Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
ConditionRSV Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 12
SponsorYale University
About this trial
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
Qualifiers
≤ 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
Disqualifiers
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
Immunized against RSV ≤ 12 months of age
Residents of Connecticut
Trial design
Treatments tested in this trial
- Nirsevimab
Treatment groups
3,750 Participants
are divided into 3 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov