Status:
RECRUITING
Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
RSV Infection
Eligibility:
All Genders
Up to 12 years
Brief Summary
The purpose of this study is to continue evaluating how well the RSV vaccines work as they are currently being used in routine clinical practice. Some of the questions that the investigators hope to a...
Detailed Description
This will be a large-scale case-control study aiming to evaluate the effectiveness of perinatal RSV immunoprophylaxis. Cases and controls will be identified using active surveillance in both inpatient...
Eligibility Criteria
Inclusion
- ≤ 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
- 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).
Key Trial Info
Start Date :
October 28 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
3750 Patients enrolled
Trial Details
Trial ID
NCT06172660
Start Date
October 28 2024
End Date
December 30 2028
Last Update
August 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale Child Health Research Center
New Haven, Connecticut, United States, 06519