Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534892
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OAADJ-006 Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3b Randomized Open Label Multicountry Multi-center Extension and Crossover Vaccination Study to Evaluate the Immunogenicity and Safety of Different Revaccination Schedules and Persistence of a Single Dose of the RSVPreF3 OA Vaccine in Adults Aged 60 Years and Above Who Participated in the RSV OAADJ-006 Study
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:
RSV OAADJ012
Brief Summary:
The purpose of this study is
To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose
To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons approximately 60 months of a single dose of RSVPreF3 OA vaccine
To give the opportunity to participants who received only placebo in the RSVOAADJ- 006 study to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information
To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose
To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons approximately 60 months of a single dose of RSVPreF3 OA vaccine
To give the opportunity to participants who received only placebo in the RSVOAADJ- 006 study to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information
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