RSV Infection Clinical Trial
Official title:
Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization
A longitudinal observational study based on routinely collected data on hospital and health care use for RSV infections will be undertaken. The Galician public health registries will be used for data collection including baseline information and follow-up data. Historical data will be retrieved for comparison purposes. The study aims to observe and analyze data from all the eligible children in Galicia for nirsevimab treatment. The number of eligible children is expected to be approximately 14,000 per each RSV season.
The purpose of this study is to evaluate the impact of nirsevimab in preventing RSV in healthy infants and high-risk children less than 24 months of age at the start of RSV season in Galicia. The target population to receive nirsevimab is around 14,000 subjects including all healthy newborns during the RSV season, those < 6 months at the start of the season, as well as those < 24 months with comorbidities at the start of the season. Nirsevimab will be administered as part of the immunization program of Galicia and following the implementation plan designed by the Public Health authorities, using the vaccination facilities of the Galician system, i.e., hospitals and primary care centres. Appointments for administration and registration of administered doses will be performed as per usual immunization protocols. The expected coverage with nirsevimab in the target population is expected to be high (>80%). RSV testing is routinely performed in the hospital and emergency department settings. The Galician Regional Surveillance Information System will retrieve all the existing information of the different electronic databases for new RSV cases detected in Galicia, including hospitalization, primary care, drug administration and immunization. RSV case ascertainment and classification will be per- formed by a specialized clinical team according to pre-established definitions. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03698084 -
RESCEU: Defining the Burden of RSV Disease
|
||
| Recruiting |
NCT05550545 -
Infant RSV Infections and Health-related Quality of Life of Families
|
||
| Completed |
NCT05587478 -
A Study of EDP-323 in Healthy Subjects
|
Phase 1 | |
| Suspended |
NCT03909867 -
Emission Patterns of Respiratory Syncytial Virus
|
||
| Recruiting |
NCT06259487 -
Coordinated Vaccination Against RSV and Influenza in Patients With Chronic Heart Failure and Its Impact on Prognosis.
|
N/A | |
| Not yet recruiting |
NCT04144816 -
Predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants
|
||
| Completed |
NCT01090557 -
Exhaled Nitric Oxide in Respiratory Syncytial Virus (RSV) Bronchiolitis: a Pilot Study
|
N/A | |
| Terminated |
NCT01475305 -
Intranasal Challenge of Healthy Adults With Respiratory Syncytial Virus (RSV)
|
Phase 1 | |
| Not yet recruiting |
NCT05928507 -
FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol
|
||
| Completed |
NCT03062917 -
Nasal and Bronchial Absorption Sampling in RSV Bronchiolitis
|
N/A | |
| Completed |
NCT03691623 -
A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model
|
Phase 2 | |
| Completed |
NCT03387137 -
Evaluating the Infectivity, Safety, and Immunogenicity of a Respiratory Syncytial Virus Vaccine (RSV 6120/∆NS2/1030s) in RSV-Seropositive Children and RSV-Seronegative Infants and Children
|
Phase 1 | |
| Completed |
NCT05070975 -
Severity of RSV Infections in Twins
|
||
| Recruiting |
NCT04938830 -
Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
|
Phase 3 | |
| Recruiting |
NCT05568706 -
A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.
|
Phase 2 | |
| Completed |
NCT03755778 -
Drug-Drug Interaction Study Between EDP-938, Itraconazole, Rifampin, and Quinidine in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01483911 -
ALX-0171 Phase I Study, Evaluating Single Ascending Dose and Multiple Dose in Healthy Male Volunteers
|
Phase 1 | |
| Recruiting |
NCT06170242 -
A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model
|
Phase 2 | |
| Completed |
NCT03750383 -
Drug-Drug Interaction Study Between EDP-938, Cyclosporine and Prednisone in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT05118386 -
Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults
|
Phase 1 |