Real-World Effectiveness of Perinatal RSV Immunoprophylaxis

Description

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 Overview

Study Details

Study overview

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?

Real-World Effectiveness of Perinatal RSV Immunoprophylaxis

Real-World Effectiveness of Perinatal RSV Immunoprophylaxis

Condition
RSV Infection
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale Child Health Research Center, New Haven, Connecticut, United States, 06519

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * 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

to 12 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Carlos R Oliveira, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

2028-12-30