Safety and Efficacy of BARS13 in the Elderly
Respiratory Syncytial Virus InfectionsAdvaccine Clinical Research are developing a vaccine called BARS13 for the active immunisation of infants (aged 6 months to 5 years old) and the elderly (aged 60-80 years old) for the seasonal prevention of Respiratory Syncytial Virus (RSV) infection. A total of 125 volunteers aged 60 - 80 years (inclusive) will be enrolled in this study, and will be divided into 3 groups (or 'cohorts') of 40 people (cohort 1 and 2) and 45 people (cohort 3). The aim of the study is to evaluate the safety and tolerability of BARS13 in this age group.
Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV)...
Respiratory Syncytial Virus InfectionsHuman respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children around the world. This study will evaluate the safety and immune response to a RSV vaccine in three groups of participants: healthy children who have already had an RSV infection (RSV seropositive), healthy infants and children who have not already had an RSV infection (RSV seronegative), and healthy younger infants who have not been screened for prior RSV infection.
A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract...
Respiratory Syncytial Virus InfectionsThe purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), neutralizing antibody and antidrug antibody (ADA) response for TNM001 in infants entering their first RSV season.
Infection With Respiratory Syncytial Virus in Infants
Respiratory Syncytial Virus InfectionsRespiratory Syncytial Virus (RSV)1 moreIRIS (Infection with RespIratory Syncytial Virus) is an observational, multi-center study enrolling infants with severe RSV infection and healthy controls. Inclusion criteria are age below two years and hospitalization due to RSV infection at three German sites. Exclusion criteria are premature birth, congenital or acquired bronchopulmonary or cardiac diseases, and immunodeficiency. Blood and respiratory specimens are collected upon admission, and RSV and other pathogens are analyzed by multiplex polymerase chain reaction (PCR). Further biomaterials including plasma, nasal lining fluid, blood cells, DNA, and RNA specimens are sampled in a dedicated biobank. Detailed information on demographic characteristics and medical history is recorded, as well as comprehensive clinical data including vital signs, medication, and interventions.
Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit
COVID-19 Respiratory InfectionInfluenza A2 moreTo compare the results obtained by analysis of a self-collected anterior nasal (AN) swab as part of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit to a healthcare provider (HCP)-collected AN swab in patients with symptoms of viral respiratory infection consistent with influenza A (Flu A), influenza B (Flu B), respiratory syncytial virus (RSV) and/or SARS-CoV-2 (C-19).
RSV Burden in Outpatient Settings
RSV InfectionChildren5 moreStrengthening outpatient low respiratory tract infection surveillance to document the burden of Respiratory Syncytial Virus (RSV)
Infant RSV Infections and Health-related Quality of Life of Families
RSV InfectionQuality of Life3 moreUntil today, there is only little information available on how severe RSV infection leading to hospitalisation of the infant impacts the quality of life of affected families. For the ResQ Family project, an online questionnaire will be used to survey parents or caregivers of children up to 24 months currently or recently hospitalised (length of hospital stay of at least 12 hours and hospital admission no longer than 4 weeks ago) due to RSV infection. The aim of the ResQ Family project is to find out how infant RSV hospitalisation impacts the quality of life of affected children and their families. The goal is further to provide scientific evidence on the burden of RSV and raise awareness among all relevant stakeholders including healthcare professionals and patient representatives, decision-makers and the general public. The project will run until June 2024. Data collection will take place during the RSV season from fall 2022 to spring 2023 in four European countries: France, Germany, Italy, and Sweden.
A Study to Learn How the Study Medicine Called Sisunatovir is Tolerated and Acts in the Bodies of...
Respiratory Syncytial Virus InfectionThe purpose of the study is to learn about: The activity of sisunotavir in the body over a period. It includes the processes by which sisunotavir is absorbed, distributed in the body, localized in the tissues, and removed from the body. safety and tolerability of sisunatovir (PF-07923568) in Chinese healthy adult participants. This information is being collected to support further clinical development as well as medicine registration in China. This study is seeking for participants who: are male and female participants aged 18 to 65 years of age. are male and female participants who are healthy as seen by medical tests. have body mass index (BMI) of 19 to 27 kg/m2 and a total body weight of more than 50 kilograms (110 pounds). About 12 participants will receive sisunatovir. Four capsules (strength=50 milligrams, 200 milligrams in total) of Sisunatovir will be given on Day 1 on empty stomach. This will be followed by 8 capsules of sisunatovir with 12 hours gap in between four capsules from Days 4 to 7. The participants will have to take 4 capsules of sisunatovir in the morning of 8th day with a meal. The total time of participants will be in the study is about 71 days. This includes the screening visit to the Follow-up contact. In screening visit, participants will be tested to see if they are fit to take part in the study.
A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered...
Respiratory Syncytial Virus InfectionsVirus DiseasesThe purpose of this study is to evaluate pharmacokinetics, safety, tolerability, antiviral activity, and impact on the clinical course of Respiratory Syncytial Virus (RSV) infection after multiple oral doses of JNJ-53718678 at different doses and/or dosing regimens in infants (greater than [>] 1 month to less than or equal to [<=] 24 months of age) who are hospitalized with RSV infection.
Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days...
Respiratory Syncytial Virus InfectionsThe purpose of this study is to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different oral dose levels of JNJ-53718678 in children greater than or equal to 28 days and less than or equal to 3 years of age with respiratory syncytial virus (RSV) disease (hospitalized participants [Cohort 1] or outpatients [Cohort 2]).