Respiratory Syncytial Virus Infections Clinical Trial
Official title:
REspiratory Syncytial Virus Consortium in EUrope (RESCEU) Study: Defining the Burden of Respiratory Syncytial Virus (RSV) Disease.
This observational study will determine the burden of RSV disease in at least 2000 healthy infants over 6 years until November 2026. The study will determine the incidence of acute respiratory tract infection (ARTI) associated with RSV, of medically attended ARTI and RSV related hospitalisation. Mortality (RSV associated and all-cause) through all RSV seasons and the health care costs, resource use and Health Related Quality of Life will also be determined. The study also aims to determine important risk factors for RSV infection (by severity and healthcare utilisation.
Infants will be recruited into one of two cohorts: Passive (around 1800 participants) - Demographic data will be collected at inclusion and a parental questionnaire at one year of age. Infants admitted to a hospital with an acute respiratory tract illness will be followed up to the age of 3 years or 6 years with additional consent. Active (around 200 participants) - Demographic data, parental questionnaire and the following samples will be collected at inclusion; blood, nasopharyngeal swabs, urine and stool. During the infants first RSV season (Oct - May) weekly phone contact will monitor respiratory symptoms. Infants with respiratory symptoms associated with RSV (confirmed by point of care testing) will have further samples of blood, nasopharyngeal swabs, urine and stool collected at the time of infection and 7 weeks later. Infants in the active cohort will be followed up for up to 3 years or 6 years with additional consent. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04090658 -
A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults
|
Phase 1 | |
| Completed |
NCT04231968 -
A Study of AK0529 in Chinese Infants Hospitalized With RSV
|
Phase 3 | |
| Completed |
NCT03227029 -
Evaluating the Infectivity, Safety, and Immunogenicity of Recombinant Live-Attenuated RSV Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants 6 to 24 Months of Age
|
Phase 1 | |
| Completed |
NCT02984280 -
Specific Respiratory Infections as Triggers of Acute Medical Events
|
N/A | |
| Completed |
NCT02873286 -
RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults
|
Phase 2 | |
| Terminated |
NCT02948127 -
Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (RSV LID cp ΔM2-2) in RSV-Seronegative Infants and Children 6 to 24 Months of Age
|
Phase 1 | |
| Withdrawn |
NCT02864628 -
RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults.
|
Phase 1 | |
| Completed |
NCT02040831 -
Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
|
Phase 1 | |
| Completed |
NCT02247726 -
RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women.
|
Phase 2 | |
| Completed |
NCT02237209 -
Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
|
Phase 1 | |
| Completed |
NCT01915394 -
Respiratory Syncytial Virus Infection in Neonatal Intensive Care Units Throughout Turkey: Prospective Multicenter Study (TurkNICU-RSV Trial)
|
N/A | |
| Completed |
NCT01355016 -
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00232635 -
A Study of the Safety and Efficacy of A-60444 in Adults With Respiratory Syncytial Virus (RSV) Infection Following HSCT
|
Phase 2 | |
| Completed |
NCT01155193 -
Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
|
||
| Not yet recruiting |
NCT06083623 -
A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants
|
Phase 2/Phase 3 | |
| Terminated |
NCT02890381 -
Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (RSV LID cp ΔM2-2) in RSV-Seronegative Infants 6 to 24 Months of Age
|
Phase 1 | |
| Active, not recruiting |
NCT03422237 -
Evaluating the Infectivity, Safety, and Immunogenicity of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants and Children 6 to 24 Months of Age
|
Phase 1 | |
| Completed |
NCT03674177 -
A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women
|
Phase 1 | |
| Completed |
NCT01968083 -
Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
|
Phase 1 | |
| Completed |
NCT05590403 -
A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above
|
Phase 3 |