drugset / Trial / NCT05782179

Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants

NCT05782179

Phase 1 Completed 90 enrolled Minervax ApS IQVIA Pty Ltd · collab
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2023-03-01
Primary completion
2023-12-14
Completion
2024-05-23

Drugs

EvaluationDrugModalityDoseRoute
Subject GBS-NN/NN2 Vaccine 50 ug
Subject GBS-NN/NN2 Vaccine 125 ug