Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551181
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
A Study on the Immune Response Safety and the Occurrence of Respiratory Syncytial Virus RSV-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and Older
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Randomized Controlled Partially Blind Immuno-bridging Study to Evaluate Immunogenicity Reactogenicity Safety and the Occurrence of RSV Associated Respiratory Tract Illness After Administration of a Single Dose of GSKs RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Older
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the current study is to evaluate the immune response of the RSVPreF3 OA investigational vaccine in older adults OA at least 60 years of age YOA in China compared to OA in the same age range to be enrolled from overseas countries that participated in the RSV OAADJ-006 NCT04886596 study since the vaccine efficacy against lower respiratory tract disease LRTD has been demonstrated following a single dose of the RSVPreF3 OA investigational vaccine in the global efficacy study RSV OAADJ-006 In addition the safety in all participants reactogenicity and occurrence of RSV-associated acute respiratory illness ARI in study participants in China only after administration of the vaccine are also assessed in the current study No ARI surveillance will be conducted for the overseas participants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None