Clinical trials: RSV Infections
Respiratory Syncytial Virus Infections
Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
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…
- Trial name
- NCT04732871
- Testing
- RSVPreF3 OA investigational vaccine
- Where
- 46 sites in United States, Finland and 3 more
- Volunteers
- 1,720 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infections
A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab
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.
- Trial name
- JUBILUS (NCT06042049)
- Testing
- Nirsevimab
- Where
- 9 sites in Japan
- Volunteers
- 33 people
- Sponsor
- AstraZeneca
Respiratory Syncytial Virus Prophylaxis
Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection
The purpose of this study is to determine the safety of motavizumab (MEDI-524) following a single intravenous dose in children hospitalized with respiratory syncytial virus (RSV).
- Trial name
- NCT00192504
- Testing
- Motavizumab
- Volunteers
- 31 people
- Sponsor
- MedImmune LLC
Respiratory Syncytial Virus Infection
Study on a Live-attenuated Respiratory Syncytial Virus Vaccine for Assessment of Safety, Transmissibility, and Genetic Stability of the Vaccine Virus Among Close Contacts in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA)
The primary purpose of the study is to assess the shedding, transmission, and genetic stability of the live-attenuated RSVt vaccine after each intranasal vaccination (56 days apart) in infants and toddlers 6 to < 24 months of age.
- Trial name
- NCT05687279
- Testing
- RSVt Vaccine, Control Group
- Where
- 6 sites in United States, Puerto Rico
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Respiratory Syncytial Virus Infection
A Study to Learn How the Study Medicine Called Sisunatovir is Tolerated and Acts in the Bodies of Chinese Healthy Adults.
The purpose of the study is to learn about: The activity of sisunotavir in the body over a period. It includes the processes by which sisunotavir is absorbed, distributed in the body, localized in the tissues, and removed from…
- Trial name
- NCT05987072
- Testing
- Sisunatovir
- Where
- 3 sites in China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Respiratory Syncytial Virus Infections
A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above
The purpose of this study is to assess the lot-to-lot consistency in terms of immunogenicity and evaluate the safety and reactogenicity of 3 lots of the RSVPreF3 OA investigational vaccine administered as a single dose in adults…
- Trial name
- NCT05059301
- Testing
- RSVPreF3 OA investigational vaccine
- Where
- 19 sites in United States, Canada and 1 more
- Volunteers
- 770 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infections
A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in RSV-seropositive Infants
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of the respiratory syncytial virus (RSV) candidate vaccine when first administered via intramuscular (IM) injection according to a 0, 1-month…
- Trial name
- NCT02927873
- Testing
- RSV (GSK3389245A) low dose formulation vaccine, RSV (GSK3389245A) middle dose formulation vaccine, RSV (GSK3389245A) high dose formulation vaccine
- Where
- 24 sites in United States, Canada and 6 more
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Viruses, Lower Respiratory Tract Disease
A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older
The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed…
- Trial name
- EVERGREEN (NCT04908683)
- Testing
- Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF
- Where
- 272 sites in United States, Australia and 12 more
- Volunteers
- 25,236 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Respiratory Syncytial Virus Infections
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above
The aim of this study is to demonstrate the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for RSV…
- Trial name
- NCT06389487
- Testing
- RSVPreF3 OA investigational vaccine
- Where
- 52 sites in United States, Australia and 4 more
- Volunteers
- 1,459 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Severe Respiratory Syncytial Virus Infection
Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease
Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that…
- Trial name
- NCT01075178
- Where
- 37 sites in Austria, Belgium and 8 more
- Volunteers
- 2,036 people
- Sponsor
- Abbott
Respiratory Tract Infection
A STUDY OF A RSV VACCINE WHEN GIVEN TOGETHER WITH TDAP IN HEALTHY NONPREGNANT WOMEN AGED BETWEEN 18 TO 49 YEARS
This phase 2b study will evaluate safety, tolerability, and immunogenicity of an RSV vaccine when given together with Tdap in approximately 710 healthy nonpregnant women 18 through 49 years of age.
- Trial name
- NCT04071158
- Testing
- RSV Vaccine, Tdap
- Where
- 16 sites in United States
- Volunteers
- 713 people, healthy volunteers welcome
- Sponsor
- Pfizer
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 Virus Infections
Study of RSVpreF Vaccination and RSV Challenge in Healthy Adults
In this randomised, placebo-controlled, double-blind Phase 2a study, healthy male and female participants 18-50 years of age will be given an investigational RSV vaccine (RSVpreF) and challenged with RSV one month later.
- Trial name
- NCT04785612
- Testing
- RSVPreF
- Where
- United Kingdom
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Hvivo
RSV Infection
Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults
Gates MRI-RSM01-101 was a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and tolerability, pharmacokinetics, occurrence of Anti-drug antibody (ADA), and assessment of…
- Trial name
- NCT05118386
- Testing
- RSM01
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
Respiratory Tract Infection
A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN
This Phase 2b study will evaluate the safety, tolerability, and immunogenicity of an RSV vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or…
- Trial name
- NCT04032093
- Testing
- RSV vaccine
- Where
- 159 sites in United States, Argentina and 3 more
- Volunteers
- 1,153 people, healthy volunteers welcome
- Sponsor
- Pfizer
Respiratory Synctial Virus Infections
A Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' RSV Investigational Vaccine (ChAd155-RSV) (GSK3389245A) in Healthy Adults
The purpose of this first time in human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of 2 doses of the RSV investigational vaccine, when administered intramuscularly according to a 0, 1 month schedule…
- Trial name
- NCT02491463
- Testing
- GSK3389245A_LD GROUP, GSK3389245A_HD GROUP, Bexsero
- Where
- United Kingdom
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infections
A Study on the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers
The purpose of this study was to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of the respiratory syncytial virus (RSV) maternal vaccine compared to placebo, when administered in the…
- Trial name
- NCT04980391
- Testing
- RSV MAT
- Where
- 35 sites in United States, Brazil and 7 more
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infections
A Study to Assess Safety, Tolerability and Immunogenicity of the Live Attenuated hRSV Vaccine rBCG-N-hRSV
Human respiratory syncytial virus (hRSV) is the main cause of lower respiratory tract infection in children under one year of age.
- Trial name
- EVA-VRS01 (NCT03213405)
- Testing
- rBCG-N-hRSV 1/100, rBCG-N-hRSV 1/10, rBCG-N-hRSV full dose
- Where
- Chile
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pontificia Universidad Catolica de Chile
Respiratory Syncytial Virus Infections
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
The purpose of this study was to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy adult…
- Trial name
- NCT02114268
- Testing
- MEDI8897 Intravenous, MEDI8897 Intramuscular
- Where
- United States
- Volunteers
- 342 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Respiratory Syncytial Virus Infection
Surveillance of Synagis in Korean Pediatric Patients
Approximately 600 pediatric patients prescribed palivizumab (Synagis) prophylaxis in usual practice according to the approved Korean product label will be registered into this observational study.
- Trial name
- NCT01537198
- Volunteers
- 618 people
- Sponsor
- AbbVie (prior sponsor, Abbott)