RecruitingNCT06172660

Real-World Effectiveness of Perinatal RSV Immunoprophylaxis

Sponsor

Yale University

Enrollment

3,750 participants

Start Date

Oct 28, 2024

Study Type

OBSERVATIONAL

Conditions

RSV Infection

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

Max Age: 12 Months

Inclusion Criteria3

≤ 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 Criteria6

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).

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