Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT04583618
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2020-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years.
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults Aged 50 to 84 Years
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objectives:
* Assessed the immune response of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23 30 days after the administration of the single dose vaccination
* Assessed the safety profile of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23
* Assessed the immune response of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23 30 days after the administration of the single dose vaccination
* Assessed the safety profile of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23
Detailed Description:
The duration of each participant's participation was approximately 6 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1238-9824 | REGISTRY | ICTRP | View |