NOT_YET_RECRUITING
Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
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:
🦠 RSV Infection
🗓️ Study Start (Actual) 1 July 2024
🗓️ Primary Completion (Estimated) 30 December 2028
✅ Study Completion (Estimated) 30 December 2028
👥 Enrollment (Estimated) 3750
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 New Haven, Connecticut, United States

📋 Eligibility Criteria

Description

    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).
Ages Eligible for Study: N/A to 12 Months (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 December 2023
  • First Submitted that Met QC Criteria 6 December 2023
  • First Posted 15 December 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 April 2024
  • Last Update Posted 24 April 2024
  • Last Verified April 2024