CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 270 enrolled
Drug / intervention
Group B streptococcus vaccinebiological
Likely dose
Group B streptococcus vaccine 5 μgfrom 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.

Search/NCT01412801
NCT01412801Phase 2Completed
CompareCT.gov

A Phase II Open-Label, Multi-Center Study of a Group B Streptococcus Vaccine in HIV Positive and HIV Negative Pregnant Women

Novartis Vaccines·interventional·Posted Aug 9, 2011·Updated Sep 12, 2014

In Brief

A Phase 2 clinical trial evaluating Group B streptococcus vaccine for Streptococcal Infections and 2 related conditions. Completed, enrolled 270 participants across 2 sites in 2 countries.

Detailed Summary

The study compared the magnitude of the antibody response and safety of a GBS Trivalent Vaccine in HIV positive and HIV negative pregnant women and their offspring. In addition the study investigated the maternal to fetal transfer of antibodies induced by the investigational vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStreptococcal Infections, Gram-Positive Bacterial Infections, Bacterial Infections
CountriesMalawi, South Africa
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 9, 2011
Enrollment StartSep 1, 2011
Primary CompletionOct 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 14.9 years ago

Interventions

Group B streptococcus vaccinebiological

Subjects receive one dose of 5 μg of each of the 3 glycoconjugates present in the Group B streptococcus vaccine.