Clinical Trial

Phase I/II Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age.

Active, Not Recruiting Phase 1/2
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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).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-09-23; most recent amendment 2025-11-17.
Status change: Recruiting → Active, Not Recruiting 2025-08-27
Status change: Not Yet Recruiting → Recruiting 2025-01-16
Trial Details
NCT Number NCT06611371
Lead Sponsor Inventprise Inc.
Collaborators: PATH
Conditions Group B Streptococcal Infections
Enrollment 600 participants
Start Date 2024-11-12
Primary Completion 2025-08-26 (estimated)
Study Completion 2026-02 (estimated)
Updated on ClinicalTrials.gov 2025-11-18