RECRUITING

Real-World Effectiveness of Perinatal RSV Immunoprophylaxis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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?

Official Title

Real-World Effectiveness of Perinatal RSV Immunoprophylaxis

Quick Facts

Study Start:2024-10-01

Study Completion:2028-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06172660

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.

Ages Eligible for Study:Not specified to 12 Months

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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).

Inclusion Criteria

Exclusion 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).

Contacts and Locations

Study Contact

Carlos R Oliveira, MD

CONTACT

203-785-5474

carlos.oliveira@yale.edu

Principal Investigator

Carlos R Oliveira, MD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale Child Health Research Center

New Haven, Connecticut, 06519

United States

Collaborators and Investigators

Sponsor: Yale University

Carlos R Oliveira, MD, PRINCIPAL_INVESTIGATOR, Yale University

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

Study Start Date2024-10-01

Study Completion Date2028-12-30

Study Record Updates

Study Start Date2024-10-01

Study Completion Date2028-12-30

Terms related to this study

Additional Relevant MeSH Terms

RSV Infection