Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611371
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Phase III Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise Inc in Healthy Non-Pregnant Adult Women of Childbearing Age WOCBA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Observer-Blind Randomized Placebo-Controlled Dose-Selection Study to Assess the Safety Tolerability and Immunogenicity of Hexavalent Group B Streptococcus Conjugate Vaccine Manufactured by Inventprise Inc in Healthy Non-Pregnant Adult Women of Childbearing Age WOCBA in the US and South Africa
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
To assess the safety and tolerability of IVT GBS-06 vaccine administered as a single-dose regimen at three dosage levels in healthy non-pregnant adult women of childbearing age WOCBA
Detailed Description:
This is a phase III randomized placebo-controlled observer-blinded trial to evaluate the safety tolerability and immunogenicity of a multivalent GBS vaccine candidate in healthy non-pregnant adult WOCBA 18-49 years of age at two sites one each in the US and South Africa Approximately 600 participants will be randomized to receive a single dose of low mid or high concentration of IVT GBS-06 or a placebo saline control at Day D1 administered IM by injecting 05 mL into the deltoid muscle The three dose levels denote the amount of capsular polysaccharide CPS for each of the six serotypes per 05 mL These four study groups will be enrolled simultaneously to allow for parallel assessments of overall IVT GBS-06 safety and tolerability Participants will be randomized in a 1111 ratio to one of the dose levels or placebo This study will utilize a sentinel-cohort design in which 20 participants overall ie N5 per treatment arm at the US site will be randomized vaccinated and evaluated for safety prior to opening enrolment of additional participants in USA and in South Africa This study targets representation from both study populations and therefore at least 220 participants will be recruited from each of the two sites and will allow competitive enrollment across the two study sites for the remaining 160 participants to reach 600 within target enrollment period
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