# A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of a Monovalent Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18-40 Years of Age

> **NCT00657683** · PHASE1 · COMPLETED · sponsor: **Novartis Vaccines** · enrollment: 65 (actual)

## Conditions studied

- Invasive Group B Streptococcus (GBS) Disease

## Interventions

- **BIOLOGICAL:** Monovalent GBS-CRM glycoconjugate vaccine
- **BIOLOGICAL:** Placebo

## Key facts

- **NCT ID:** NCT00657683
- **Lead sponsor:** Novartis Vaccines
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2007-12
- **Primary completion:** 2009-04
- **Final completion:** 2009-05
- **Target enrollment:** 65 (ACTUAL)
- **Last updated:** 2011-12-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00657683

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00657683, "A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of a Monovalent Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18-40 Years of Age". Retrieved via AI Analytics 2026-06-26 from https://api.ai-analytics.org/clinical/NCT00657683. Licensed CC0.

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