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

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Re-verified, no change to tracked fieldsv4
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Jan 2026 to Aug 26, 2025
    • Study completion date: Mar 2026 to Feb 2026
    • Site details revised at 2 of 2 sites
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2024 to Nov 12, 2024
    • Site details revised at 2 of 2 sites
    • Study title shortened, about 1 word
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06611371
Lead Sponsor Inventprise Inc.
Collaborators: PATH
Conditions
(from sponsor)		 Group B Streptococcal Infections
Related terms Streptococcal Infections
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov