Clinical trials: Respiratory Syncytial Virus Prevention
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
Healthy Volunteers
A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults
The main purposes of this study are to assess the safety, reactogenicity and immunogenicity of 4 dose levels of the bivalent combination Respiratory Syncytial Virus (RSV) / human Metapneumovirus (hMPV) vaccine candidate VXB-241…
- Trial name
- NCT06556147
- Testing
- VXB-241 60 mcg (Low Dose), VXB-241 120 mcg (Medium Dose), VXB-241 240 mcg (Medium-high Dose)
- Where
- 4 sites in Australia
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Sanofi
Antiviral Prophylaxis, Respiratory Syncytial Virus Infection
A Safety and Immunogenicity Study of Intranasal Sendai Virus Vectored Respiratory Syncytial Virus (SeVRSV) Vaccine in Healthy Adults
This is a Phase I randomized, double blind, placebo controlled trial in up to 25 males and non-pregnant females, 18-45 years old, inclusive, who are in good health and meet all eligibility criteria.
- Trial name
- NCT03473002
- Testing
- SeVRSV Vaccine
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Respiratory Syncytial Virus Infection, Premature Birth
Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
- Trial name
- NCT01006629
- Testing
- palivizumab
- Where
- 19 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Abbott
RSV Immunization, Healthy Volunteer
Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life
The purpose of this study was to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to no intervention, for the prevention of hospitalizations due to lower respiratory tract infection…
- Trial name
- NCT05437510
- Testing
- Nirsevimab
- Where
- 240 sites in France, Germany and 1 more
- Volunteers
- 8,057 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Respiratory Syncytial Virus Infection Prevention
A Study to Evaluate the Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older
This is a randomized, observer-blinded, placebo-controlled Phase Ⅱ clinical trial to evaluate the immunogenicity and safety of the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in participants aged 60 years and older.
- Trial name
- NCT07208461
- Testing
- Low dose antigen of LYB005 without A01B adjuvant, Low dose antigen of LYB005 with A01B adjuvant, Middle dose antigen of LYB005 without A01B adjuvant
- Where
- China
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- Guangzhou Patronus Biotech Co., Ltd.
Respiratory Syncytial Virus Infections
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and…
- Trial name
- MELODY (NCT03979313)
- Testing
- MEDI8897
- Where
- 198 sites in United States, Argentina and 29 more
- Volunteers
- 3,012 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Respiratory Syncytial Virus Infections
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
The 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.
- Trial name
- NCT06083623
- Testing
- TNM001
- Where
- 39 sites in China
- Volunteers
- 2,282 people, healthy volunteers welcome
- Sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
Respiratory Syncytial Virus-associated Lower Respiratory Tract Disease Prevention
A Study of Various Respiratory Syncytial Virus (RSV) Pre-Fusion (preF)-Based Vaccine Formulations in Adults Aged 60 Years and Older
The purpose of the study is to evaluate safety and immunogenicity of various respiratory syncytial virus (RSV) pre-Fusion (preF)-based vaccine components followed by expanded safety evaluation and durability/revaccination…
- Trial name
- NCT05327816
- Testing
- RSV preF-based Vaccine
- Where
- 11 sites in United States
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Respiratory Syncytial Virus Infection, Healthy Volunteers
Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older
The purpose of this study is to evaluate the safety and immunogenicity an investigational messenger ribonucleic acid (mRN)A vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Healthy Volunteers, Metapneumovirus Infection
- Trial name
- NCT06237296
- Testing
- RSV/hMPV mRNA LNP 1, RSV/hMPV mRNA LNP 2, RSV mRNA LNP 1
- Where
- 17 sites in United States, Australia
- Volunteers
- 558 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Respiratory Syncytial Virus Prevention
A Study of Adenovirus Serotype 26.Respiratory Syncytial Virus.Pre-Fusion F (Ad26.RSV.preF)-Based Vaccine for Prevention of Respiratory Syncytial Virus (RSV) Mediated- Lower Respiratory Tract Disease (LRTD) in Japanese Participants
The purpose of the study is to evaluate the efficacy of study vaccine in the prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-confirmed RSV mediated- lower Respiratory Tract Disease (LRTD) over one RSV…
- Trial name
- NCT05242432
- Testing
- Ad26/protein preF RSV Vaccine
- Where
- 30 sites in Japan
- Volunteers
- 2,192 people
- Sponsor
- Janssen Pharmaceutical K.K.
Respiratory Syncytial Virus Infection Prevention
A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection
The purpose of the study is to investigate the safety and immunogenicity of the Ad26.RSV.preF based vaccine in adults 18 to 59 years of age who are healthy or at risk for severe Respiratory Syncytial Virus (RSV) disease, compared…
- Trial name
- NCT05070546
- Testing
- Ad26.RSV.preF-based Vaccine
- Where
- 23 sites in United States, Belgium and 3 more
- Volunteers
- 1,124 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Respiratory Syncytial Virus Prevention
A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old
The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses induced by vaccination with one dose of the Phase 3 clinical trial material (CTM) compared with one dose of the Phase 2b CTM.
- Trial name
- NCT05083585
- Testing
- Ad26.RSV.preF-based vaccine
- Where
- 9 sites in United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
RSV
Stakeholder-Informed RSV Prevention Economic Model in Botswana
The goal of this mixed methods study is to engage stakeholders to develop a health economic model to estimate the costs, health benefits, and value of respiratory syncytial virus (RSV) prevention strategies.
- Trial name
- NCT07756528
- Where
- Botswana
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Respiratory Syncytial Viral Infections
Phase I Study for SynGEM, an Intranasal Respiratory Syncytial Virus (RSV) Prefusion F Subunit Candidate Vaccine
The study is a double-blind (within dose level), placebo-controlled Phase I study to assess the safety, reactogenicity and tolerability of two intranasal dose levels of SynGEM®: a low dose level (140 μg F-protein/2mg BLPs) and a…
- Trial name
- SynGEM (NCT02958540)
- Testing
- SynGEM
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Mucosis BV
Respiratory Syncytial Virus Infections
Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children
The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among…
- Trial name
- NCT00129766
- Testing
- motavizumab (MEDI-524), palivizumab
- Where
- 344 sites in United States, Argentina and 22 more
- Volunteers
- 6,635 people
- Sponsor
- MedImmune LLC
Respiratory Syncytial Viral (RSV) Infection, Respiratory Syncytial Virus Hospitalizations
First Year Impact of Nirsevimab on Paediatric Respiratory Syncytial Virus Infection and Hospitalisations in the Australian Capital Territory
The goal of this observational study is to explore the impact of a new prevention medicine (nirsevimab) on the burden of Respiratory Syncytial Virus (RSV) disease in children under 2 years of age.
- Conditions
- Respiratory Syncytial Viral (RSV) Infection, Respiratory Syncytial Virus Hospitalizations, Respiratory Syncytial Virus Prevention
- Trial name
- NCT07177508
- Where
- Australia
- Volunteers
- 2,355 people
- Sponsor
- Nicola Irwin
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
Respiratory Syncytial Virus Infection Prevention, Tuberculosis Prevention
rBCG-N-RSV Vaccine in Adults Aged 60 Years and Older
This Phase 2 clinical study will evaluate the safety of the rBCG-N-RSV vaccine compared to conventional BCG in adults older than 60 years.
- Trial name
- NCT07762014
- Testing
- Vaccination with rBCG-N-RSV, Vaccination with conventional BCG (BCG-WT)
- Where
- Greece
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Biothervax SpA
Atopic Asthma, Recurrent Wheezing
Effects of Preventive Treatment for Respiratory Syncytial (RS) Virus Infection During Infancy on Later Atopic Asthma in Preterm Infants
The primary objective of the study is to determine whether the incidence of atopic asthma after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for…
- Trial name
- NCT01545245
- Volunteers
- 343 people
- Sponsor
- Tokai University