At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 80 enrolled
Drug / intervention
GBS Trivalent Vaccinebiological
Likely dose
GBS Trivalent 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.
A Phase 2, Non-Randomized, Controlled, Open-Label, Parallel-Group, Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-pregnant Subjects.
In Brief
A Phase 2 clinical trial evaluating GBS Trivalent Vaccine for Bacterial Infection Due to Streptococcus, Group B and Streptococcus Agalactiae. Completed, enrolled 80 participants across 1 site.
Detailed Summary
The objective of this extension study is the initial assessment of safety and immunogenicity of the second dose of GBS Trivalent Vaccine following the time interval that is close to the inter-pregnancy interval observed in the general population.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartMar 2016
Primary CompletionNov 2016
TodayJul 2026
First PostedFeb 24, 2016
Enrollment StartMar 29, 2016
Primary CompletionNov 2, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.4 years ago
Interventions
GBS Trivalent Vaccinebiological
Administration of lyophilized formulation of a GBS trivalent vaccine containing 5 µg of each polysaccharide capsules from serotypes Ia, Ib, and III of Group B Streptococcus conjugated to CRM-197 .