Clinical trials: Respiratory Syncytial Virus Infection Prevention
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.
Influenza, Human Prevention, Respiratory Syncytial Viruses Prevention
A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older
The purpose of this study is to evaluate the immunogenicity and safety of Ad26.RSV.preF-based vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either concomitantly or separately.
- Trial name
- NCT05071313
- Testing
- Ad26.RSV.preF-based vaccine, Quadrivalent High-dose Influenza Vaccine
- Where
- 19 sites in United States
- Volunteers
- 777 people
- Sponsor
- Janssen Vaccines & Prevention B.V.
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.
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
RSV Immunization
Pregnancy and Infant PrEparedness pLatform IN Europe, RSV-International Adaptive Platform Trial to Evaluate Two Approved Prevention Options to Prevent Respiratory Syncytial Virus in Infants: Maternal Vaccine to Women in Pregnancy and Monoclonal Antibody to the Infants, Given Alone or in Combination.
RSV (which stands for Respiratory Syncytial Virus) is an infection that causes cold-like symptoms and is most common during winter months.
- Trial name
- PIPELINE-RSV (NCT07041190)
- Testing
- Abrysvo, Nirsevimab
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- PENTA Foundation
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 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 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 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 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
Children <24 Months Hospitalized for RSV-related Lower Respiratory Tract Infection
Severe Pediatric Respiratory Syncytial Virus Infections Occurring in the Era of Antiviral Prophylaxis
Hospitalization for RSV lower respiratory tract infections (LRTI) still occurs, including in infants having received nirsevimab/clesrovimab or born to mothers vaccinated with Abrysvo.
- Trial name
- SiRiUS (NCT07893652)
- Testing
- Prior exposure to prophylactic treatment with Abrysvo or nirsevimab/clesrovimab, Non-exposure to prior prophylactic treatment
- Where
- France
- Volunteers
- 300 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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 Viruses, Respiratory Tract Diseases
A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older
The purpose of this study is to demonstrate the efficacy of active study vaccine in the prevention of reverse transcriptase polymerase chain reaction (RT-PCR) confirmed respiratory syncytial virus (RSV)-mediated lower respiratory…
- Trial name
- CYPRESS (NCT03982199)
- Testing
- RSV Vaccine
- Where
- 40 sites in United States
- Volunteers
- 5,815 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Respiratory Syncytial Virus Prevention
A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based…
- Trial name
- NCT05101486
- Testing
- Ad26.RSV.PreF-based Vaccine
- Where
- 13 sites in United States
- Volunteers
- 755 people
- Sponsor
- Janssen Vaccines & Prevention B.V.
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
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 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
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