Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523231
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Study to Expand Safety and Immunogenicity Data With Shigella Bioconjugate Vaccine Shigella4V2 in 9-month-old Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Immunogenicity of a Second Generation Shigella Bioconjugate Vaccine a Phase II Randomized Controlled and Blinded Study in 9-month-old Infants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
S4V02
Brief Summary:
In this study the second-generation tetravalent bioconjugate candidate vaccine Shigella4V2 will be tested to confirm data on its safety and immunogenicity in infants and to identify the best dose of Shigella4V2 in 9-month-old infants
Detailed Description:
Shigella4V2 is the second generation of a tetravalent bioconjugate vaccine including O-antigen-polysaccharides of the most predominant Shigella serotypes
During the study infants will be randomized to receive 1 of 2 different vaccine doses or a control vaccine
Participants will receive a 2-dose schedule Each vaccine dose is formulated with Aluminium adjuvant
During the study infants will be randomized to receive 1 of 2 different vaccine doses or a control vaccine
Participants will receive a 2-dose schedule Each vaccine dose is formulated with Aluminium adjuvant
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