Real-World Effectiveness of Perinatal RSV Immunoprophylaxis

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06172660
Status
Recruiting
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Conditions

  • RSV Infection

Eligibility Criteria

Sex
ALL
Age
N/A - 12 Months
Healthy Volunteers
Not accepted

Interventions

  • Nirsevimab — DRUG
    Immunoprophylaxis against RSV

Study Details

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?

Key Dates

Start date
Oct 28, 2024
Status verified
Aug 2025
Primary completion
Dec 30, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
3,750 participants (estimated)

Arms

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale Child Health Research CenterNew HavenConnecticut06519
Research Coordinator
203-785-5474

Find similar trials in New Haven, CT

By research site
Yale Child Health Research Center· New Haven, CT

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