Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT06172660
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).
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
12 Months
Study:
NCT06172660
Study Brief:
Protocol Section:
NCT06172660