At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 90 enrolled
Drug / intervention
GBS-NN/NN2 +1 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.
A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of Group B Streptococcus Vaccine (GBS NN/NN2 With Alhydrogel®) in Elderly Participants Aged 55 to 75
In Brief
A Phase 1 clinical trial evaluating GBS-NN/NN2 and Placebo for Group B Streptococcal Infections. Completed, enrolled 90 participants across 1 site.
Detailed Summary
The study is a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of three doses of GBS NN/NN2 with Alhydrogel® (Recombinant protein vaccine against Group B Streptococcus) in elderly participants aged 55 to 75.Participants will be followed up to 6 months after last vaccination.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGroup B Streptococcal Infections
CountriesBelgium
CollaboratorsIQVIA Pty Ltd
Timeline
Phase 1CompletedFinished
202420252026
Enrollment StartMar 2023
First PostedMar 2023
Primary CompletionDec 2023
Study CompletionMay 2024
TodayJul 2026
First PostedMar 23, 2023
Enrollment StartMar 1, 2023
Primary CompletionDec 14, 2023
Study CompletionMay 23, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.3 years ago
Interventions
GBS-NN/NN2biological
GBS-NN/NN2 bound to alhydrogel as an adjuvant
Placebobiological
Normal Saline 0.9 %