At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 678 enrolled
Drug / intervention
Group B streptococcus (GBS) vaccine- low dose +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase Ib Randomized, Observer-Blind, Controlled, Single Center, Dose-Ranging Study of a Group B Streptococcus Vaccine in Healthy Women 18-40 Years of Age
In Brief
A Phase 1 clinical trial evaluating Group B streptococcus (GBS) vaccine- low dose, Group B streptococcus (GBS) vaccine- High dose, and 1 other intervention for Group B Streptococcus. Completed, enrolled 678 participants across 1 site.
Detailed Summary
This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGroup B Streptococcus
CountriesBelgium
CollaboratorsGlaxoSmithKline
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2010
First PostedJun 2010
Primary CompletionNov 2011
Study CompletionOct 2012
TodayJul 2026
First PostedJun 24, 2010
Enrollment StartMay 1, 2010
Primary CompletionNov 1, 2011
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.0 years ago
Interventions
Group B streptococcus (GBS) vaccine- low dosebiological
Group B streptococcus (GBS) vaccine- High dosebiological
Placebo- Salinebiological