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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.

NCT06611371 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-11-18

No results posted yet for this 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).

Conditions

  • Group B Streptococcal Infections

Interventions

BIOLOGICAL

IVT GBS-06

Hexavalent Group B Streptococcus polysaccharide conjugate vaccine (serotypes Ia, Ib, II, III, V, and VII) administered as a single dose.

BIOLOGICAL

Placebo

0.9% sodium chloride

Sponsors & Collaborators

  • PATH

    collaborator OTHER

  • Inventprise Inc.

    lead INDUSTRY

Principal Investigators

  • Sybil Tasker, MD, MPH, FIDSA · Inventprise Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-12
Primary Completion
2025-08-26
Completion
2026-02-28
FDA Drug
Yes

Countries

  • United States
  • South Africa

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06611371 on ClinicalTrials.gov