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Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non-pregnant Women 18-40 Years of Age.

NCT02459262 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2021-01-14

Study results available
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Summary

Part A: The primary objective is to evaluate the safety and tolerability of a potential vaccine against Group B streptococcus.

Part B: To evaluate the long term safety profile of the GBS-NN vaccine up to one year following the first dose.

Conditions

  • Infection by Streptococcus Group B

Interventions

BIOLOGICAL

GBS-NN vaccine

Three dose levels will be administered, with and without Alhydrogel®

Sponsors & Collaborators

  • Minervax ApS

    lead OTHER

Principal Investigators

  • Per Fisher, PM/CEO · MinervaX ApS, Ole Maaløes Vej 3, DK-2200 Copenhagen N, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-04-12
Completion
2017-04-21

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 NCT02459262 on ClinicalTrials.gov