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Showing 1-20 of 73 trials
NCT06042049
The purpose of this study is to measure the safety, PK, occurrence of ADA to nirsevimab, and anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term infants aged ≤12 months. Study details include * The study duration is approximately 21 months with a 2-month enrollment period. * Study intervention is 2 doses administered 5- 6 months apart. * The study has 5 or 6 site visits and several telephone contacts with a 2 or 4 week interval.
NCT04732871
The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 5 years following a single dose vaccination of GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given according to different revaccination schedules.
NCT05705440
The purpose of this follow-up study was to describe the safety in subsequent pregnancies in participants who were previously administered the RSVPreF3 maternal vaccine or control during any prior RSV MAT study. The study participants enrolled in this follow-up study received RSVPreF3 maternal vaccination (any dose) or controls during the following prior RSV MAT studies: RSV MAT-001 (NCT03674177), RSV MAT-004 (NCT04126213), RSV MAT-010 (NCT05045144), RSV MAT-011 (NCT04138056), RSV MAT-009 (NCT04605159), RSV MAT-012 (NCT04980391) and RSV MAT-039 (NCT05169905). No intervention was administered in this study. The exposure was the intervention (either RSVPreF3 vaccine or control) received by the study participants in the abovementioned prior RSV MAT studies.
NCT06534892
The purpose of this study is: * To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose, * To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine, * To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information.
NCT07220109
The study will evaluate the immune response of the RSVPreF3 OA investigational vaccine in Chinese adults 18 to 59 years of age (YOA) who are at increased risk of respiratory syncytial virus (RSV) disease, in comparison with the immune response generated in older adults 60 YOA and above from the 219815 (RSV OA=ADJ-021; NCT06551181) study following a single dose of the RSVPreF3 OA vaccine. In addition, the safety and reactogenicity of the vaccine will also be assessed.
NCT07092865
This study evaluates persistence of the immune response of the adjuvanted RSV vaccine and the safety and immunogenicity following revaccination in adults 18 years of age and above who received lung or kidney transplant.
NCT07417657
Respiratory syncytial virus (RSV) is a leading cause of severe lower respiratory tract infection in young children, and a substantial proportion of severe cases occur in previously healthy infants. The gut-lung axis suggests that gut microbiome composition may modulate respiratory immune responses. This prospective observational study in Vietnam will compare gut microbiome profiles and systemic immune cytokine responses between infants with severe RSV infection and those with mild RSV infection, aiming to identify microbiome-immune signatures associated with disease severity.
NCT04767373
The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants. It is hypothesized that clesrovimab will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from Days 1 through 150 postdose compared to placebo.
NCT06546800
This post-marketing study is a multicenter cohort study in individuals aged 60 years or older vaccinated with Abrysvo (RSV vaccine）designed to confirm the safety in individuals aged 60 years or older under actual clinical practice in Japan.
NCT07235397
This study will use a retrospective cohort design and will be conducted within routinely collected national healthcare and statutory demographic datasets held by PHS and National Records of Scotland (NRS). As such, there will be no active enrollment of study participants, no direct contact with study participants, no collection of any primary data outside of the standard of care (SOC), and no requirement for informed consent. This study design was chosen due to several advantages, over other possible designs, including the ability to evaluate incidence of study outcomes in exposed and unexposed infants, ability to follow infants longitudinally to evaluate study outcomes through 12 months of age, and ability to evaluate all-cause outcomes. Study endpoints, including RSV-associated LRTD hospitalization and RSV-associated hospitalization, among infants born to ABRYSVO-vaccinated mothers (exposed group) will be compared with those among infants born to ABRYSVO-unvaccinated mothers (comparison group) initially from birth through 6 months of age, with later analysis from birth through 12 months as the infants reach this age threshold and their data become available.
NCT06604767
The purpose of this phase 1 study is to evaluate whether the vaccine is safe and can help the body to develop germ fighting agents called "antibodies" (immunogenicity) against the respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). The study will use different doses of PIV3 only and different combinations of RSV/hMPV/PIV3 or RSV/hMPV or only RSV vaccine in adults aged 60 years and older.
