Evaluating the effectiveness of RSV vaccines in real-world settings
Official title: Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
Run by Yale University · NCT06172660 · Data updated 2026-11-12
This study is testing how well RSV vaccines work in the real world for infants who get respiratory illnesses.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 12 Months |
| Sex | All |
| Enrollment | 3750 (estimated) |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Status | Recruiting |
| Started | October 28, 2024 |
| Main results expected | December 30, 2028 |
| Study ends | December 30, 2028 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT06172660 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants aged 12 months or younger who are presenting with acute respiratory infections.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise in evaluating vaccine effectiveness, but this specific approach focusing on perinatal RSV immunoprophylaxis is relatively novel.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Zelicapavir for RSV infection in young children
This study tests whether Zelicapavir can help treat RSV infection in children aged 28 days to 36 months who are showing symptoms.
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Preventing RSV in infants born in France during the 2024–2025 season
This questionnaire will see if infants born in metropolitan France between October 1, 2024 and January 31, 2025 are reached by and receive new RSV prevention measures such as nirsevimab or vaccines.
-
Revaccination with RSV vaccine during subsequent pregnancies
This study is testing if giving a second dose of the RSV vaccine to pregnant women who already had it is safe and effective for them and their babies.
-
Revaccination with SCB-1019T vaccine in older adults
This study is testing a new vaccine called SCB-1019T to see if it can boost immunity in healthy adults aged 60-85 who have already received the AREXVY vaccine.
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Vaccination against RSV in patients with weakened immune systems
This study tests if giving two doses of the RSV vaccine to patients with weakened immune systems helps them better fight off RSV infections compared to the standard one dose given to healthy older adults.
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Measuring how RSV affects young children seen in clinics and hospitals
This project will test adding lab tests for RSV, flu, and COVID-19 for children under 2 who come to clinics or hospitals with ear infections or bronchiolitis to see how often RSV causes their illness.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.