At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 240 enrolled
Drug / intervention
GBS-NN vaccinebiological
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 Two-part, Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability and Immunogenicity of a Dose Range og Group B Streptococcus Vaccine in Healthy Female Volunteers Aged 18 to 40.
In Brief
A Phase 1 clinical trial evaluating GBS-NN vaccine for Infection by Streptococcus Group B. Completed, enrolled 240 participants across 1 site.
Detailed Summary
Part A: The primary objective is to evaluate the safety and tolerability of a potential vaccine against Group B streptococcus. Part B: To evaluate the long term safety profile of the GBS-NN vaccine up to one year following the first dose.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfection by Streptococcus Group B
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMay 2015
First PostedJun 2015
Primary CompletionApr 2017
Study CompletionApr 2017
TodayJul 2026
First PostedJun 2, 2015
Enrollment StartMay 1, 2015
Primary CompletionApr 12, 2017
Study CompletionApr 21, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.1 years ago
Interventions
GBS-NN vaccinebiological
Three dose levels will be administered, with and without Alhydrogel®