Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06077656
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-13
First Post:
2023-10-05
Brief Title:
Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine
Sponsor:
Inventprise Inc
Organization:
Inventprise Inc
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Active-Controlled Observer-Blind Dose-Ranging Study to Evaluate the Safety Tolerability and Immunogenicity of a 25-Valent Pneumococcal Conjugate Vaccine in Healthy PCV-Naïve Adults
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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:
Phase 2 trial to evaluate safety tolerability and immunogenicity of Inventprises IVT 25-valent pneumococcal conjugate vaccine IVT PCV-25
Detailed Description:
A Phase 2 multicenter randomized active-controlled observer-blind study to evaluate safety tolerability and immunogenicity of three formulations of IVT PCV-25 a 25 valent conjugated pneumococcal vaccine with adjuvant Adult participants will be randomized in a 4322 ratio to receive 1 of 3 formulations or control
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None