Clinical trials: Respiratory Syncytial Virus Immunization
Respiratory Syncytial Virus Hospitalizations
An Observational Study of Respiratory Syncytial Virus (RSV) Hospitalizations in Preterm Infants
Purpose of this study is to evaluate clinical, humanistic and health economic burden of Respiratory Syncytial Virus (RSV) in infants born 29 to 35 Weeks Gestational Age (wGA) hospitalized for RSV at up to 12 months of age.
- Trial name
- SENTINEL1 (NCT02273882)
- Where
- 44 sites in United States
- Volunteers
- 497 people
- Sponsor
- AstraZeneca
Respiratory Syncytial Virus Immunization
Study of a Respiratory Syncytial Virus Candidate Encapsulated in a Lipid Nanoparticle Based Formulation in Adults Aged 18 to 50 Years and 60 Years and Older
Brief Summary of Stage 1: The purpose of Stage 1 (Phase I/IIa) was to assess the safety and immunogenicity of a single intramuscular (IM) injection of 3 dose-levels of an Respiratory Syncytial Virus (RSV) vaccine candidate…
- Trial name
- NCT05639894
- Testing
- RSV vaccine candidate
- Where
- 33 sites in United States, Australia and 1 more
- Volunteers
- 865 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Respiratory Syncytial Virus (RSV), Maternal Immunization
TARSILA Real-World Evidence Study
The overall objective of Tarsila Study is to estimate the real-world vaccine effectiveness of maternal RSVpreF immunization during pregnancy in Brazil against medically attended (inpatient and outpatient) respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus (RSV), Maternal Immunization, Acute Respiratory Illness (ARI), Lower Respiratory Tract Disease
- Trial name
- TARSILA (NCT07445763)
- Testing
- respiratory syncytial virus bivalent prefusion F vaccine
- Volunteers
- 5,000 people
- Sponsor
- Inova Medical
Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus
STudy of Real World vaccinE Effectiveness of maTernal RSVpreF vaccinatiON Against Respiratory Syncytial Virus (RSV) in Hospitalised Infants in Australia (STREETON)
This Pfizer-sponsored real-world retrospective non-interventional study will be conducted within a research network comprised of independent hospitals across Australia using data collected during routine standard of care clinical…
- Conditions
- Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus, Lower Respiratory Tract Disease, Respiratory Tract Diseases
- Trial name
- STREETON (NCT07122661)
- Testing
- ABRYSVO
- Where
- Australia
- Volunteers
- 1 people
- Sponsor
- Pfizer
Healthy
A Study to Evaluate the Single Vaccination of an Adenovirus Serotype 26 Pre-Fusion F (Ad26.preF) Based Respiratory Syncytial Virus (RSV) Vaccine in Japanese Adults Aged 60 Years and Older
The main purpose of this study is to assess the safety and reactogenicity of the Ad26.preF based RSV vaccine administered intramuscularly as a single injection versus placebo in Japanese adults aged greater than equal to 60 years.
- Trial name
- NCT04354480
- Testing
- RSV Vaccine
- Where
- Japan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutical K.K.
RSV Infection
Prevention Strategy for Respiratory Syncytial Virus (RSV) Infections in Infants in France
Bronchiolitis is a viral lower respiratory tract infection, caused in 50 to 80% of cases by the respiratory syncytial virus (RSV).
- Trial name
- SPIRAV (NCT06881953)
- Testing
- Questionnaire
- Where
- France
- Volunteers
- 400 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
RSV Infections, RSV Immunisation
A Clinical Trial on Safety in Pregnant Women and How Well the Infant is Protected Against RSV-associated Lower Respiratory Tract Infection When the Pregnant Woman Receives the Approved RSV Vaccine Compared to a Placebo.
Respiratory syncytial virus (RSV) is a virus that often affects children during childhood. Even though most cases of RSV are mild, it can cause serious disease and even death - especially in very young babies, babies born too…
- Conditions
- RSV Infections, RSV Immunisation, Preterm Labour
- Trial name
- NCT06955728
- Testing
- Vaccine
- Where
- 11 sites in Ghana, Kenya and 2 more
- Volunteers
- 13,000 people, healthy volunteers welcome
- Sponsor
- University of Witwatersrand, South Africa
Heart Failure, RSV Infection
Coordinated Vaccination Against RSV and Influenza in Patients With Chronic Heart Failure and Its Impact on Prognosis.
This prospective, single-centre, open-label, randomized study aims to determine whether coordinated care in administering protective vaccinations (against Respiratory Syncytial Virus (RSV) and influenza) impacts the prognosis of…
- Conditions
- Heart Failure, RSV Infection, Influenza, Vaccines
- Trial name
- VACCINE-CHF (NCT06259487)
- Testing
- Coordinated Vaccination, Following recommendations
- Where
- Poland
- Volunteers
- 250 people
- Sponsor
- Wroclaw Medical University
Respiratory Syncytial Virus Infections
Evaluation of RSV/Flu-01E Vaccine for the Prevention of RSV Infection in Volunteers Aged 18 to 59 Years and Over 60 Years
The aim of the study is to investigate the safety and immunogenicity of the RSV/Flu-01E vaccine for the prevention of respiratory syncytial virus infection in volunteers aged18 to 59 years and over 60 years.