NCT07346963
Respiratory syncytial virus (RSV) is a leading cause of acute lower respiratory tract infection in infants and young children and contributes substantially to pediatric emergency department (ED) visits and hospitalizations. In Türkiye, nationally representative prospective data describing the epidemiology, clinical spectrum, and resource utilization of RSV-positive children presenting to pediatric EDs remain limited. This multicenter prospective observational study aims to characterize demographic and clinical features of RSV-positive children under 5 years of age presenting to participating pediatric EDs across two consecutive RSV seasons, and to quantify key healthcare utilization outcomes, including ED observation duration, hospitalization, and intensive care unit (ICU) admission.
NCT06614725
The purpose of the study is to evaluate the immunogenicity and safety of a single dose of investigational RSVPreF3 OA vaccine in Indian older adults 60 years of age (YOA) and above and Indian adults 50-59 YOA at increased risk of RSV-LRTD.
NCT07279298
This study aims to evaluate the real-world effectiveness of two preventive immunization strategies against Respiratory Syncytial Virus (RSV)-associated severe acute respiratory infection in infants less than six months of age in Bogotá, Colombia. The strategies include maternal vaccination with RSVpreF administered between 28 and 36 weeks of gestation and neonatal immunization with nirsevimab for infants born to mothers who did not receive RSVpreF during pregnancy. Using a test-negative case-control design embedded in the city's sentinel surveillance system, infants hospitalized for severe respiratory infection will be systematically tested for RSV. Comparative vaccine effectiveness will be estimated to determine the impact of maternal RSV vaccination and neonatal monoclonal antibody immunization on RSV-associated hospitalizations, intensive care admissions, and mortality. The study will generate real-world evidence to inform local and regional public health decisions and guide the implementation of cost-effective hybrid immunization strategies against RSV in middle-income settings.
NCT07239583
This observational, prospective, multicenter study aims to estimate the proportion of RSV infection in adults aged 60 years and older hospitalized due to acute respiratory infections or exacerbation of cardiopulmonary disease.
NCT04491877
The primary objectives of the study were: * To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline serostatus. * To characterize the Respiratory Syncytial Virus (RSV) A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-naïve participants. The secondary objectives of the study were: * To quantify the amount of vaccine virus shed by each participant by baseline serostatus. * To determine the proportion of vaccinated infants and toddlers in each vaccine group infected with the vaccine virus at D56 (56 days after vaccination 1) for Cohorts 1, 2, 3 and 4, and at Day 84 (28 days after vaccination 2) for Cohorts 2 and 4 by baseline serostatus. * To characterize the RSV A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-experienced participants. * To characterize serum RSV anti-F immunoglobulin G (IgG) antibody responses to the study product in each vaccine group after vaccination by baseline serostatus. * To characterize serum RSV antibody responses (RSV A-neutralizing and anti-RSV F IgG) to the study product in each vaccine group after the RSV surveillance season or at least 5 months after the last vaccine administration by baseline serostatus.
NCT06977971
This study retrospectively evaluated the clinical, laboratory, and radiologic factors that influence the decision to prescribe antibiotics in children under 2 years of age hospitalized with RSV-positive acute lower respiratory tract infections. The study also examined the economic impact of antibiotic use in these patients. The goal is to improve clinical decision-making and reduce unnecessary antibiotic exposure in children with viral infections.
NCT05879107
The purpose of this study is to assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with PCV20 and its safety in older adults, aged ≥60 years of age.
NCT02624947
The purpose of this study is to determine the efficacy of maternal immunization during the third trimester of pregnancy with the RSV F vaccine against medically-significant RSV lower respiratory tract infection (LRTI), as defined by hypoxemia or tachypnea at rest, through the first 90, 120, 150, and 180 days of life in infants.
NCT05966090
To assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with HZ/su vaccine and its safety in older adults, aged \>=50 years of age.