Recruiting

Immunoprophylaxis

Sponsor:

Yale University

Code:

NCT06172660

Conditions

RSV Infection

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Nirsevimab

Study Details

Brief 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?

Conditions

RSV Infection

Study ID

NCT06172660

Start date

Oct 28, 2024

Status verified date

Aug, 2025

Completion date

Dec 30, 2028

Anticipated

Primary completion date

Dec 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

3750 participants

Anticipated

Interventions and Outcome Measures

Arms

ARI Cases

Cases will be defined as infants ≤12 months old who had a clinical encounter for acute respiratory illness (ARI) and tested positive for RSV using polymerase chain reaction (PCR).

Healthy Controls

Healthy controls will be individually matched to enrolled vaccine failures (immunized and RSV+) by date of birth (±1 month), sex, and immunoprophylactic agent received (i.e., maternal vaccine or monoclonal antibody).

ARI Controls

Controls will be individuals with ARI who test negative for RSV and will be frequency matched based on time and clinical setting.

Interventions

Nirsevimab

Immunoprophylaxis against RSV

Primary outcome measure

  • Overall effectiveness of RSV immunoprophylaxis [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Carlos R Oliveira, MD

203-785-5474carlos.oliveira@yale.edu

Locations

Yale Child Health Research Center

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Research Coordinator

203-785-5474

More Information

Sponsor

Yale University

Last update posted

Aug 14, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2025-08-14.