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Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women

NCT05154578 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2025-06-11

Study results available
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Summary

This is a phase II, multicentre, multinational, randomized, parallel group, placebo-controlled study of four vaccination regimens in healthy pregnant women. There will be 5 treatment groups; three groups of 60 participants will receive will receive two doses of GBS-NN/NN2 vaccine and one dose of placebo (saline); one group of 60 participants will receive one dose of GBS-NN/NN2 vaccine and two doses of placebo (saline), and one group of 30 participants will receive three doses of placebo (saline).

Conditions

  • Group B Streptococcal Infection

Interventions

BIOLOGICAL

GBS-NN/NN2 Vaccine

0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection.

BIOLOGICAL

Placebo

0.5 mL normal saline given by intramuscular injection

Sponsors & Collaborators

  • Larix A/S

    collaborator INDUSTRY

  • Minervax ApS

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-17
Primary Completion
2023-04-26
Completion
2023-10-18
FDA Drug
Yes

Countries

  • Denmark
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT05154578 on ClinicalTrials.gov