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Group B Streptococcus Vaccine in Healthy Females

NCT03807245 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-02-02

Study results available
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Summary

A Phase I, randomised, single centre, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus vaccine.

Conditions

  • Group B Strep Infection

Interventions

BIOLOGICAL

GBS-NN/NN2 with Alhydrogel® 25

GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart

BIOLOGICAL

Placebo GBS-NN/NN2 with Alhydrogel® 25

GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart

BIOLOGICAL

Placebo GBS-NN/NN2 with Alhydrogel® 50

GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart

BIOLOGICAL

GBS-NN/NN2 with Alhydrogel® 50

GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • Minervax ApS

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-01-09
Primary Completion
2019-10-14
Completion
2020-05-07

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 NCT03807245 on ClinicalTrials.gov