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Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women

NCT01150123 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 678

Last updated 2017-05-15

Study results available
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Summary

This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.

Conditions

  • Group B Streptococcus

Interventions

BIOLOGICAL

Group B streptococcus (GBS) vaccine- low dose

BIOLOGICAL

Group B streptococcus (GBS) vaccine- High dose

BIOLOGICAL

Placebo- Saline

Sponsors & Collaborators

Principal Investigators

  • Novartis Vaccines · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-11-30
Completion
2012-10-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Companies

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 NCT01150123 on ClinicalTrials.gov