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NCT06611371 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age.
A Phase 1 study of Group B Streptococcal Infections, sponsored by Inventprise.
- Active
- Registry status
- Phase 1
- Development phase
- 600
- Enrollment target
- 2
- Study locations
NCT06611371: Active Phase 1 study of Group B Streptococcal Infections, sponsored by Inventprise.
NCT06611371 is a Phase 1 study of Group B Streptococcal Infections that is active but no longer recruiting, run by Inventprise. The registered enrollment target is 600 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (900% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06611371, a Phase 1 study of Group B Streptococcal Infections, is active but no longer recruiting, sponsored by Inventprise.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 600 participants
- Enrollment target
- 2
- Study locations
Study 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).
Primary Outcome
The percentage of participants reporting immediate AE within 30 minutes of vaccination.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL IVT GBS-06
Study Locations (2)
New York
- NYU Grossman School of Medicine - New York
Gauteng
- Wits Vaccines and Infectious Diseases Analytics Research Unit (Wits-VIDA), University of the Witwatersrand - Johannesburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2024-11-12 |
| Est. Completion | 2026-02 |
| Phase | Phase 1 |
What the registry record for NCT06611371 still lists
NCT06611371 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (900% higher).
The record links to 1 condition, with Group B Streptococcal Infections appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06611371 reports a single indexed study location in New York, Gauteng.
Frequently Asked Questions
What is clinical trial NCT06611371 about?
NCT06611371 is a clinical study titled "Phase I/II Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age.". 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).
What is the current status of trial NCT06611371?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 600 participants. The study started on 2024-11-12. Estimated completion is 2026-02.
What conditions does trial NCT06611371 study?
This clinical trial studies the following conditions: Group B Streptococcal Infections.
What interventions are being tested in trial NCT06611371?
The interventions under investigation include: Placebo (BIOLOGICAL), IVT GBS-06 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06611371?
This trial is sponsored by Inventprise, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06611371 being conducted?
This trial has 2 study locations across New York, Gauteng. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06611371's enrollment target sits among peer trials
600 27th of 2000 higher than 1,973 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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