Respiratory Syncytial Virus Infections Clinical Trial
Official title:
Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-attenuated Respiratory Syncytial Virus Vaccine, LID cp ΔM2-2, Lot RSV#009B, Delivered as Nose Drops to RSV-Seronegative Infants and Children 6 to 24 Months of Age
The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a
single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in
RSV-seronegative infants and children 6 to 24 months of age.
This study is a companion study to IMPAACT 2012.
Human respiratory syncytial virus (RSV) is the most common viral cause of serious acute lower
respiratory illness (LRI) in infants and children under 5 years of age worldwide. This study
will evaluate the safety, infectivity, and immunogenicity of a single dose of RSV LID cp
ΔM2-2, a recombinant live-attenuated RSV vaccine, in RSV-seronegative infants and children 6
to 24 months of age.
Participants will be randomly assigned to receive a single dose of the RSV LID cp ΔM2-2
vaccine or placebo at study entry (Day 0).
Participants will be enrolled in the study between April 1 and October 31 (outside of RSV
season) and will remain on study until they complete the post-RSV season visit between April
1 and April 30 in the calendar year following enrollment. Participants' total study duration
will be between 6 and 13 months, depending on when they enroll in the study. Participants
will be evaluated in study visits that may include physical examinations, blood collection,
and nasal washes. Additionally, participants' parents or guardians will be contacted by study
staff at various times during the study to monitor participants' health.
;
| 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 | |
| Withdrawn |
NCT02864628 -
RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults.
|
Phase 1 | |
| Completed |
NCT02873286 -
RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults
|
Phase 2 | |
| 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 | |
| Completed |
NCT05590403 -
A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above
|
Phase 3 |