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Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine

NCT05005247 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-10-10

Study results available
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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.

Conditions

  • Group B Streptococcus Infection

Interventions

BIOLOGICAL

GBS-NN/NN2

GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS/NN2

Sponsors & Collaborators

  • Minervax ApS

    lead OTHER

Principal Investigators

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-17
Primary Completion
2022-08-05
Completion
2022-08-05

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05005247 on ClinicalTrials.gov