At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 86 enrolled
Drug / intervention
Group B Streptococcus Trivalent Vaccine +1 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 II Randomized, Observer-Blind, Multi-Center, Controlled Study of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women
In Brief
A Phase 2 clinical trial evaluating Group B Streptococcus Trivalent Vaccine and Placebo for Streptococcal Infection and 2 related conditions. Completed, enrolled 86 participants across 5 sites in 2 countries.
Detailed Summary
The study investigated the immune response induced by the Group B streptococcus vaccine in healthy pregnant women. In addition, the study investigated the amount of vaccine induced antibodies which were transferred to the newborn.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Canada
CollaboratorsNovartis Vaccines
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2011
First PostedOct 2011
Primary CompletionApr 2013
Study CompletionOct 2013
TodayJul 2026
First PostedOct 5, 2011
Enrollment StartSep 1, 2011
Primary CompletionApr 1, 2013
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.7 years ago
Interventions
Group B Streptococcus Trivalent Vaccinebiological
Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine administered intramuscularly.
Placebobiological
Pregnant women who received one injection of saline solution administered intramuscularly.