- Trial name
- NCT05970744
- Testing
- RSV/Flu-01E low dose, RSV/Flu-01E high dose
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Tatyana Zubkova
Bronchiolitis, Respiratory Syncytial Virus (RSV)
Evaluation in Practice of the Impact of NIrsevimab on EmeRgency Use for BRONCHIOlitis
In July 2023, the Food and Drug Administration approved nirsevimab (Beyfortus®), a long-acting monoclonal antibody, for passive immunization to prevent RSV-associated lower respiratory tract infection (Bronchiolitis) among…
- Conditions
- Bronchiolitis, Respiratory Syncytial Virus (RSV), Immunization; Infection
- Trial name
- EPINIR-BRONC (NCT06185647)
- Testing
- No intervention. Observational retrospective study
- Where
- France
- Volunteers
- 4,924 people
- Sponsor
- Hôpital Armand Trousseau
Respiratory Syncytial Virus Infection
The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products
Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract infections (LRTIs) in infants and young children. It is also a leading cause of mortality in children <5 years of age worldwide.
- Trial name
- NCT06551506
- Testing
- Abrysvo, Beyfortus
- Where
- 8 sites in United States
- Volunteers
- 181 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Respiratory Syncytial Virus (RSV), Infectious Disease
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
The goal of this clinical trial is to assess the safety, reactogenicity and immunogenicity of an mRNA-based vaccine, JCXH-108, the prevention of Respiratory Syncytial Virus (RSV) infection and diseases.
- Trial name
- NCT06564194
- Testing
- JCXH-108
- Where
- 3 sites in United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Immorna Biotherapeutics, Inc.
RSV Immunisation
Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers
This study is a phase III, randomized, observer-blind, placebo-controlled, multinational, multi-center study to be conducted in approximately 6300 children 6 months to < 22 months of age.
- Trial name
- PEARL (NCT06252285)
- Testing
- RSVt Vaccine
- Where
- 130 sites in United States, Argentina and 14 more
- Volunteers
- 6,300 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Respiratory Syncytial Virus Infections
A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization
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…
- Trial name
- NCT02624947
- Testing
- RSV F vaccine with adjuvant, Formulation buffer
- Where
- 88 sites in United States, Argentina and 9 more
- Volunteers
- 4,636 people, healthy volunteers welcome
- Sponsor
- Novavax
Respiratory Syncytial Virus (RSV)
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
This clinical trial is being done to learn more about how well a vaccine (Arexvy®) for respiratory syncytial virus, also known as RSV, works in people with weakened immune systems.
- Trial name
- STRIVE (NCT07050732)
- Testing
- Arexvy (2 doses total), Arexvy (3 doses total), Arexvy (1 dose total)
- Where
- United States
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Infections, Respiratory Syncytial Virus
Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccines
The purpose of this first time in human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of Respiratory Syncytial Virus (RSV) investigational vaccines in healthy men.
- Trial name
- NCT01905215
- Testing
- RSV vaccine GSK3003892A (formulation 1), RSV vaccine GSK3003893A (formulation 2), RSV vaccine GSK3003895A (formulation 3)
- Where
- 3 sites in Canada
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infections
An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study
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…
- Trial name
- RSV OA=ADJ=012 (NCT06534892)
- Testing
- RSVPreF3 OA vaccine
- Where
- 251 sites in United States, Australia and 15 more
- Volunteers
- 10,212 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Immunization
Repeated Cross Sectional Surveillance Study To Determine the Respiratory Syncytial Virus (RSV) Immunization Rates in German Infants
In June 2024, the German Standing Committee on Vaccination (STIKO) recommended the universal immunization of infants with nirsevimab during their first RSV season.
- Trial name
- Vakzimeter RSV (NCT06824207)
- Where
- Germany
- Volunteers
- 2,400 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Respiratory Syncytial Viral (RSV) Infections
Duration of Protection of Nirsevimab Against Hospitalisation for Respiratory Syncytial Virus Infection
Respiratory syncytial virus (RSV) is a leading cause of hospitalizations for acute lower respiratory tract infection (LRTI) in infants.
- Trial name
- NCT06993753
- Where
- Australia
- Volunteers
- 4,350 people
- Sponsor
- Griffith University
Healthy Volunteers, Influenza Vaccination
A Study on the Safety and Immunogenicity of Influenza, Respiratory Syncytial Virus, Human Metapneumovirus and Parainfluenza Vaccines in Adults 18 to 49 Years of Age.
The objective of this study is to evaluate the safety and immunogenicity of different vaccines of hemagglutinin formulations of trivalent influenza vaccine or of a combined respiratory syncytial virus / human metapneumovirus /…
- Conditions
- Healthy Volunteers, Influenza Vaccination, Respiratory Syncytial Virus Vaccination, Parainfluenza Vaccination
- Trial name
- NCT06850051
- Testing
- TIV-HA Vaccine formulation 1 at low dose, TIV-HA formulation 1 at high dose, TIV-HA formulation 2 at low dose
- Where
- 6 sites in Australia
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Sanofi