Evaluating the effectiveness of RSV vaccines in real-world settings
Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
This study is testing how well RSV vaccines work in the real world for infants who get respiratory illnesses.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3750 (estimated) |
| Ages | N/A to 12 Months |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06172660 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the real-world effectiveness of perinatal RSV immunoprophylaxis by conducting a large-scale case-control analysis. Patients presenting with acute respiratory illness will be enrolled, and RSV infections will be confirmed using molecular assays. Data will be collected from various sources, including health records and immunization registries, to estimate vaccine effectiveness based on time since immunization, disease severity, and demographic factors. Additionally, the study will analyze the genetic diversity of RSV viruses and investigate immune responses in infants during RSV infection.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 12 months or younger who are presenting with acute respiratory infections.
Not a fit: Patients with respiratory illness lasting more than 10 days or those whose guardians cannot provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of RSV vaccines, potentially improving immunization strategies and patient outcomes.
How similar studies have performed: Other studies have shown promise in evaluating vaccine effectiveness, but this specific approach focusing on perinatal RSV immunoprophylaxis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
New Haven, Connecticut
- Yale Child Health Research Center — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Carlos R Oliveira, MD — Yale University
- Study coordinator: Carlos R Oliveira, MD
- Email: carlos.oliveira@yale.edu
- Phone: 203-785-5474
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.