CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 enrolled
Drug / intervention
GBS-NN/NN2 with Alhydrogel® 25 +3 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.

Search/NCT03807245
NCT03807245Phase 1Completed
CompareCT.gov

A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Group B Streptococcus Vaccine (GBS-NN/NN2 With Alhydrogel®) in Healthy Female Subjects Aged 18 to 40

Minervax ApS·interventional·Posted Jan 16, 2019·Updated Feb 2, 2021

In Brief

A Phase 1 clinical trial evaluating GBS-NN/NN2 with Alhydrogel® 25, Placebo GBS-NN/NN2 with Alhydrogel® 25, and 2 other interventions for Group B Strep Infection. Completed, enrolled 60 participants across 1 site.

Detailed Summary

A Phase I, randomised, single centre, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGroup B Strep Infection
CountriesUnited Kingdom
CollaboratorsSimbec Research

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJan 16, 2019
Enrollment StartJan 9, 2019
Primary CompletionOct 14, 2019
Study CompletionMay 7, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.5 years ago

Interventions

GBS-NN/NN2 with Alhydrogel® 25biological

GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart

Placebo GBS-NN/NN2 with Alhydrogel® 25biological

GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart

Placebo GBS-NN/NN2 with Alhydrogel® 50biological

GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart

GBS-NN/NN2 with Alhydrogel® 50biological

GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart