Clinical trials: Respiratory Syncytial Virus Prevention
Motavizumab Administration for a Second Season for RSV Prophylaxis
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children
The primary objective of this study was to determine the effect on immune reactivity to motavizumab (MEDI-524) of monthly intramuscular (IM) doses of motavizumab (MEDI-524) administered for a second season in children.
- Trial name
- NCT00113490
- Testing
- motavizumab (MEDI-524), palivizumab 15 mg/kg
- Where
- 6 sites in Brazil, Chile
- Volunteers
- 136 people
- Sponsor
- MedImmune LLC
Respiratory Syncytial Virus Infections
Study to Evaluate the Incidence of Hospitalizations and Respiratory Tract Infections in Premature Infants
The purpose of this study is to describe respiratory syncytial virus (RSV) hospitalization rates and to begin to address the utilization of outpatient resources for RSV medically-attended lower respiratory tract infections…
- Trial name
- NCT00384462
- Where
- 59 sites in United States
- Volunteers
- 346 people
- Sponsor
- MedImmune LLC
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
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, 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
Healthy
MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States
MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American Infants in the…
- Trial name
- NCT00121108
- Testing
- Motavizumab
- Where
- 12 sites in United States
- Volunteers
- 2,127 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
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
Respiratory Syncytial Virus Infection
Synagis® Liquid 50mg, 100mg for Intramuscular Injection Special Investigation in Immunocompromised Children With Synagis®
This post marketing observational study (PMOS) was conducted in Japan during the 2013-2014 and 2014-2015 Respiratory Syncytial Virus (RSV) seasons to assess the safety and effectiveness of palivizumab for the prevention of…
- Trial name
- NCT02016690
- Volunteers
- 312 people
- Sponsor
- AbbVie
Respiratory Syncytial Virus Infections
A Phase III, Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers
The purpose of this study was to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly (IM) to pregnant women aged 18-49 years, in good general maternal health, in…
- Trial name
- GRACE (NCT04605159)
- Testing
- RSV MAT
- Where
- 159 sites in United States, Argentina and 22 more
- Volunteers
- 11,194 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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 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.
Respiratory Syncytial Virus Infections
Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants
The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age…
- Trial name
- NCT02325791
- Testing
- Suptavumab 30 mg/kg, Suptavumab 30 mg/kg- 1 Dose, Suptavumab 30 mg/kg - 2 Doses
- Where
- 205 sites in United States, Australia and 17 more
- Volunteers
- 1,177 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
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.
RSV Infection, hMPV
Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years
VAV00039 is a first-in-human (FiH) study to assess the safety and immunogenicity (in adult participants aged 60-75 years) after a single injection of different dose formulations of an RSV/hMPV vaccine candidate and RSV vaccine.
- Trial name
- NCT06583031
- Testing
- RSV/hMPV vaccine dose A1, RSV/hMPV vaccine dose A2, RSV/hMPV vaccine dose A3
- Where
- 6 sites in Australia
- Volunteers
- 385 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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 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
A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children
The purpose of this study is to evaluate the safety and tolerability of MEDI8897 compared to palivizumab when administered to preterm infants entering their first RSV season and children with chronic lung disease (CLD) and…
- Trial name
- NCT03959488
- Testing
- MEDI8897, Palivizumab
- Where
- 128 sites in United States, Austria and 24 more
- Volunteers
- 925 people
- Sponsor
- AstraZeneca
Respiratory Syncytial Virus
A Study to Evaluate the Efficacy of MEDI7510 in Older Adults
This study will be the first assessment of the efficacy of MEDI7510 for the prevention of respiratory syncytial virus (RSV) disease. It will also provide estimates of vaccine efficacy and of endpoint incidence in the placebo arm.
- Trial name
- NCT02508194
- Testing
- MEDI7510, IIV
- Where
- 61 sites in United States, Canada and 5 more
- Volunteers
- 1,900 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Respiratory Syncytial Virus Infection
ALX-0171 Safety Study in Adults With Hyperresponsive Airways
This is a Phase I, single-centre, open label study to evaluate the occurrence and subsequent reversibility and prevention, of bronchoconstriction following single and repeated oral inhalations of ALX-0171 in adults with…
- Trial name
- NCT01909843
- Testing
- ALX-0171
- Where
- Germany
- Volunteers
- 24 people
- Sponsor
- Ablynx, a Sanofi company
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