Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562790
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-18
Brief Title:
Study of Gamma PN3 in the Elderly
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Randomised Active-controlled Blinded Dose-ranging Study of the Safety Tolerability and Immunogenicity of an Inactivated Whole-cell Pneumococcal Vaccine Gamma-PN3 in Elderly Participants
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:
Phase 1 double- blind randomised active comparator dose escalating study of Gamma PN3 in the elderly
Detailed Description:
The study is a phase 1 randomised active-controlled double-blind sequential ascending-dose study to evaluate the safety tolerability and immunogenicity of Gamma-PN3 in elderly adults Three sequential ascending dose cohorts are planned with 35 participants per cohort randomised to one of two treatment arms Administration of allocated study treatments will be on Days 1 and 29 with one treatment arm consisting of two doses of Gamma-PN3 and the treatment arm consisting of the comparator vaccine Prevenar 13 one dose only with second dose of Placebo
Immunogenicity will be assessed at Day 29 and Day 57
Immunogenicity will be assessed at Day 29 and Day 57
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