NCT06172660 Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
| NCT ID | NCT06172660 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | RSV Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,750 participants |
| Start Date | 2024-10-28 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,750 participants in total. It began in 2024-10-28 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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?
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).
Contact & Investigator
Carlos R Oliveira, MD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT06172660 clinical trial?
This trial is open to participants of all sexes, up to 12 Months, studying RSV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06172660 currently recruiting?
Yes, NCT06172660 is actively recruiting participants. Contact the research team at carlos.oliveira@yale.edu for enrollment information.
Where is the NCT06172660 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT06172660 clinical trial?
NCT06172660 is sponsored by Yale University. The principal investigator is Carlos R Oliveira, MD at Yale University. The trial plans to enroll 3,750 participants.