At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 27 enrolled
Drug / intervention
GBS-NN/NN2biological
Likely dose
GBS-NN/NN2 50 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 follow-on Study to Assess the Safety and Immunogenicity of a Booster Dose of GBS-NN/NN2 Vaccine 1 to 5 Years After GBS-NN/NN2 Recipients in Study MVX0002 Have Completed the Primary Vaccination Course, in Comparison With a Single Dose of GBS-NN/NN2 Administered in Placebo Participants From Study MVX0002 or Vaccine naïve Participants
In Brief
A Phase 1 clinical trial evaluating GBS-NN/NN2 for Group B Streptococcus Infection. Completed, enrolled 27 participants across 1 site.
Detailed Summary
This is an open label booster vaccine follow-up study. Participants who had received a primary course of GBS-NN/NN2 or placebo in Study MVX0002 will be invited to return to receive a booster dose (or first dose in the case of placebo or vaccine naïve participants) 1 to 5 years after the completion of the primary course of vaccination. All participants will receive a single dose of GBS-NN/NN2 containing 50μg of each fusion protein.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGroup B Streptococcus Infection
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedAug 2021
Enrollment StartAug 2021
Primary CompletionAug 2022
TodayJul 2026
First PostedAug 13, 2021
Enrollment StartAug 17, 2021
Primary CompletionAug 5, 2022
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 4.9 years ago
Interventions
GBS-NN/NN2biological
GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS/NN2