Respiratory Syncytial Virus Infections Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled Phase 1 Trial of the RSV/Flu-01E Vaccine for the Prevention of Respiratory Syncytial Virus 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.
Study includes 60 participants in three cohorts. First cohort includes 15 volunteers aged 18 to 59, randomized at 2:1 ratio, to receive low dose RSV/Flu-01E vaccine or placebo, correspondingly. Second cohort includes 15 volunteers aged 18 to 59, randomized at 2:1 ratio, to receive high dose RSV/Flu-01E vaccine or placebo, correspondingly. Third cohort includes 30 participants aged 60 years and older, randomized at 2:1 ratio to receive high dose RSV/Flu-01E vaccine or placebo. Duration of the study for each participant is about 6 months (no more than 190 days). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03698084 -
RESCEU: Defining the Burden of RSV Disease
|
||
Completed |
NCT04090658 -
A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults
|
Phase 1 | |
Completed |
NCT04231968 -
A Study of AK0529 in Chinese Infants Hospitalized With RSV
|
Phase 3 | |
Completed |
NCT03227029 -
Evaluating the Infectivity, Safety, and Immunogenicity of Recombinant Live-Attenuated RSV Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants 6 to 24 Months of Age
|
Phase 1 | |
Terminated |
NCT02948127 -
Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (RSV LID cp ΔM2-2) in RSV-Seronegative Infants and Children 6 to 24 Months of Age
|
Phase 1 | |
Completed |
NCT02873286 -
RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults
|
Phase 2 | |
Withdrawn |
NCT02864628 -
RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults.
|
Phase 1 | |
Completed |
NCT02984280 -
Specific Respiratory Infections as Triggers of Acute Medical Events
|
N/A | |
Completed |
NCT02237209 -
Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
|
Phase 1 | |
Completed |
NCT02247726 -
RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women.
|
Phase 2 | |
Completed |
NCT02040831 -
Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
|
Phase 1 | |
Completed |
NCT01915394 -
Respiratory Syncytial Virus Infection in Neonatal Intensive Care Units Throughout Turkey: Prospective Multicenter Study (TurkNICU-RSV Trial)
|
N/A | |
Completed |
NCT01355016 -
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT00232635 -
A Study of the Safety and Efficacy of A-60444 in Adults With Respiratory Syncytial Virus (RSV) Infection Following HSCT
|
Phase 2 | |
Completed |
NCT01155193 -
Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
|
||
Not yet recruiting |
NCT06083623 -
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
|
Phase 2/Phase 3 | |
Terminated |
NCT02890381 -
Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (RSV LID cp ΔM2-2) in RSV-Seronegative Infants 6 to 24 Months of Age
|
Phase 1 | |
Active, not recruiting |
NCT03422237 -
Evaluating the Infectivity, Safety, and Immunogenicity of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants and Children 6 to 24 Months of Age
|
Phase 1 | |
Completed |
NCT03674177 -
A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women
|
Phase 1 | |
Completed |
NCT01968083 -
Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
|
Phase 1 |