# Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age

> **NCT01193920** · PHASE1,PHASE2 · COMPLETED · sponsor: **Novartis Vaccines** · enrollment: 380 (actual)

## Conditions studied

- Streptococcal Infections

## Interventions

- **BIOLOGICAL:** Group B Streptococcus Trivalent Vaccine - 20/20/20 μg
- **OTHER:** Saline solution
- **BIOLOGICAL:** Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg
- **BIOLOGICAL:** Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg
- **BIOLOGICAL:** Group B Streptococcus Trivalent Vaccine - 5/5/5 μg
- **OTHER:** saline solution

## Key facts

- **NCT ID:** NCT01193920
- **Lead sponsor:** Novartis Vaccines
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2010-10
- **Primary completion:** 2011-12
- **Final completion:** 2012-12
- **Target enrollment:** 380 (ACTUAL)
- **Last updated:** 2014-08-22


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01193920

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01193920, "Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age". Retrieved via AI Analytics 2026-06-09 from https://api.ai-analytics.org/clinical/NCT01193920. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*