Actively Recruiting
Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
Led by Yale University · Updated on 2025-08-14
3750
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 answer with this study are: 1) What is the overall effectiveness of these vaccines? 2) How long does immunity last? 3) How effective are the vaccines against new strains? 3) Does the vaccine's effectiveness vary by age?
CONDITIONS
Official Title
Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 12 months of age or younger at the time of evaluation for an acute respiratory infection (ARI)
- Documentation of an ARI defined as acute onset (less than 10 days) illness with at least two symptoms such as fever, chills, myalgia, headache, sore throat, nausea or vomiting, diarrhea, fatigue, congestion, or at least one symptom like cough, shortness of breath, difficulty breathing, olfactory or taste disorder, confusion, persistent chest pain, pale or gray skin, hypoxia, or clinical/radiographic evidence of pneumonia or respiratory distress syndrome
- Residents of Connecticut
- For healthy controls: immunized against RSV at 12 months of age or younger
- For healthy controls: residents of Connecticut
- For healthy controls: matched to an enrolled vaccine failure case by birth date (±1 month), sex, and immunoprophylactic agent received (maternal vaccine or monoclonal antibody)
You will not qualify if you...
- Illness duration of more than 10 days at the time of respiratory specimen collection, measured from the first symptom of the current acute illness
- Parents or guardians unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yale Child Health Research Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
Research Team
C
Carlos R Oliveira, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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