternal vaccine vs mAb).