CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 380 enrolled
Drug / intervention
Group B Streptococcus Trivalent Vaccine - 20/20/20 μg +5 morebiological
Likely dose
Group B Streptococcus Trivalent Vaccine - 20/20/20 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/NCT01193920
NCT01193920Phase 2Completed
CompareCT.gov

A Phase Ib/II Randomized, Observer-Blind, Controlled, Single Centre Study of a Trivalent Group B Streptococcus Vaccine in Healthy Non-Pregnant Women Leading Into a Dose-Ranging Study in Pregnant Women in South Africa

Novartis Vaccines·interventional·Posted Sep 2, 2010·Updated Aug 22, 2014

In Brief

A Phase 2 clinical trial evaluating Group B Streptococcus Trivalent Vaccine - 20/20/20 μg, Saline solution, and 4 other interventions for Streptococcal Infections. Completed, enrolled 380 participants across 1 site.

Detailed Summary

This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStreptococcal Infections
CountriesSouth Africa
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2, 2010
Enrollment StartOct 1, 2010
Primary CompletionDec 1, 2011
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.8 years ago

Interventions

Group B Streptococcus Trivalent Vaccine - 20/20/20 μgbiological

Subjects received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.

Saline solutionother

Subjects received two injection of saline solution.

Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μgbiological

Subjects received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.

Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μgbiological

Subjects received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.

Group B Streptococcus Trivalent Vaccine - 5/5/5 μgbiological

Subjects received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.

saline solutionother

Subjects received one injection of saline solution.