Respiratory Syncytial Virus Infections Clinical Trial
Official title:
A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above
This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and in Southern Hemisphere (SH). This study will also assess if the vaccine is safe and induces an immune response.
Dose 1 Period will be conducted in 2 parts: Part 1: Participants in RSVPreF3 groups will receive lots 1, 2 and 3 of the investigational vaccine before Season 1. Part 2: Will be initiated when the vaccine lots in part 1 are exhausted at the study sites and participants in RSVPreF3 group will receive lot 4 of the investigational vaccine before Season 1. ;
| 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 | |
| Completed |
NCT02984280 -
Specific Respiratory Infections as Triggers of Acute Medical Events
|
N/A | |
| Completed |
NCT02873286 -
RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults
|
Phase 2 | |
| 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 | |
| Withdrawn |
NCT02864628 -
RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults.
|
Phase 1 | |
| Completed |
NCT02237209 -
Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
|
Phase 1 | |
| Completed |
NCT02040831 -
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 |
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 |